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Proclivity ID
18811001
Unpublish
Citation Name
OBG Manag
Specialty Focus
Obstetrics
Gynecology
Surgery
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
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A sizzling hybrid meeting of the Society of Gynecologic Surgeons

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The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

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Dr. Schimpf is Associate Professor, Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, University of Michigan, and Ambulatory Care Clinical Chief, Obstetrics and Gynecology, Ann Arbor, Michigan.

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Dr. Schimpf is Associate Professor, Female Pelvic Medicine and Reconstructive Surgery, Departments of Obstetrics and Gynecology and Urology, University of Michigan, and Ambulatory Care Clinical Chief, Obstetrics and Gynecology, Ann Arbor, Michigan.

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The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

The 47th Annual Scientific Meeting of the Society of Gynecologic Surgeons (SGS), like so many things in our modern world, endured many changes and had to stay nimble and evolve to changing times. In the end, however, SGS was able to adapt and succeed, just like a skilled gynecologic surgeon in the operating room, to deliver a fresh new type of meeting.

When we chose the meeting theme, “Working together: How collaboration enables us to better help our patients,” we anticipated a meeting discussing medical colleagues and consultants. In our forever-changed world, we knew we needed to reinterpret this to a broader social context. Our special lectures and panel discussions sought to open attendees’ eyes to disparities in health care for people of color and women.

While we highlighted the realities faced by colleagues in medicine, the topics addressed also were designed to grow awareness about struggles our patients encounter as well. Social disparities are sobering, long-standing, and sometimes require creative collaborations to achieve successful outcomes for all patients. The faculty of one of our postgraduate courses reviews in this special 2-part section to OBG Management strategies on dismantling racism, and Christine Heisler, MD, MS, and Sarah M. Temkin, MD, summarize their recent research and special lecture on gender equity in gynecologic surgery (see part 2 of this series in next month’s issue of OBG Management).

The meeting also kicked off with a postgraduate course on fibroid management, with workshops on harnessing the power of social media and lessons on leadership from a female Fortune 500 CEO, Lori Ryerkerk, offered as well. As the scientific program launched, we were once again treated to strong science on gynecologic surgery, with only a small dip in abstract submissions, despite the challenges of research during a pandemic. Mark Walters, MD, gave the inaugural lecture in his name on the crucial topic of surgical education and teaching. We also heard a special report from the SGS SOCOVID research group, led by Dr. Rosanne Kho, on gynecologic surgery during the pandemic. We also convened a virtual panel for our hybrid attendees on the benefits to patients of a multidisciplinary approach to gynecologic surgery, presented here by Cecile Ferrando, MD.

As our practices continue to grow and evolve, the introduction of innovative technologies can pose a new challenge, as Miles Murphy, MD, and members of the panel on novel gynecologic office procedures will present in this series next month.

The TeLinde keynote speaker was Janet Dombrowski, who works as a coach for many surgeons in various disciplines across the country. She spoke to the resilience gained through community and collaboration.

While our meeting theme dated to the “before” pandemic era, those who were able to be in attendance in person can attest to the value we can all place now on community and personal interactions. With experience strengthened by science, I hope this meeting summary serves to highlight the many ways in which we can collaborate to improve outcomes for ourselves in medicine and for patients. 

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2021 Update on female sexual health

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Tue, 08/24/2021 - 12:12

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This was a retrospective study with no control or comparison group and short-term follow-up. The VAS scores were obtained 1 month after the final treatment. Failure to request additional treatment at 8 to 20 months cannot be used to infer that the therapeutic improvements recorded at 1 month were enduring. In addition, although the large number of patients in this study may lead to statistical significance, clinical significance is still questionable. Given the lack of a comparison group and the very short follow-up, it is hard to draw any scientifically valid conclusions from this study.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

 

 

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This study is problematic in several areas. Although it was a prospective, randomized trial, it was not blinded, and the therapeutic interventions were markedly different in nature and requirement for individual patient motivation. The experiences of sexual dysfunction among the participants were not stratified by type—arousal, desire, lubrication, orgasm, or pain. All patients had regular cyclic menses; however, the authors do not report on contraceptive methods, hormonal therapy, or other comorbid conditions that could impact sexual health. The cohorts may or may not have been similar in baseline types of sexual dissatisfaction.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

 

 

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As a monotherapy, CO2 laser therapy is not effective in treating lichen sclerosus, although it may help improve symptoms as an adjunct to high potency steroid therapy when topical treatment alone has failed to provide adequate response.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

 

 

Expert insights on new data

 

Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.1

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”2

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.2

A problem with our VeLVET trial,3 which was published in Menopause, and the Cruz and colleagues’ trial from South America,4 both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.5 For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.2 According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.5

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,2 and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,4 or even our trial that compared vaginal estrogen with laser,3 when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

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The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This was a retrospective study with no control or comparison group and short-term follow-up. The VAS scores were obtained 1 month after the final treatment. Failure to request additional treatment at 8 to 20 months cannot be used to infer that the therapeutic improvements recorded at 1 month were enduring. In addition, although the large number of patients in this study may lead to statistical significance, clinical significance is still questionable. Given the lack of a comparison group and the very short follow-up, it is hard to draw any scientifically valid conclusions from this study.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

 

 

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This study is problematic in several areas. Although it was a prospective, randomized trial, it was not blinded, and the therapeutic interventions were markedly different in nature and requirement for individual patient motivation. The experiences of sexual dysfunction among the participants were not stratified by type—arousal, desire, lubrication, orgasm, or pain. All patients had regular cyclic menses; however, the authors do not report on contraceptive methods, hormonal therapy, or other comorbid conditions that could impact sexual health. The cohorts may or may not have been similar in baseline types of sexual dissatisfaction.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

 

 

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As a monotherapy, CO2 laser therapy is not effective in treating lichen sclerosus, although it may help improve symptoms as an adjunct to high potency steroid therapy when topical treatment alone has failed to provide adequate response.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

 

 

Expert insights on new data

 

Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.1

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”2

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.2

A problem with our VeLVET trial,3 which was published in Menopause, and the Cruz and colleagues’ trial from South America,4 both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.5 For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.2 According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.5

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,2 and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,4 or even our trial that compared vaginal estrogen with laser,3 when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

The approach to diagnosis and treatment of female sexual function continues to be a challenge for women’s health professionals. The search for a female “little blue pill” remains elusive as researchers struggle to understand the mechanisms that underlie the complex aspects of female sexual health. This Update will review the recent literature on the use of fractional CO2 laser for treatment of female sexual dysfunction and vulvovaginal symptoms. Bottom line: While the quality of the studies is poor overall, fractional CO2 laser treatment seems to temporarily improve symptoms of genitourinary syndrome of menopause (GSM). The duration of response, cost, and the overall long-term impact on sexual health remain in question.

A retrospective look at CO2 laser and postmenopausal GSM

Filippini M, Luvero D, Salvatore S, et al. Efficacy of fractional CO2 laser treatment in postmenopausal women with genitourinary syndrome: a multicenter study. Menopause. 2019;27:43-49. doi: 10.1097/GME. 0000000000001428.

Researchers conducted a retrospective, multicenter study of postmenopausal women with at least one symptom of GSM, including itching, burning, dyspareunia with penetration, and dryness.

Study details

A total of 171 of the 645 women (26.5%) were oncology patients. Women were excluded from analysis if they used any form of topical therapy within 15 days; had prolapse stage 2 or greater; or had any infection, abscess, or anatomical deformity precluding treatment with the laser.

Patients underwent gynecologic examination and were given a questionnaire to assess vulvovaginal symptoms. Exams occurred monthly during treatment (average, 6.5 months), at 6- and 12-months posttreatment, and then annually. No topical therapy was advised during or after treatment.

Patients received either 3 or 4 fractional CO2 laser treatments to the vulva and/or vagina depending on symptom location and type. Higher power settings of the same laser were used to treat vaginal symptoms (40W; 1,000 microseconds) versus vulvar symptoms (25W; 500 microseconds). Treatment sessions were 5 to 6 minutes. The study authors used a visual analog rating scale (VAS) for “atrophy and related symptoms,” tested vaginal pH, and completed the Vaginal Health Index Score. VAS scores were obtained from the patients prior to the initial laser intervention and 1 month after the final treatment.

Results

There were statistically significant improvements in dryness, vaginal orifice pain, dyspareunia, itching, and burning for both the 3-treatment and 4-treatment cohorts. The delta of improvement was then compared for the 2 subgroups; curiously, there was greater improvement of symptoms such as dryness (65% vs 61%), itching (78% vs 72%), burning (72% vs 67%), and vaginal orifice pain (67% vs 60%) in the group that received 3 cycles than in the group that received 4 cycles.

With regard to vaginal pH improvement, the 4-cycle group performed better than the 3-cycle group (1% improvement in the 4-cycle group vs 6% in the 3-cycle group). Although vaginal pH reduction was somewhat better in the group that received 4 treatments, and the pre versus posttreatment percentages were statistically significantly different, the clinical significance of a pH difference between 5.72 and 5.53 is questionable, especially since there was a greater difference in baseline pH between the two cohorts (6.08 in the 4-cycle group vs 5.59 in the 3-cycle group).

There were no reported adverse events related to the fractional laser treatments, and 6% of the patients underwent additional laser treatments during the followup timeframe of 8 to 20 months.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This was a retrospective study with no control or comparison group and short-term follow-up. The VAS scores were obtained 1 month after the final treatment. Failure to request additional treatment at 8 to 20 months cannot be used to infer that the therapeutic improvements recorded at 1 month were enduring. In addition, although the large number of patients in this study may lead to statistical significance, clinical significance is still questionable. Given the lack of a comparison group and the very short follow-up, it is hard to draw any scientifically valid conclusions from this study.

Continue to: Randomized data on CO2 laser vs Kegels for sexual dysfunction...

 

 

Randomized data on CO2 laser vs Kegels for sexual dysfunction

Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

In a small randomized controlled trial (RCT) conducted in China, Lou and colleagues identified premenopausal women at “high risk” for sexual dysfunction as determined by the Chinese version of the Female Sexual Function Index (CFSFI).

Details of the study

A total of 84 women (mean age, 36.5 years) were included in the study. All the participants were heterosexual and married or with a long-term partner. The domain of sexual dysfunction was not considered. Women were excluded if they had no current heterosexual partner; had genital malformation, urinary incontinence, or prolapse stage 2 or higher; a history of pelvic floor mesh treatment; current gynecologic malignancy; abnormal cervical cytology; or were currently pregnant or postpartum. In addition, women were excluded if they had been treated previously for sexual dysfunction or mental “disease.” The cohort was randomized to receive fractional CO2 laser treatments (three 15-minute treatments 1 month apart at 60W, 1,000 microseconds) or coached Kegel exercises (10 exercises repeated twice daily at least 3 times/week and monitored by physical therapists at biweekly clinic visits). Sexual distress was evaluated by using the Female Sexual Distress Scale-Revised (FSDSR). Outcomes measured were pelvic floor muscle strength and scores on the CFSFI and FSDSR. Data were obtained at 3, 6, 9, and 12 months after initiation of therapy.

Both groups showed improvement

The laser cohort showed slightly more improvement in scale scores at 6 and 12 months. Specifically, the laser group had better scores on lubrication and overall satisfaction, with moderate effect size; neither group had improvements in arousal, desire, or orgasm. The Kegel group showed a significant improvement in pelvic floor strength and orgasm at 12 months, an improvement not seen in the laser cohort. Both groups showed gradual improvement in the FSDSR, with the laser group reporting a lower score (10.0) at 12 months posttreatment relative to the Kegel group (11.1). Again, these were modest effects as baseline scores for both cohorts were around 12.5. There were minimal safety signals in the laser group, with 22.5% of women reporting scant bloody discharge posttreatment and 72.5% describing mild discomfort (1 on a 1–10 VAS scale) during the procedure.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
This study is problematic in several areas. Although it was a prospective, randomized trial, it was not blinded, and the therapeutic interventions were markedly different in nature and requirement for individual patient motivation. The experiences of sexual dysfunction among the participants were not stratified by type—arousal, desire, lubrication, orgasm, or pain. All patients had regular cyclic menses; however, the authors do not report on contraceptive methods, hormonal therapy, or other comorbid conditions that could impact sexual health. The cohorts may or may not have been similar in baseline types of sexual dissatisfaction.

CO2 laser for lichen sclerosus: Is it effective?

Pagano T, Conforti A, Buonfantino C, et al. Effect of rescue fractional microablative CO2 laser on symptoms and sexual dysfunction in women affected by vulvar lichen sclerosus resistant to long-term use of topic corticosteroid: a prospective longitudinal study. Menopause. 2020;27:418-422. doi: 10.1097 /GME.0000000000001482.

Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:968-978. doi: 10.1097 /AOG.0000000000004332.

Mitchell L, Goldstein AT, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097 /AOG.0000000000004409.

High potency corticosteroid ointment is the current standard treatment for lichen sclerosus. Alternative options for disease that is refractory to steroids are limited. Three studies published in the past year explored the CO2 laser’s ability to treat lichen sclerosus symptoms and resultant sexual dysfunction—Pagano and colleagues conducted a small prospective study and Burkett and colleagues and Mitchell et al conducted small RCTs.

Details of the Pagano study

Three premenopausal and 37 postmenopausal women with refractory lichen sclerosus (defined as no improvement after 4 cycles of ultra-high potency steroids) were included in the study. Lichen sclerosus was uniformly biopsy confirmed. Women using topical or systemic hormones were excluded. VAS was administered prior to initial treatment and after each of 2 fractional CO2 treatments (25–30 W; 1,000 microseconds) 30 to 40 days apart to determine severity of vulvar itching, dyspareunia with penetration, vulvar dryness, sexual dysfunction, and procedure discomfort. Follow-up was conducted at 1 month after the final treatment. VAS score for the primary outcome of vulvar itching declined from 8 pretreatment to 6 after the first treatment and to 3 after the second. There was no significant treatment-related pain reported.

The authors acknowledged the limitations of their study; it was a relatively small sample size, nonrandomized and had short-term follow-up of a mixed patient population and no sham or control group. The short-term improvements reported in the study patients may not be sustained without ongoing treatment for a lifelong chronic disease, and the long-term potential for development of squamous cell carcinoma may or may not be ameliorated.

Continue to: Burkett et al: RCT study 1...

 

 

Burkett et al: RCT study 1

A total of 52 postmenopausal patients with biopsy-proven lichen sclerosus were randomly assigned to clobetasol or CO2 laser; 51 women completed 6-month follow-up. The outcomes were stratified by prior high-potency steroid use. The steroid cohort used clobetasol 0.05% nightly for 1 month, 3 times per week for 2 months, then as needed. The laser cohort received 3 treatments (26 W; 800 microseconds) 4 to 6 weeks apart. Overall adherence was only 75% in the clobetasol group, compared with 96% in the laser group. The authors found treatment efficacy of CO2 laser therapy only in the group of patients who had prior treatment with high potency topical corticosteroids. They conclude that, …“Despite previously optimistic results in well designed clinical trials of fractionated CO2 for genitourinary syndrome of menopause, and in noncontrolled case series for vulvar lichen sclerosus, our study failed to show any significant benefit of monotherapy of fractionated CO2 for vulvar lichen sclerosus. There may be a role for fractionated CO2 as an adjuvant therapy along with topical ultrapotent corticosteroids in vulvar lichen sclerosus.”

Mitchell et al: RCT study 2

This was a double blind, placebo-controlled, and histologically validated study of fractional CO2 for treatment of lichen sclerosus in 35 women; 17 in the treatment arm and 18 in the sham laser encounters. At least a 4-week no treatment period of topical steroids was required before monotherapy with CO2 laser was initiated.

The authors found no difference in their primary outcome—histopathology scale scores—after 5 treatments over 24 weeks. Secondary endpoints were changes in the CSS (Clinical Scoring System for Vulvar Lichen Sclerosus), a validated instrument that includes both a clinician’s examination of the severity of disease and a patient’s report of the severity of her symptoms. The patient score is the total of 4 domains: itching, soreness, burning, and dyspareunia. The clinician objective examination documents fissures, erosions, hyperkeratosis, agglutination, stenosis, and atrophy. At the conclusion of treatment there were no significant differences in the patient reported symptoms or the clinical findings between the active treatment and sham groups.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
As a monotherapy, CO2 laser therapy is not effective in treating lichen sclerosus, although it may help improve symptoms as an adjunct to high potency steroid therapy when topical treatment alone has failed to provide adequate response.

Conclusion

The quality of evidence to support the use of the CO2 laser for improvement in sexual dysfunction is poor. Although patient satisfaction scores improved overall, and most specifically for symptoms related to GSM, the lack of blinding; inappropriate or no control groups; the very short-term outcomes; and for one of the studies, the lack of a clear definition of sexual dysfunction, make it difficult to draw meaningful conclusions for clinical care.

For GSM, we know that topical estrogen therapy works—and with little to no systemic absorption. The CO2 laser should be studied in comparison to this gold standard, with consideration of costs and potential long-term harms in addition to patient satisfaction and short-term measures of improvement. In addition, and very importantly, it is our professional responsibility to present the evidence for safety of topical estrogens to our professional colleagues as well as to our patients with estrogen-dependent cancers so that they understand the value of estrogen as a safe and appropriate alternative to expensive and potentially short-term interventions such as CO2 laser treatment. ●

 

 

Expert insights on new data

 

Cheryl Iglesia, MD

Dr. Iglesia is Director, Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, and Professor, Departments of ObGyn and Urology, Georgetown University School of Medicine, Washington, DC. She is a member of the OBG Management Board of Editors.

Barbara Levy, MD: Cheryl, you have more experience with use of the energy-based cosmetic laser than most ObGyns, and I thought that speaking with you about this technology would be of benefit, not only to me in learning more about the hands-on experience of a lead researcher and practitioner but also readers who are hearing more and more about the growth of cosmetic gynecology in general. Thank you for taking the time today.

Cheryl Iglesia, MD: I’m happy to speak about this with you, Barbara.

Dr. Levy: Specifically, I would like to talk about use of these technologies for sexual dysfunction. In the last few years some of the available data have been on the CO2 laser versus physical therapy, which is not an appropriate comparison.1

Dr. Iglesia: There have been limited data, and less randomized, controlled data, on laser and radiofrequency energies for cosmetic gynecology, and in fact these devices remain unapproved for any gynecologic indication. In 2018 the US Food and Drug Administration (FDA) issued a Safety Communication about the use of energy-based devices to perform vaginal rejuvenation or cosmetic procedures. The International Urogynecological Association (IUGA) issued a consensus statement echoing concerns about the devices, and an International Continence Society/International Society for the Study of Vulvovaginal Disease Best Practice Consensus Statement did not recommend the laser for “routine treatment of vaginal atrophy or urinary incontinence unless treatment is part of a well-designed trial or with special arrangements for clinical governance, consent, and audit.”2

In May 2020, as evidence remains limited (although 522 studies are ongoing in coordination with the FDA), the American Urogynecologic Society (AUGS) published a clinical consensus statement from a panel of experts in female pelvic medicine and reconstructive surgery. The panel had about 90% consensus that there is short-term efficacy for the laser with GSM and dyspareunia. But we only have outcomes data that lasts a maximum of 1 year.2

A problem with our VeLVET trial,3 which was published in Menopause, and the Cruz and colleagues’ trial from South America,4 both of which compared the CO2 laser to estrogen and had randomized groups, was that they were limited by the outcome measures used, none of which were consistently validated. But these studies also had small numbers of participants and short-term follow-up. So I don’t think there are much existing data that are promising for supporting energy-based treatment for GSM.

We also have just-published data on the laser for lichen sclerosus.5 For the AUGS panel, there was about 80% consensus for energy-based-device use and lichen sclerosus.2 According to Mitchell et al, who conducted a small, randomized, sham-controlled trial, CO2 laser resulted in no significant difference in histopathology scale score between active and sham arms.5

Future trials may want to assess laser as a mechanism for improved local drug delivery (eg, use of combined laser plus local estrogen for GSM or combined laser plus topical steroid for lichen sclerosus). I am also aware that properly designed laser versus sham studies are underway.

Dr. Levy: What about for stress urinary incontinence (SUI)? I don’t think these technologies are going to work.

Dr. Iglesia: For the AUGS panel, there was only about 70% consensus for energy-based-device use and SUI,2 and I’m one of the naysayers. The pathophysiology of SUI is so multifactorial that it’s hard to believe that laser or radiofrequency wand therapy could have sustained improvements, especially since prior radiofrequency therapy from the last decade (for instance, Renessa, Novasys Medical) did not show long-term efficacy.

Understanding lasers and coordinating care

Dr. Levy: We don’t know what the long-term outcomes are for the CO2 laser and GSM.

Dr. Iglesia: I agree with you, and I think there needs to be an understanding of the mechanism of how lasers work, whether it be erbium (Er:YAG), which is the most common, or CO2. Erbium and CO2 lasers, which are on the far-infrared spectrum, target the chromophore, water. My feeling is that, when you look at results from the Cruz trial,4 or even our trial that compared vaginal estrogen with laser,3 when there is severe GSM and high pH with virtually no water present in the tissues, that laser is not going to properly function. But I don’t think we know exactly what optimal pretreatment is necessary, and that is one of the problems. Furthermore, when intravaginal lasers are done and no adequate speculum exam is conducted prior to introducing the laser, there could be discharge or old creams present that block the mirrors necessary to adequately fire the fractionated laser beams.

Unfortunately, oftentimes these devices are marketed to women with breast cancer, who may be taking aromatase inhibitors, which cause the no-water problem; they dry out everything. They are effective for preventing breast cancer recurrence, but they cause severe atrophy (perhaps worse than many of the other selective estrogen-receptor modulators), with a resultant high vaginal pH. If we can bring that pH level down, closer to the normal 4.5 range so that we could have some level of moisture, and add estrogen first, the overall treatment approach will probably be more effective. We still do not know what happens after 1 year, though, and how often touch-ups need to be performed.

In fact, when working with a patient with breast cancer, I will speak with her oncologist; I will collaborate to put in place a treatment plan that may include initial pretreatment with low-dose vaginal estrogen followed by laser treatment for vaginal atrophy. But I will make sure I use the lowest dose. Sometimes when the patient comes back, the estrogen’s worked so well she’ll say, “Oh, I’m happy, so I don’t need the laser anymore.” A balanced conversation is necessary, especially with cancer survivors.

Informing patients and colleagues

Dr. Levy: I completely agree, and I think one of the key points here is that our purpose is to serve our patients. The data demonstrate that low doses of vaginal estrogen are not harmful for women who are being treated for or who have recovered from breast cancer. It is our ethical obligation to convince these women and their oncologists that ongoing treatment with vaginal estrogen not only will help their GSM but also their overactive bladder and their risk of urinary tract infections and other things. We could be exploiting patients who are really fearful of using any estrogen because of a perceived cancer risk. We could actually be validating their fear by telling them we have an alternative treatment for which they have to pay cash.

Treatment access

Dr. Iglesia: Yes, these are not cosmetic conditions that we are treating. So my goal when evaluating treatment for refractory GSM or lichen sclerosus is to find optimal energy-based therapies with the hope that one day these will be approved gynecologic conditions by the US FDA for laser and wand therapies and that they will ultimately not be out-of-pocket expenses but rather therapies covered by insurance.

Dr. Levy: Great. I understand that AUGS/IUGA have been working on a terminology algorithm to help distinguish between procedures being performed to resolve a medical problem such as prolapse or incontinence versus those designed to be cosmetic.

Dr. Iglesia: Yes, there is a big document from experts in both societies out for public comment right now. It will hopefully be published soon.

Outstanding questions remain

Dr. Levy: Really, we as ObGyns shouldn’t be quick to incorporate these things into our practices without high-quality studies demonstrating value. I have a major concern about these devices in the long term. When you look at fractional CO2 use on the face, for instance, which is a much different type of skin than the vagina, the laser builds collagen—but we don’t have long-term outcome results. The vagina is supposed to be an elastic tissue, so what is the risk of long-term scarring there? Yes, the laser builds collagen in the vaginal epithelium, but what does it do to scarring in the rest of the tissue? We don’t have answers to that.

Dr. Iglesia: And that is the question—how does histology equate with function? Well, I would go with what the patients are reporting.

Dr. Levy: Absolutely. But the thing about vaginal low-dose estrogen is that it is something that the oncologists or the ObGyns could be implementing with patients while they are undergoing cancer therapy, while in their menopausal transition, to preserve vulvovaginal function as opposed to trying to regain it.

Dr. Iglesia: Certainly, although it still needs to be determined when that type of approach would actually be contraindicated.

Dr. Levy: Thank you, Cheryl, for your valuable insights.

Dr. Iglesia: Of course. Thank you. ●

References

1. Lou W, Chen F, Xu T, et al. A randomized controlled study of vaginal fractional CO2 laser therapy for female sexual dysfunction. Lasers Med Sci. March 15, 2021. doi: 10.1007/s10103-021-03260-x.

2. Alshiek J, Garcia B, Minassian V, et al. Vaginal energy-based devices. Female Pelvic Med Reconstr Surg. 2020;26:287-298. doi: 10.1097 /SPV.0000000000000872.

3. Paraiso MF, Ferrando CA, et al. A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: the VeLVET Trial. Menopause. 2020;27:50-56. doi: 10.1097/GME.0000000000001416.

4. Cruz VL, Steiner ML, et al. Randomized, double-blind, placebo-controlled clinical trial for evaluating the efficacy of fractional CO2 laser compared with topical estriol in the treatment of vaginal atrophy in postmenopausal women. Menopause. 2018;25:21-28. doi: 10.1097 /GME.0000000000000955.

5. Mitchell L, Goldstein A, Heller D, et al. Fractionated carbon dioxide laser for the treatment of vulvar lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137:979-987. doi: 10.1097/AOG.0000000000004409.

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A multidisciplinary approach to gyn care: A single center’s experience

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In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
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Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

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Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

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Cecile A. Ferrando, MD, MPH

Associate Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio.

Katie Propst, MD

Urogynecologist, Assistant Professor, Obstetrics and Gynecology, Subspecialty Care for Women’s Health, Cleveland Clinic, Cleveland, Ohio

 

Dr. Ferrando reports receiving royalties from UpToDate, Inc. Dr. Propst reports no financial relationships relevant to this article.

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In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

In her book The Silo Effect: The Peril of Expertise and the Promise of Breaking Down Barriers, Gillian Tett wrote that “the word ‘silo’ does not just refer to a physical structure or organization (such as a department). It can also be a state of mind. Silos exist in structures. But they exist in our minds and social groups too. Silos breed tribalism. But they can also go hand in hand with tunnel vision.”

Tertiary care referral centers seem to be trending toward being more and more “un-siloed” and collaborative within their own departments and between departments in order to care for patients. The terms multidisciplinary and intradisciplinary have become popular in medicine, and teams are joining forces to create care paths for patients that are intended to improve the efficiency of and the quality of care that is rendered. There is no better example of the move to improve collaboration in medicine than the theme of the 2021 Society of Gynecologic Surgeons annual meeting, “Working Together: How Collaboration Enables Us to Better Help Our Patients.”

In this article, we provide examples of how collaborating with other specialties—within and outside of an ObGyn department—should become the standard of care. We discuss how to make this team approach easier and provide evidence that patients experience favorable outcomes. While data on combined care remain sparse, the existing literature on this topic helps us to guide and counsel patients about what to expect when a combined approach is taken.

Addressing pelvic floor disorders in women with gynecologic malignancy

In 2018, authors of a systematic review that looked at concurrent pelvic floor disorders in gynecologic oncologic survivors found that the prevalence of these disorders was high enough to warrant evaluation and management of these conditions to help improve quality of life for patients.1 Furthermore, it is possible that the prevalence of urinary incontinence is higher in patients who have undergone surgery for a gynecologic malignancy compared with controls, which has been reported in previous studies.2,3 At Cleveland Clinic, we recognize the need to evaluate our patients receiving oncologic care for urinary, fecal, and pelvic organ prolapse symptoms. Our oncologists routinely inquire about these symptoms once their patients have undergone surgery with them, and they make referrals for all their symptomatic patients. They have even learned about our own counseling, and they pre-emptively let patients know what our counseling may encompass.

For instance, many patients who received radiation therapy have stress urinary incontinence that is likely related to a hypomobile urethra, and they may benefit more from transurethral bulking than an anti-incontinence procedure in the operating room. Reassuring patients ahead of time that they do not need major interventions for their symptoms is helpful, as these patients are already experiencing tremendous burden from their oncologic conditions. We have made our referral patterns easy for these patients, and most patients are seen within days to weeks of the referral placed, depending on the urgency of the consult and the need to proceed with their oncologic treatment plan.

Gynecologic oncology patients who present with preoperative stress urinary incontinence and pelvic organ prolapse also are referred to a urogynecology specialist for concurrent care. Care paths have been created to help inform both the urogynecologists and the oncologists about options for patients depending on their respective conditions, as both their malignancy and their pelvic floor disorder(s) are considered in treatment planning. There is agreement in this planning that the oncologic surgery takes priority, and the urogynecologic approach is based on the oncologic plan.

Our urogynecologists routinely ask if future radiation is in the treatment plan, as this usually precludes us from placing a midurethral sling at the time of any surgery. Surgical approach (vaginal versus abdominal; open or minimally invasive) also is determined by the oncologic team. At the time of surgery, patient positioning is considered to optimize access for all of the surgeons. For instance, having the oncologist know that the patient needs to be far down on the bed as their steep Trendelenburg positioning during laparoscopy or robotic surgery may cause the patient to slide cephalad during the case may make a vaginal repair or sling placement at the end of the case challenging. All these small nuances are important, and a collaborative team develops the right plan for each patient in advance.

Data on the outcomes of combined surgery are sparse. In a retrospective matched cohort study, our group compared outcomes in women who underwent concurrent surgery with those who underwent urogynecologic surgery alone.4 We found that concurrent surgeries had an increased incidence of minor but not serious perioperative adverse events. Importantly, we determined that 1 in 10 planned urogynecologic procedures needed to be either modified or abandoned as a result of the oncologic plan. These data help guide our counseling, and both the oncologist and urogynecologist contributing to the combined case counsel patients according to these data.

Continue to: Concurrent colorectal and gynecologic surgery...

 

 

Concurrent colorectal and gynecologic surgery

Many women have pelvic floor disorders. As gynecologists, we often compartmentalize these conditions as gynecologic problems; frequently, however, colorectal conditions are at play as well and should be addressed concurrently. For instance, a high incidence of anorectal dysfunction occurs in women who present with pelvic organ prolapse.5 Furthermore, outlet defecation disorders are not always a result of a straightforward rectocele that can be fixed vaginally. Sometimes, a more thorough evaluation is warranted depending on the patient’s concurrent symptoms and history. Outlet symptoms may be attributed to large enteroceles, sigmoidoceles, perineal descent, rectal intussusception, and rectal prolapse.6

As a result, a combined approach to caring for patients with complex pelvic floor disorders is optimal. Several studies describe this type of combined and coordinated patient care.7,8 Ideally, patients are seen by both surgeons in the office so that the surgeons may make a combined plan for their care, especially if the decision is made to proceed with surgery. Urogynecology specialists and colorectal surgeons must decide together whether to approach combined prolapse procedures via a perineal and vaginal approach versus an abdominal approach. Several factors can determine this, including surgeon experience and preference, which is why it is important for surgeons working together to have either well-designed care paths or simply open communication and experience working together for the conditions they are treating.

In an ideal coordinated care approach, both surgeons review the patient records in advance. Any needed imaging or testing is done before the official patient consult; the patient is then seen by both clinicians in the same visit and counseled about the options. This is the most efficient and effective way to see patients, and we have had significant success using this approach.

Complications of combined surgery

The safety of combining procedures such as laparoscopic sacrocolpopexy and concurrent rectopexy has been studied, and intraoperative complications have been reported to be low.9,10 In a cohort study, Wallace and colleagues looked at postoperative outcomes and complications following combined surgery and reported that reoperation for the rectal prolapse component of the surgery was more common than the pelvic organ prolapse component, and that 1 in 5 of their patients experienced a surgical complication within 30 days of their surgery.11 This incidence is higher than that seen with isolated pelvic organ prolapse surgery. These data help us understand that a combined approach requires good patient counseling in the office about both the need for repeat surgery in certain circumstances and the increased risk of complications. Further, combined perineal and vaginal approaches have been compared with abdominal approaches and also have shown no age-adjusted differences in outcomes and complications.12

These data point to the need for surgeons to choose the approach to surgery that best fits their own experiences and to discuss this together before counseling the patient in the office, thus streamlining the effort so that the patient feels comfortable under the care of 2 surgeons.

Patients presenting with urogynecologic and gynecologic conditions also report symptomatic hemorrhoids, and colorectal referral is often made by the gynecologist. Sparse data are available regarding combined approaches to managing hemorrhoids and gynecologic conditions. Our group was the first to publish on outcomes and complications in patients undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery.13 In that retrospective cohort, we found that minor complications, such as postoperative urinary tract infection and transient voiding dysfunction, was more common in patients who underwent combined surgery. From this, we gathered that there is a need to counsel patients appropriately about the risk of combined surgery. That said, for some patients, coordinated care is desirable, and surgeons should make the effort to work together in combining their procedures.

Continue to: Integrating plastic and reconstructive surgery in gynecology...

 

 

Integrating plastic and reconstructive surgery in gynecology

Reconstructive gynecologic procedures often require a multidisciplinary approach to what can be very complex reconstructive surgery. The intended goal usually is to achieve a good cosmetic result in the genital area, as well as to restore sexual, defecatory, and/or genitourinary functionality. As a result, surgeons must work together to develop a feasible reconstructive plan for these patients.

Women experience vaginal stenosis or foreshortening for a number of reasons. Women with congenital anomalies often are cared for by specialists in pediatric and adolescent gynecology. Other women, such as those who have undergone vaginectomy and/or pelvic or vaginal radiation for cancer treatment, complications from vaginal mesh placement, and severe vaginal scarring from dermatologic conditions like lichen planus, are cared for by other gynecologic specialists, often general gynecologists or urogynecologists. In some of these cases, a gynecologic surgeon can perform vaginal adhesiolysis followed by vaginal estrogen treatment (when appropriate) and aggressive postoperative vaginal dilation with adjunctive pelvic floor physical therapy as well as sex therapy or counseling. A simple reconstructive approach may be necessary if lysis of adhesions alone is not sufficient. Sometimes, the vaginal apex must be opened vaginally or abdominally, or releasing incisions need to be made to improve the caliber of the vagina in addition to its length. Under these circumstances, the use of additional local skin grafts, local peritoneal flaps, or biologic grafts or xenografts can help achieve a satisfying result. While not all gynecologists are trained to perform these procedures, some are, and certainly gynecologic subspecialists have the skill sets to care for these patients.

Under other circumstances, when the vagina is truly foreshortened, more aggressive reconstructive surgery is necessary and consultation and collaboration with plastic surgery specialists often is helpful. At our center, these patients’ care is initially managed by gynecologists and, when simple approaches to their reconstructive needs are exhausted, collaboration is warranted. As with the other team approaches discussed in this article, the recommendation is for a consistent referral team that has established care paths for patients. Not all plastic surgeons are familiar with neovaginal reconstruction and understand the functional aspects that gynecologists are hoping to achieve for their patients. Therefore, it is important to form cohesive teams that have the same goals for the patient.

The literature on neovaginal reconstruction is sparse. There are no true agreed on approaches or techniques for vaginal reconstruction because there is no “one size fits all” for these repairs. Defects also vary depending on whether they are due to resections or radiation for oncologic treatment, reconstruction as part of the repair of a genitourinary or rectovaginal fistula, or stenosis from other etiologies.

In 2002, Cordeiro and colleagues published a classification system and reconstructive algorithm for acquired vaginal defects.14 Not all reconstructive surgeons subscribe to this algorithm, but it is the only rubric that currently exists. The authors differentiate between “partial” and “circumferential” defects and recommend different types of fasciocutaneous and myocutaneous flaps for reconstruction.

In our experience at our center, we believe that the choice of flap should also depend on whether or not perineal reconstruction is needed. This decision is made by both the gynecologic specialist and the plastic surgeon. Common flap choices include the Singapore flap, a fasciocutaneous flap based on perforators from the pudendal vessels; the gracilis flap, a myocutaneous flap based off the medial circumflex femoral vessels; and the rectus abdominis flap (transverse or vertical), which is also a myocutaneous flap that relies on the blood supply from the deep inferior epigastric vessels.

One of the most important parts of the coordinated effort of neovaginal surgery is postoperative care. Plastic surgeons play a key role in ensuring that the flap survives in the immediate postoperative period. The gynecology team should be responsible for postoperative vaginal dilation teaching and follow-up to ensure that the patient dilates properly and upsizes her dilator appropriately over the postoperative period. In our practice, our advanced practice clinicians often care for these patients and are responsible for continuity and dilation teaching. Patients have easy access to these clinicians, and this enhances the postoperative experience. Referral to a pelvic floor physical therapist knowledgeable about neovaginal surgery also helps to ensure that the dilation process goes successfully. It also helps to have office days on the same days as the plastic surgery team that is following the patient. This way, the patient may be seen by both teams on the same day. This allows for good patient communication with regard to aftercare, as well as a combined approach to teaching the trainees involved in the case. Coordination with pelvic floor physical therapists on those days also enhances the patient experience and is highly recommended.

Continue to: Combining gyn and urogyn procedures with plastic surgery...

 

 

Combining gyn and urogyn procedures with plastic surgery

While there are no data on combining gynecologic and urogynecologic procedures with plastic reconstructive surgeries, a team approach to combining surgeries is possible. At our center, we have performed tubal ligation, ovarian surgery, hysterectomy, and sling and prolapse surgery in patients who were undergoing cosmetic procedures, such as breast augmentation and abdominoplasty.

Gender affirmation surgery also can be performed through a combined approach between gynecologists and plastic surgeons. Our gynecologists perform hysterectomy for transmasculine men, and this procedure is sometimes safely and effectively performed in combination with masculinizing chest surgery (mastectomy) performed by our plastic surgeons. Vaginoplasty surgery (feminizing genital surgery) also is performed by urogynecology specialists at our center, and it is sometimes done concurrently at the time of breast augmentation and/or facial feminization surgery.

Case order. Some plastic surgeons vocalize concerns about combining clean procedures with clean contaminated cases, especially in situations in which implants are being placed in the body. During these cases, communication and organization between surgeons is important. For instance, there should be a discussion about case order. In general, the clean procedures should be performed first. In addition, separate operating tables and instruments should be used. Simultaneous operating also should be avoided. Fresh incisions should be dressed and covered before subsequent procedures are performed.

Incision placement. Last, planning around incision placement should be discussed before each case. Laparoscopic and abdominal incisions may interfere with plastic surgery procedures and alter the end cosmesis. These incisions often can be incorporated into the reconstructive procedure. The most important part of the coordinated surgical effort is ensuring that both surgical teams understand each other’s respective surgeries and the approach needed to complete them. When this is achieved, the cases are usually very successful.

Creating collaboration between obstetricians and gynecologic specialists

The impacts of pregnancy and vaginal delivery on the pelvic floor are well established. Urinary and fecal incontinence, pelvic organ prolapse, perineal pain, and dyspareunia are not uncommon in the postpartum period and may persist long term. The effects of obstetric anal sphincter injury (OASI) are significant, with up to 25% of women experiencing wound complications and 17% experiencing fecal incontinence at 6 months postpartum.15,16 Care of women with peripartum pelvic floor disorders and OASIs present an ideal opportunity for collaboration between urogynecologists and obstetricians. The Cleveland Clinic has a multidisciplinary Postpartum Care Clinic (PPCC) where we provide specialized, collaborative care for women with peripartum pelvic floor disorders and complex obstetric lacerations.

Our PPCC accepts referrals up to 1 year postpartum for women who experience OASI, urinary or fecal incontinence, perineal pain or dyspareunia, voiding dysfunction or urinary retention, and wound healing complications. When a woman is diagnosed with an OASI at the time of delivery, a “best practice alert” is released in the medical record recommending a referral to the PPCC to encourage referral of all women with OASI. We strive to see all referrals within 2 weeks of delivery.

At the time of the initial consultation, we collect validated questionnaires on bowel and bladder function, assess pain and healing, and discuss future delivery planning. The success of the PPCC is rooted in communication. When the clinic first opened, we provided education to our obstetrics colleagues on the purpose of the clinic, when and how to refer, and what to expect from our consultations. Open communication between referring obstetric clinicians and the urogynecologists that run the PPCC is key in providing collaborative care where patients know that their clinicians are working as a team. All recommendations are communicated to referring clinicians, and all women are ultimately referred back to their primary clinician for long-term care. Evidence demonstrates that this type of clinic leads to high obstetric clinician satisfaction and increased awareness of OASIs and their impact on maternal health.17

Combined team approach fosters innovation in patient care

A combined approach to the care of the patient who presents with gynecologic conditions is optimal. In this article, we presented examples of care that integrates gynecology, urogynecology, gynecologic oncology, colorectal surgery, plastic surgery, and obstetrics. There are, however, many more existing examples as well as opportunities to create teams that really make a difference in the way patients receive—and perceive—their care. This is a good starting point, and we should strive to use this model to continue to innovate our approach to patient care.

References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
References
  1. Ramaseshan AS, Felton J, Roque D, et al. Pelvic floor disorders in women with gynecologic malignancies: a systematic review. Int Urogynecol J. 2018;29:459-476.
  2. Nakayama N, Tsuji T, Aoyama M, et al. Quality of life and the prevalence of urinary incontinence after surgical treatment for gynecologic cancer: a questionnaire survey. BMC Womens Health. 2020;20:148-157.
  3. Cascales-Campos PA, Gonzalez-Gil A, Fernandez-Luna E, et al. Urinary and fecal incontinence in patients with advanced ovarian cancer treated with CRS + HIPEC. Surg Oncol. 2021;36:115-119.
  4. Davidson ER, Woodburn K, AlHilli M, et al. Perioperative adverse events in women undergoing concurrent urogynecologic and gynecologic oncology surgeries for suspected malignancy. Int Urogynecol J. 2019;30:1195-1201.
  5. Spence-Jones C, Kamm MA, Henry MM, et al. Bowel dysfunction: a pathogenic factor in uterovaginal prolapse and stress urinary incontinence. Br J Obstet Gynaecol. 1994;101:147-152.
  6. Thompson JR, Chen AH, Pettit PD, et al. Incidence of occult rectal prolapse in patients with clinical rectoceles and defecatory dysfunction. Am J Obstet Gynecol. 2002;187:1494-1500.
  7. Jallad K, Gurland B. Multidisciplinary approach to the treatment of concomitant rectal and vaginal prolapse. Clin Colon Rectal Surg. 2016;29:101-105.
  8. Kapoor DS, Sultan AH, Thakar R, et al. Management of complex pelvic floor disorders in a multidisciplinary pelvic floor clinic. Colorectal Dis. 2008;10:118-123.
  9. Weinberg D, Qeadan F, McKee R, et al. Safety of laparoscopic sacrocolpopexy with concurrent rectopexy: peri-operative morbidity in a nationwide cohort. Int Urogynecol J. 2019;30:385-392.
  10. Geltzeiler CB, Birnbaum EH, Silviera ML, et al. Combined rectopexy and sacrocolpopexy is safe for correction of pelvic organ prolapse. Int J Colorectal Dis. 2018;33:1453-1459.
  11. Wallace SL, Syan R, Enemchukwu EA, et al. Surgical approach, complications, and reoperation rates of combined rectal and pelvic organ prolapse surgery. Int Urogynecol J. 2020;31:2101-2108.
  12. Smith PE, Hade EM, Pandya LK, et al. Perioperative outcomes for combined ventral rectopexy with sacrocolpopexy compared to perineal rectopexy with vaginal apical suspension. Female Pelvic Med Reconstr Surg. 2020;26:376-381.
  13. Casas-Puig V, Bretschneider CE, Ferrando CA. Perioperative adverse events in women undergoing concurrent hemorrhoidectomy at the time of urogynecologic surgery. Female Pelvic Med Reconstr Surg. 2019;25:88-92.
  14. Cordeiro PG, Pusic AL, Disa JJ. A classification system and reconstructive algorithm for acquired vaginal defects. Plast Reconstr Surg. 2002;110:1058-1065.
  15. Lewicky-Gaupp C, Leader-Cramer A, Johnson LL, et al. Wound complications after obstetric anal sphincter injuries. Obstet Gynecol. 2015;125:1088-1093.
  16. Borello-France D, Burgio KL, Richter HE, et al; Pelvic Floor Disorders Network. Fecal and urinary incontinence in primiparous women. Obstet Gynecol. 2006;108:863-872.
  17. Propst K, Hickman LC. Peripartum pelvic floor disorder clinics inform obstetric provider practices. Int Urogynecol J. 2021;32:1793-1799.
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Dismantling racism in your personal and professional spheres

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Fri, 09/24/2021 - 15:29

On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.1 People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

 

 

What is racism, and who is racist?

Various definitions of racism have been offered:

  • prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized2
  • a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race3
  • the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.3

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”4 This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.4

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”4 He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”4 In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.5 The ability to assign market value to a Black person’s body was published as an essential physician competency.5

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.6 Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.6 Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”9

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.10 These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.8,11

Continue to: Health disparities...

 

 

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.12

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.13 In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.14 These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.15 We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.16 All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.16The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.17 Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.5

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”18 So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.21 This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

 

 

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).22 It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”22 How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.25 Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.25

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

References
  1. Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press: New York, New York; 2012.
  2. Definition of racism in English. Lexico web site. https://www.lexico. com/en/definition/racism. Accessed July 30, 2021.
  3. Definition of racism. Merriam-Webster web site. https://www .merriam-webster.com/dictionary/racism. Accessed July 30, 2021.
  4. Kendi IX. How To Be an Antiracist. One World: New York, NY; 2019.
  5. Cooper Owens D, Fett SM. Black maternal and infant health: historical legacies of slavery. Am J Public Health. 2019;109:1342-1345. doi: 10.2105/AJPH.2019.305243.
  6. Cooper Owens D. Medical Bondage: Race, Gender, and the Origins of American Gynecology. University of Georgia Press: Athens, GA; 2017.
  7. Washington H. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Anchor Books: New York, NY; 2006.
  8. Coates T. The case for reparations. The Atlantic. 2014;313.5:54-71.
  9. Rothstein R. The Color of the Law: A Forgotten History of How our Government Segregated America. Liveright Publishing Corporation: New York, NY; 2017.
  10. Nelson RK, Ayers EL; The Digital Scholarship Lab and the National Community Reinvestment Coalition. American Panorama, ed. Not Even Past: Social Vulnerability and the Legacy of Redlining. https://dsl.richmond.edu/socialvulnerability. Accessed July 30, 2021.
  11. Williams DR, Lawrence JA, Davis BA. Racism and health: evidence and needed research. Annu Rev Public Health. 2019;40:105-125. doi: 10.1146 /annurev-publhealth-040218-043750.
  12. Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Smedley BD, Stith AY, Nelson AR, eds. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. National Academies Press: Washington, DC; 2003.
  13. Artiga S, Corallo B, Pham O. Racial disparities in COVID-19: key findings from available data and analysis. KFF web site. August 17, 2020. https://www.kff.org/racial-equity-and-health-policy/issue-brief /racial-disparities-covid-19-key-findings-available-data-analysis/. Accessed July 30, 2021.
  14. Disparities in deaths from COVID-19. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019-ncov /community/health-equity/racial-ethnic-disparities/disparities -deaths.html. Updated December 10, 2020. Accessed July 30, 2021.
  15. Disparities in COVID-19 hospitalizations. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019 -ncov/community/health-equity/racial-ethnic-disparities/disparities -hospitalization.html. Updated July 28, 2021. Accessed July 30, 2021.
  16. COVID data tracker. Centers for Disease Control and Prevention web site. https://covid.cdc.gov/covid-data-tracker/#vaccination -demographics-trends. Accessed July 30, 2021.
  17. Infant mortality. Centers for Disease Control and Prevention web site. https://www.cdc.gov/reproductivehealth/maternalinfanthealth /infantmortality.htm. Last reviewed September 2020. Accessed July 30, 2021.
  18. Roeder A. America is failing its Black mothers. Harvard Public Health. Winter 2019. https://www.hsph.harvard.edu/magazine/magazine _article/america-is-failing-its-black-mothers/. Accessed July 30, 2021.
  19. Ku E, Lee BK, McCulloch CE, et al. Racial and ethnic disparities in kidney transplant access within a theoretical context of medical eligibility. Transplantation. 2020;104:1437-1444. doi: 10.1097/TP .0000000000002962.
  20. Arya S, Binney Z, Khakharia A, et al. Race and socioeconomic status independently affect risk of major amputation in peripheral artery disease. J Am Heart Assoc. 2018;7:e007425. doi: 10.1161 /JAHA.117.007425.
  21. Vyas DA, Eisenstein LG, Jones DS, et al. Hidden in plain sight— reconsidering the use of race correction in clinical algorithms. N Engl J Med. 2020;383:874-882. doi: 10.1056/NEJMms2004740.
  22. A Curriculum to Increase Faculty Engagement in the CLER Program. Boston University Medical Center web site. https://www.bumc .bu.edu/facdev-medicine/files/2020/05/Bystander-Training-for -Microaggressions-Executive-Summary.pdf. Accessed July 30, 2021.
  23. Brenè with Aiko Bethea on inclusivity at work: the heart of hard conversations. Spotify web site. https://open.spotify.com/episod e/3IODQ37EurkFf0zMNhazqI?si=wJIZgzpWTDCF1QVhwAdhiw. Accessed July 30, 2021.
  24. Brenè with Aiko Bethea on creating transformative cultures. Spotify web site. https://open.spotify.com/episode/7K47gQF5Ruc7MAXxEN q6jI?si=X0pzd2NnRAGwMD-bkyg-VQ. Accessed July 30, 2021.
  25. Bethea A. An open letter to corporate America, philanthropy, academia, etc.: What now? June 1, 2020. https://aikobethea.medium. com/an-open-letter-to-corporate-america-philanthropy-academiaetc-what-now-8b2d3a310f22. Accessed July 30, 2021.
  26. Choo E. Seven things organisations should be doing to combat racism. Lancet. 2020;396:157. doi:10.1016/S0140-6736(20)31565-8.
  27. Olayiwola JN, Choo E. Seven more things organisations should be doing to combat racism. Lancet. 2020;396:593. doi: 10.1016/S0140 -6736(20)31718-9.
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Author and Disclosure Information

Dr. Carberry is Associate Professor, Clinician Educator, of Ob/Gyn, Alpert Medical School of Brown University. She completed the Brown Advocates for Social Change and Equity Fellowship and is a Member, Brown task force to redesign medical school core competency to focus on racial justice; Brown task force for sex and gender inclusivity; Diversity, Equity, and Inclusion Committee, Department of Ob/Gyn; and AUGS Diversity and Inclusion Task Force.

Dr. Madsen is a global women’s health advocate engaged in international medicine and service.

Dr. Cardenas-Trowers is involved in several local and national organizations that mentor underrepresented minoritized (URM) individuals, particularly those interested in careers in medicine. She served as an invited speaker and panelist for the 2019 Student National Medical Association Region 10 Medical Education Conference.

Dr. Brown is Member, AUGS Disparities Special Interest Group and Diversity and Inclusion Task Force. 

Dr. Siddique is Member, AUGS Disparities Special Interest Group. 

Dr. Washington is Clinical Associate Professor, Elson S. Floyd College of Medicine at Washington State University; Chair, Inclusion, Diversity, Equity, Accessibility, and Sensitivity Committee at MCG Health; Collaborator in an award-winning STEAM program for URM middle and high school girls; and a global women’s health advocate engaged in international medicine and service.

The authors report no financial relationships relevant to this article.

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Author and Disclosure Information

Dr. Carberry is Associate Professor, Clinician Educator, of Ob/Gyn, Alpert Medical School of Brown University. She completed the Brown Advocates for Social Change and Equity Fellowship and is a Member, Brown task force to redesign medical school core competency to focus on racial justice; Brown task force for sex and gender inclusivity; Diversity, Equity, and Inclusion Committee, Department of Ob/Gyn; and AUGS Diversity and Inclusion Task Force.

Dr. Madsen is a global women’s health advocate engaged in international medicine and service.

Dr. Cardenas-Trowers is involved in several local and national organizations that mentor underrepresented minoritized (URM) individuals, particularly those interested in careers in medicine. She served as an invited speaker and panelist for the 2019 Student National Medical Association Region 10 Medical Education Conference.

Dr. Brown is Member, AUGS Disparities Special Interest Group and Diversity and Inclusion Task Force. 

Dr. Siddique is Member, AUGS Disparities Special Interest Group. 

Dr. Washington is Clinical Associate Professor, Elson S. Floyd College of Medicine at Washington State University; Chair, Inclusion, Diversity, Equity, Accessibility, and Sensitivity Committee at MCG Health; Collaborator in an award-winning STEAM program for URM middle and high school girls; and a global women’s health advocate engaged in international medicine and service.

The authors report no financial relationships relevant to this article.

Author and Disclosure Information

Dr. Carberry is Associate Professor, Clinician Educator, of Ob/Gyn, Alpert Medical School of Brown University. She completed the Brown Advocates for Social Change and Equity Fellowship and is a Member, Brown task force to redesign medical school core competency to focus on racial justice; Brown task force for sex and gender inclusivity; Diversity, Equity, and Inclusion Committee, Department of Ob/Gyn; and AUGS Diversity and Inclusion Task Force.

Dr. Madsen is a global women’s health advocate engaged in international medicine and service.

Dr. Cardenas-Trowers is involved in several local and national organizations that mentor underrepresented minoritized (URM) individuals, particularly those interested in careers in medicine. She served as an invited speaker and panelist for the 2019 Student National Medical Association Region 10 Medical Education Conference.

Dr. Brown is Member, AUGS Disparities Special Interest Group and Diversity and Inclusion Task Force. 

Dr. Siddique is Member, AUGS Disparities Special Interest Group. 

Dr. Washington is Clinical Associate Professor, Elson S. Floyd College of Medicine at Washington State University; Chair, Inclusion, Diversity, Equity, Accessibility, and Sensitivity Committee at MCG Health; Collaborator in an award-winning STEAM program for URM middle and high school girls; and a global women’s health advocate engaged in international medicine and service.

The authors report no financial relationships relevant to this article.

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On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.1 People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

 

 

What is racism, and who is racist?

Various definitions of racism have been offered:

  • prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized2
  • a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race3
  • the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.3

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”4 This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.4

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”4 He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”4 In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.5 The ability to assign market value to a Black person’s body was published as an essential physician competency.5

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.6 Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.6 Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”9

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.10 These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.8,11

Continue to: Health disparities...

 

 

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.12

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.13 In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.14 These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.15 We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.16 All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.16The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.17 Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.5

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”18 So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.21 This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

 

 

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).22 It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”22 How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.25 Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.25

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

On May 25, 2020, George Floyd was murdered by a White police officer who held his knee on Floyd’s neck for nine and a half minutes. Nine and a half minutes. George Floyd was not the first Black person killed by law enforcement. He has not been the last. Much has been written about why Floyd’s murder sparked unprecedented worldwide outrage despite being far from unprecedented itself. We cannot be so naive as to think what happened was new, and we should not ignore the tireless work that so many have been doing to fight racism up to this point. But for many who have been stirred to do something for the first time, especially White people, the question has been,

“What do I do?” The answer is, do the work.

This article is centered on anti-Black racism with a focus on medicine. We recognize that there is racism against other minoritized groups. Each group deserves attention and to have their stories told. We recognize intersectionality and that an individual has multiple identities and that these may compound the marginalization they experience. This too deserves attention.

However, we cannot satisfactorily explore any of these concepts within the confines of a single article. Our intention is to use this forum to promote further conversation, specifically about anti-Black racism in medicine. We hope it compels you to begin learning to recognize and dismantle racism in yourself and your surroundings, both at home and at work.

Being a health care provider requires lifelong learning. If we practiced only what we learned in training, our patients could suffer. So we continually seek out updated research and guidelines to best treat our patients. Understanding how racism impacts your patients, colleagues, family, and friends is your responsibility as much as understanding guidelines for standards of care. We must resist the urge to feel this is someone else’s duty. It is the job of each and every one of us. We must do the work.

Race is real but it’s not biologic

It is imperative to understand that race is not a biologic category. Phenotypic differences between humans do not reliably map to racial categories. Racial categories themselves have morphed over the centuries, and interpretation of race has been litigated in this country since its founding.1 People who identify as a given race do not have inherent biology that is different from those who identify as another race. It may then be tempting to try to erase race from our thinking, and, indeed, the idea of being “color blind” was long worn as a badge of honor signifying a commitment to equality. So this is the tension: if race exists, it must be a biologic trait and with it must go other inherent traits. But if race is not a biologic entity, perhaps it is not real and, therefore, should be ignored. In fact, neither is true. Race is not based on genetic or biologic inheritance, but it is a social and political categorization that is real and has very real ramifications. As we will discuss further, race does have a biologic impact on individuals. The mechanism by which that happens is racism.

Continue to: What is racism, and who is racist?...

 

 

What is racism, and who is racist?

Various definitions of racism have been offered:

  • prejudice, discrimination, or antagonism directed against a person or people on the basis of their membership in a particular racial or ethnic group, typically one that is minoritized or marginalized2
  • a belief that race is a fundamental determinant of human traits and capacities and that racial differences produce an inherent superiority of a particular race3
  • the systemic oppression of a racial group to the social, economic, and political advantage of another; a political or social system founded on racism and designed to execute its principles.3

The common themes in these definitions are power, hierarchy, and oppression. Racism is a fabricated system to justify and reinforce power for some and disenfranchisement for others based on race. The system is pervasive and beneficial to the group that it serves.

Ibram X. Kendi posits that all racism is structural racism: “‘Institutional racism’ and ‘structural racism’ and ‘systemic racism’ are redundant. Racism itself is institutional, structural, and systemic.”4 This is not saying that individuals don’t enact racism, but it emphasizes that racism is not the action of a “few bad apples.” Furthermore, it underscores that race was created to bolster power structures ensuring White dominance. The racism that has followed, in all of its forms, is both because these ideas were created in the first place and to perpetuate that ongoing power structure.4

Dorothy Roberts, JD, writes in her book Fatal Invention that, while grouping people and creating hierarchy has always happened amongst humans, there is a specific history in our country of using race to create and perpetuate the dominance of White people and the subjugation of Black people.

Kendi also asserts that there is no neutrality with regard to racism—there is racist and antiracist: “A racist: one who is supporting a racist policy through their actions or inaction or expressing a racist idea. An antiracist: one who is supporting an antiracist policy through their actions or expressing an antiracist idea.”4 He describes all people as moving in and out of being racist and antiracist, and states “being an antiracist requires persistent self-awareness, constant self-criticism, and regular self-examination.”4 In thinking about race and racism in this way, we all must grapple with our own racism, but in so doing are taking a step toward antiracism.

History is important

Among the most important things one can do in a journey to dismantle racism is learn the history of racism.

The infrastructure and institutions of our nation were created on a foundation of slavery, including the origins of American medicine and gynecology. Physicians in the antebellum South performed inspections of enslaved people’s bodies to certify them for sale.5 The ability to assign market value to a Black person’s body was published as an essential physician competency.5

Gynecology has a particularly painful history with regard to slavery. By 1808, transatlantic slave trade was banned in the United States and, as Dr. Cooper Owens describes in her book Medical Bondage: Race, Gender, and the Origins of American Gynecology, this made reproduction of enslaved people within the United States a priority for slave owners and those invested in an economy that depended on slavery.6 Gynecologists were permitted unrestricted access to enslaved women for experiments to optimize reproduction. Many of these physicians became prominent voices adding to the canon of racialized medicine. Medical journals themselves gained reverence because of heightened interest in keeping enslaved people alive and just well enough to work and reproduce.6 Today, we hold sacred the relationship between a patient and their physician. We must understand that there was no such relationship between a doctor and an enslaved person. The relationship was between the doctor and slave owner.6,7 Slavery does not allow for the autonomy of the enslaved. This is the context in which we must understand the discoveries of gynecologists during that time.

Despite the abolition of slavery with the passage of the 13th amendment, racist policies remained ubiquitous in the United States. Segregation of Black people was codified not only in the Jim Crow South but also in the North. Interracial marriage was outlawed by all but 9 states.

While there are numerous federal policies that led to cumulative and egregious disadvantage for Black Americans, one powerful example is redlining. In 1934 the Federal Housing Administration was created, and by insuring private mortgages, the FHA made it easier for eligible home buyers to obtain financing. The FHA used a system of maps that graded neighborhoods. Racial composition of neighborhoods was overtly used as a component of grading, and the presence of Black people led a neighborhood to be downgraded or redlined.8,9 This meant Black people were largely ineligible for FHA-backed loans. In The Color of Law, Richard Rothstein writes, “Today’s residential segregation in the North, South, Midwest, and West is not the unintended consequence of individual choices and of otherwise well-meaning law or regulation but of unhidden public policy that explicitly segregated every metropolitan area in the United States.The policy was so systematic and forceful that its effects endure to the present time.”9

Though these specific policies are no longer in place, many correlations have been found between historically redlined neighborhoods and higher rates of diseases today, including diabetes, hypertension, asthma, and preterm deliveries.10 These policies also have played a role in creating the wealth gap—directly by limiting the opportunity for home ownership, which translates to intergenerational wealth, and indirectly by the disinvestment in neighborhoods where Black people live, leading to reduced access to quality education, decreased employment opportunities, and increased environmental hazards.8,11

Continue to: Health disparities...

 

 

Health disparities

The numerous health disparities, more accurately termed health inequities, suffered by racial minority groups is well documented.12

COVID-19 death and vaccination-rate inequities. Early in the COVID-19 pandemic, data emerged that racial minorities were being disparately affected.13 In December 2020, the Centers for Disease Control and Prevention (CDC) reported that Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people had all died at higher rates than White Americans.14 These racial groups had higher hospitalization rates across age groups and, after adjusting for age, rates of hospitalization were 2.8 to 3.4 times higher.15 We are continuing to learn what factors contribute to these inequities, but it has highlighted how racist policies have led to disparate access to health care, or even clean air, clean water, and nutritious food, and left communities of color more vulnerable to severe illness and death from COVID-19. With the advent of vaccines for COVID-19, we continue to see racial disparities as Black Americans have the lowest rates of vaccination.16 All of these inequities have to be understood in the context of the racist structures that exist in our society. As medical providers, we must understand and help to dismantle these structures.

Pregnancy-related mortality (PRM) inequities. A powerful example of a persistent health inequity in our field is the well-known disparity in pregnancy-related mortality when examining this outcome by race. Per CDC analysis of data on PRM from 2007–2016, Black women died at a rate 3.2 times higher than White women. This disparity was even greater in patients older than 30 years of age. When they compared rates while controlling for the highest level of education, the disparity is even more pronounced: PRM rate for those with a college degree or higher was 5.2 times greater for Black people compared with White people.16The CDC also reported that, in 2018, the infant mortality for non-Hispanic Black infants was 10.8 per 1,000 live births, compared with 4.6 per 1,000 live births for White infants. This is a rate 2.4-times higher for Black infants.17 Dr. Cooper Owens and Dr. Fett note in their article, “Black maternal and infant health: Historical legacies of slavery,” that in 1850 this rate was 1.6-times higher for Black infants, which means the inequity was worse in 2018 America than in the antebellum South.5

The role of patient experience

As discussed, governmental policies have created persistent inequities in wealth, access to health care, and exposure to environmental toxins, among many other disparities. However, the data finding that highly educated Black pregnant patients suffer markedly increased risk of maternal death, indicate that inequities cannot be attributed only to education or lack of access to health care. This is where some will once again lean on the idea that there is something inherently different about Black people. But if we know that race was created and is not an empiric category, we must consider the social variables impacting Black patients’ experience.

As Linda Blount, President and CEO of the Black Women’s Health Imperative, put it, “Race is not a risk factor. It is the lived experience of being a Black woman in this society that is the risk factor.”18 So how much of these inequities can be accounted for by differential treatment of Black patients? There is, for example, data on the disproportionately lower rates of Black renal transplant recipients and inordinately higher rates of amputations among Black patients.19,20 None of us wants to think we are treating our Black patients differently, but the data demand that we ask ourselves if we are. Some of this is built into the system. For example, in their article “Hidden in plain sight—Reconsidering the use of race correction in clinical algorithms,” Vyas and colleagues outline a list of calculators and algorithms that include race.21 This means we may be using these calculators and changing outcomes for our patients based on their race. This is only one example of racism hidden within guidelines and standards of care.

The existence of racism on an interpersonal level also cannot be denied. This could lead to differential care specifically, but also can manifest by way of the toll it takes on a patient generally. This is the concept of allostatic load or weathering: the chronic stress of experiencing racism creates detrimental physiologic change. There is ongoing research into epigenetic modifications from stress that could be impacting health outcomes in Black populations.

Continue to: What is the work we need to do?...

 

 

What is the work we need to do?

Become educated. We have discussed taking the initiative to learn about the history of racism, including the legacies of slavery and the ongoing impact of racism on health. This knowledge is foundational and sometimes transformative. It allows us to see opportunities for antiracism and gives us the knowledge to begin meaningful conversations.

Take action. We must take inventory within our lives. What are our spheres of influence? What are our resources? Where can we make an impact? Right now, you can take out a pen and paper and write down all the roles you play. Look for opportunities in personal interactions and daily routines. Unfortunately, there will be many opportunities to speak up against racism—although this is rarely easy. Find articles, podcasts, and workshops on upstander training. One framework to respond to microaggressions has been proposed by faculty at Boston University Medical Center using the acronym LIFT (Lights on, Impact vs Intent, Full stop, Teach).22 It advises highlighting, clarifying, and directly addressing problematic comments with such statements as “I heard you say…” or “What did you mean by that comment?”, or a more direct “Statements like that are not OK with me,” or a teaching statement of “I read an article that made me think differently about comments like the one you made...”22 How and when to employ these strategies takes deliberate practice and will be uncomfortable. But we must do the work.

Practice empathetic listening. In a podcast discussion with Brené Brown on creating transformative cultures, Aiko Bethea, a leader in diversity and equity innovation, implores listeners to believe people of color.23,24 Draw on the history you’ve learned and understand the context in which Black people live in our society. Don’t brush off your Black friend who is upset about being stopped by security. That wasn’t the first time she was in that situation. Take seriously your patient’s concern that they are not being treated appropriately because of being Black. At the same time, do not think of Black people as a monolith or a stereotype. Respect people’s individuality.

Teach our kids all of this. We must also find ways to make change on a larger scale—within our practices, hospitals, medical schools, places of worship, town councils, school boards, state legislatures, and so on. If you are in a faculty position, you can reach out to leadership to scrutinize the curriculum while also ensuring that what and how you are teaching aligns with your antiracist principles. Question the theories, calculators, and algorithms being used and taught. Inquire about policies around recruitment of trainees and faculty as well as promotion, and implement strategies to make this inclusive and equitable. If you run a practice, you can ensure hiring and compensation policies are equitable. Examine patient access and barriers that your minoritized patients are facing, and address those barriers. Share resources and tools that you find helpful and develop a community of colleagues to develop with and hold one another accountable.

In her June 2020 article, An Open Letter to Corporate America, Philanthropy, Academia, etc: What now?, Bethea lays out an extensive framework for approaching antiracism at a high level.25 Among the principles she emphasizes is that the work of diversity, equity, and inclusion should not be siloed and cannot continue to be undervalued. It must be viewed as leadership and engaged in by leadership. The work of diversity, equity, and inclusion for any given institution must be explicit, intentional, measured, and transparent. Within that work, antiracism deserves individual attention. This work must center the people of color for whom you are pursuing equity. White people must resist the urge to make this about them.25

Drs. Esther Choo and J. Nwando Olayiwola present their proposals for combating racism in two 2020 Lancet articles.26,27 They discuss anticipating failure and backlash and learning from them but not being derailed by them. They emphasize the need for ongoing, serious financial investment and transformation in leadership. They also point out the need for data, discouraging more research on well-established inequities while recommending investigating interventions.26,27 If you are in leadership positions, read these articles and many more. Enact these principles. Make the investment. If you are not in such a position, find ways to hold your organization’s leadership accountable. Find ways to get a seat at the table and steer the conversation. In medicine, we have to make change at every level of our organizations. That will include the very difficult work of changing climate and culture. In addition, we have to look not only within our organizations but also to the communities we serve. Those voices must be valued in this conversation.

Will this take time? Yes. Will this be hard? Yes. Can you do everything? No. Can you do your part? Yes! Do the work. 

References
  1. Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press: New York, New York; 2012.
  2. Definition of racism in English. Lexico web site. https://www.lexico. com/en/definition/racism. Accessed July 30, 2021.
  3. Definition of racism. Merriam-Webster web site. https://www .merriam-webster.com/dictionary/racism. Accessed July 30, 2021.
  4. Kendi IX. How To Be an Antiracist. One World: New York, NY; 2019.
  5. Cooper Owens D, Fett SM. Black maternal and infant health: historical legacies of slavery. Am J Public Health. 2019;109:1342-1345. doi: 10.2105/AJPH.2019.305243.
  6. Cooper Owens D. Medical Bondage: Race, Gender, and the Origins of American Gynecology. University of Georgia Press: Athens, GA; 2017.
  7. Washington H. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Anchor Books: New York, NY; 2006.
  8. Coates T. The case for reparations. The Atlantic. 2014;313.5:54-71.
  9. Rothstein R. The Color of the Law: A Forgotten History of How our Government Segregated America. Liveright Publishing Corporation: New York, NY; 2017.
  10. Nelson RK, Ayers EL; The Digital Scholarship Lab and the National Community Reinvestment Coalition. American Panorama, ed. Not Even Past: Social Vulnerability and the Legacy of Redlining. https://dsl.richmond.edu/socialvulnerability. Accessed July 30, 2021.
  11. Williams DR, Lawrence JA, Davis BA. Racism and health: evidence and needed research. Annu Rev Public Health. 2019;40:105-125. doi: 10.1146 /annurev-publhealth-040218-043750.
  12. Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Smedley BD, Stith AY, Nelson AR, eds. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. National Academies Press: Washington, DC; 2003.
  13. Artiga S, Corallo B, Pham O. Racial disparities in COVID-19: key findings from available data and analysis. KFF web site. August 17, 2020. https://www.kff.org/racial-equity-and-health-policy/issue-brief /racial-disparities-covid-19-key-findings-available-data-analysis/. Accessed July 30, 2021.
  14. Disparities in deaths from COVID-19. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019-ncov /community/health-equity/racial-ethnic-disparities/disparities -deaths.html. Updated December 10, 2020. Accessed July 30, 2021.
  15. Disparities in COVID-19 hospitalizations. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019 -ncov/community/health-equity/racial-ethnic-disparities/disparities -hospitalization.html. Updated July 28, 2021. Accessed July 30, 2021.
  16. COVID data tracker. Centers for Disease Control and Prevention web site. https://covid.cdc.gov/covid-data-tracker/#vaccination -demographics-trends. Accessed July 30, 2021.
  17. Infant mortality. Centers for Disease Control and Prevention web site. https://www.cdc.gov/reproductivehealth/maternalinfanthealth /infantmortality.htm. Last reviewed September 2020. Accessed July 30, 2021.
  18. Roeder A. America is failing its Black mothers. Harvard Public Health. Winter 2019. https://www.hsph.harvard.edu/magazine/magazine _article/america-is-failing-its-black-mothers/. Accessed July 30, 2021.
  19. Ku E, Lee BK, McCulloch CE, et al. Racial and ethnic disparities in kidney transplant access within a theoretical context of medical eligibility. Transplantation. 2020;104:1437-1444. doi: 10.1097/TP .0000000000002962.
  20. Arya S, Binney Z, Khakharia A, et al. Race and socioeconomic status independently affect risk of major amputation in peripheral artery disease. J Am Heart Assoc. 2018;7:e007425. doi: 10.1161 /JAHA.117.007425.
  21. Vyas DA, Eisenstein LG, Jones DS, et al. Hidden in plain sight— reconsidering the use of race correction in clinical algorithms. N Engl J Med. 2020;383:874-882. doi: 10.1056/NEJMms2004740.
  22. A Curriculum to Increase Faculty Engagement in the CLER Program. Boston University Medical Center web site. https://www.bumc .bu.edu/facdev-medicine/files/2020/05/Bystander-Training-for -Microaggressions-Executive-Summary.pdf. Accessed July 30, 2021.
  23. Brenè with Aiko Bethea on inclusivity at work: the heart of hard conversations. Spotify web site. https://open.spotify.com/episod e/3IODQ37EurkFf0zMNhazqI?si=wJIZgzpWTDCF1QVhwAdhiw. Accessed July 30, 2021.
  24. Brenè with Aiko Bethea on creating transformative cultures. Spotify web site. https://open.spotify.com/episode/7K47gQF5Ruc7MAXxEN q6jI?si=X0pzd2NnRAGwMD-bkyg-VQ. Accessed July 30, 2021.
  25. Bethea A. An open letter to corporate America, philanthropy, academia, etc.: What now? June 1, 2020. https://aikobethea.medium. com/an-open-letter-to-corporate-america-philanthropy-academiaetc-what-now-8b2d3a310f22. Accessed July 30, 2021.
  26. Choo E. Seven things organisations should be doing to combat racism. Lancet. 2020;396:157. doi:10.1016/S0140-6736(20)31565-8.
  27. Olayiwola JN, Choo E. Seven more things organisations should be doing to combat racism. Lancet. 2020;396:593. doi: 10.1016/S0140 -6736(20)31718-9.
References
  1. Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press: New York, New York; 2012.
  2. Definition of racism in English. Lexico web site. https://www.lexico. com/en/definition/racism. Accessed July 30, 2021.
  3. Definition of racism. Merriam-Webster web site. https://www .merriam-webster.com/dictionary/racism. Accessed July 30, 2021.
  4. Kendi IX. How To Be an Antiracist. One World: New York, NY; 2019.
  5. Cooper Owens D, Fett SM. Black maternal and infant health: historical legacies of slavery. Am J Public Health. 2019;109:1342-1345. doi: 10.2105/AJPH.2019.305243.
  6. Cooper Owens D. Medical Bondage: Race, Gender, and the Origins of American Gynecology. University of Georgia Press: Athens, GA; 2017.
  7. Washington H. Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present. Anchor Books: New York, NY; 2006.
  8. Coates T. The case for reparations. The Atlantic. 2014;313.5:54-71.
  9. Rothstein R. The Color of the Law: A Forgotten History of How our Government Segregated America. Liveright Publishing Corporation: New York, NY; 2017.
  10. Nelson RK, Ayers EL; The Digital Scholarship Lab and the National Community Reinvestment Coalition. American Panorama, ed. Not Even Past: Social Vulnerability and the Legacy of Redlining. https://dsl.richmond.edu/socialvulnerability. Accessed July 30, 2021.
  11. Williams DR, Lawrence JA, Davis BA. Racism and health: evidence and needed research. Annu Rev Public Health. 2019;40:105-125. doi: 10.1146 /annurev-publhealth-040218-043750.
  12. Institute of Medicine (US) Committee on Understanding and Eliminating Racial and Ethnic Disparities in Health Care. Smedley BD, Stith AY, Nelson AR, eds. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. National Academies Press: Washington, DC; 2003.
  13. Artiga S, Corallo B, Pham O. Racial disparities in COVID-19: key findings from available data and analysis. KFF web site. August 17, 2020. https://www.kff.org/racial-equity-and-health-policy/issue-brief /racial-disparities-covid-19-key-findings-available-data-analysis/. Accessed July 30, 2021.
  14. Disparities in deaths from COVID-19. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019-ncov /community/health-equity/racial-ethnic-disparities/disparities -deaths.html. Updated December 10, 2020. Accessed July 30, 2021.
  15. Disparities in COVID-19 hospitalizations. Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019 -ncov/community/health-equity/racial-ethnic-disparities/disparities -hospitalization.html. Updated July 28, 2021. Accessed July 30, 2021.
  16. COVID data tracker. Centers for Disease Control and Prevention web site. https://covid.cdc.gov/covid-data-tracker/#vaccination -demographics-trends. Accessed July 30, 2021.
  17. Infant mortality. Centers for Disease Control and Prevention web site. https://www.cdc.gov/reproductivehealth/maternalinfanthealth /infantmortality.htm. Last reviewed September 2020. Accessed July 30, 2021.
  18. Roeder A. America is failing its Black mothers. Harvard Public Health. Winter 2019. https://www.hsph.harvard.edu/magazine/magazine _article/america-is-failing-its-black-mothers/. Accessed July 30, 2021.
  19. Ku E, Lee BK, McCulloch CE, et al. Racial and ethnic disparities in kidney transplant access within a theoretical context of medical eligibility. Transplantation. 2020;104:1437-1444. doi: 10.1097/TP .0000000000002962.
  20. Arya S, Binney Z, Khakharia A, et al. Race and socioeconomic status independently affect risk of major amputation in peripheral artery disease. J Am Heart Assoc. 2018;7:e007425. doi: 10.1161 /JAHA.117.007425.
  21. Vyas DA, Eisenstein LG, Jones DS, et al. Hidden in plain sight— reconsidering the use of race correction in clinical algorithms. N Engl J Med. 2020;383:874-882. doi: 10.1056/NEJMms2004740.
  22. A Curriculum to Increase Faculty Engagement in the CLER Program. Boston University Medical Center web site. https://www.bumc .bu.edu/facdev-medicine/files/2020/05/Bystander-Training-for -Microaggressions-Executive-Summary.pdf. Accessed July 30, 2021.
  23. Brenè with Aiko Bethea on inclusivity at work: the heart of hard conversations. Spotify web site. https://open.spotify.com/episod e/3IODQ37EurkFf0zMNhazqI?si=wJIZgzpWTDCF1QVhwAdhiw. Accessed July 30, 2021.
  24. Brenè with Aiko Bethea on creating transformative cultures. Spotify web site. https://open.spotify.com/episode/7K47gQF5Ruc7MAXxEN q6jI?si=X0pzd2NnRAGwMD-bkyg-VQ. Accessed July 30, 2021.
  25. Bethea A. An open letter to corporate America, philanthropy, academia, etc.: What now? June 1, 2020. https://aikobethea.medium. com/an-open-letter-to-corporate-america-philanthropy-academiaetc-what-now-8b2d3a310f22. Accessed July 30, 2021.
  26. Choo E. Seven things organisations should be doing to combat racism. Lancet. 2020;396:157. doi:10.1016/S0140-6736(20)31565-8.
  27. Olayiwola JN, Choo E. Seven more things organisations should be doing to combat racism. Lancet. 2020;396:593. doi: 10.1016/S0140 -6736(20)31718-9.
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Vaginal surgery: Don’t get bent out of shape

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Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

 

 

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).1

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.2 However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.2

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.3 Energy type had no effect on reproductive outcomes in either group.3

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

 

 

How does the resectoscope compare with mechanical tissue removal systems?

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.4-8 However, studies have found no significant difference in postoperative patient satisfaction.7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.10

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

  • bow-and-arrow technique
  • identification of the fibroid anatomy (pseudocapsule plane)
  • blunt cold loop dissection
  • the push-and-tuck method
  • efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

 

 

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

References
  1. Berg A, Sandvik L, Langebrekke A, et al. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009;91:1273- 1278.
  2. Roy KK, Metta S, Kansal Y, et al. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women. J Hum Reprod Sci. 2017;10:185-193.
  3. Roy KK, Kansal Y, Subbaiah M, et al. Hysteroscopic septal resection using unipolar resectoscope versus bipolar resectoscope: prospective, randomized study. J Obstet Gynaecol Res. 2015;41:952-956.
  4. Borg MH, Shehata A. Uterine morcellator versus resectoscopy in the management of heavy menstrual flow in reproductiveage women. J Gyn Res. 2016;2:1-8.
  5. Emanuel MH, Wamsteker K. The intra uterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005;12:62-66.
  6. Smith PP, Middleton LJ, Connor M, et al. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014;123:745-751.
  7. Vitale SG, Sapia F, Rapisarda AMC, et al. Hysteroscopic morcellation of submucous myomas: a systematic review. Biomed Res Int. 2017;2017:6848250.
  8. Stoll F, Lecointre L, Meyer N, et al. Randomized study comparing a reusable morcellator with a resectoscope in the hysteroscopic treatment of uterine polyps: the RESMO study. J Minimal Invasive Gyn. 2021;28:801-810.
  9. Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016;22:56-61.
  10. van Dongen H, Emanuel MH, Wolterbeek R, et al. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008;15:466-471.
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Dr. Hur reports receiving honorarium from UpToDate, Inc. Dr. Sia reports no financial relationships relevant to this article.

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Dr. Hur reports receiving honorarium from UpToDate, Inc. Dr. Sia reports no financial relationships relevant to this article.

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Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

 

 

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).1

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.2 However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.2

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.3 Energy type had no effect on reproductive outcomes in either group.3

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

 

 

How does the resectoscope compare with mechanical tissue removal systems?

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.4-8 However, studies have found no significant difference in postoperative patient satisfaction.7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.10

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

  • bow-and-arrow technique
  • identification of the fibroid anatomy (pseudocapsule plane)
  • blunt cold loop dissection
  • the push-and-tuck method
  • efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

 

 

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

 

 

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).1

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.2 However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.2

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.3 Energy type had no effect on reproductive outcomes in either group.3

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

 

 

How does the resectoscope compare with mechanical tissue removal systems?

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.4-8 However, studies have found no significant difference in postoperative patient satisfaction.7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.10

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

  • bow-and-arrow technique
  • identification of the fibroid anatomy (pseudocapsule plane)
  • blunt cold loop dissection
  • the push-and-tuck method
  • efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

 

 

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

References
  1. Berg A, Sandvik L, Langebrekke A, et al. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009;91:1273- 1278.
  2. Roy KK, Metta S, Kansal Y, et al. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women. J Hum Reprod Sci. 2017;10:185-193.
  3. Roy KK, Kansal Y, Subbaiah M, et al. Hysteroscopic septal resection using unipolar resectoscope versus bipolar resectoscope: prospective, randomized study. J Obstet Gynaecol Res. 2015;41:952-956.
  4. Borg MH, Shehata A. Uterine morcellator versus resectoscopy in the management of heavy menstrual flow in reproductiveage women. J Gyn Res. 2016;2:1-8.
  5. Emanuel MH, Wamsteker K. The intra uterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005;12:62-66.
  6. Smith PP, Middleton LJ, Connor M, et al. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014;123:745-751.
  7. Vitale SG, Sapia F, Rapisarda AMC, et al. Hysteroscopic morcellation of submucous myomas: a systematic review. Biomed Res Int. 2017;2017:6848250.
  8. Stoll F, Lecointre L, Meyer N, et al. Randomized study comparing a reusable morcellator with a resectoscope in the hysteroscopic treatment of uterine polyps: the RESMO study. J Minimal Invasive Gyn. 2021;28:801-810.
  9. Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016;22:56-61.
  10. van Dongen H, Emanuel MH, Wolterbeek R, et al. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008;15:466-471.
References
  1. Berg A, Sandvik L, Langebrekke A, et al. A randomized trial comparing monopolar electrodes using glycine 1.5% with two different types of bipolar electrodes (TCRis, Versapoint) using saline, in hysteroscopic surgery. Fertil Steril. 2009;91:1273- 1278.
  2. Roy KK, Metta S, Kansal Y, et al. A prospective randomized study comparing unipolar versus bipolar hysteroscopic myomectomy in infertile women. J Hum Reprod Sci. 2017;10:185-193.
  3. Roy KK, Kansal Y, Subbaiah M, et al. Hysteroscopic septal resection using unipolar resectoscope versus bipolar resectoscope: prospective, randomized study. J Obstet Gynaecol Res. 2015;41:952-956.
  4. Borg MH, Shehata A. Uterine morcellator versus resectoscopy in the management of heavy menstrual flow in reproductiveage women. J Gyn Res. 2016;2:1-8.
  5. Emanuel MH, Wamsteker K. The intra uterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol. 2005;12:62-66.
  6. Smith PP, Middleton LJ, Connor M, et al. Hysteroscopic morcellation compared with electrical resection of endometrial polyps: a randomized controlled trial. Obstet Gynecol. 2014;123:745-751.
  7. Vitale SG, Sapia F, Rapisarda AMC, et al. Hysteroscopic morcellation of submucous myomas: a systematic review. Biomed Res Int. 2017;2017:6848250.
  8. Stoll F, Lecointre L, Meyer N, et al. Randomized study comparing a reusable morcellator with a resectoscope in the hysteroscopic treatment of uterine polyps: the RESMO study. J Minimal Invasive Gyn. 2021;28:801-810.
  9. Lee MM, Matsuzono T. Hysteroscopic intrauterine morcellation of submucosal fibroids: preliminary results in Hong Kong and comparisons with conventional hysteroscopic monopolar loop resection. Hong Kong Med J. 2016;22:56-61.
  10. van Dongen H, Emanuel MH, Wolterbeek R, et al. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol. 2008;15:466-471.
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Closing the racial gap in minimally invasive gyn hysterectomy and myomectomy

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The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

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Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

Author and Disclosure Information

Dr. Zaritsky is Minimally Invasive Gynecologic Surgeon and Assistant Residency Program Director, Kaiser Permanente Northern California, Oakland Medical Center. 

 

Dr. Ojo is a Chief Resident in Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

Dr. Ritterman Weintraub is Senior Research Project Manager Graduate Medical Education, Kaiser Permanente Northern California. 

 

Dr. Raine-Bennett is Senior Staff Physician and Senior Research Scientist in Division of Research, Obstetrics & Gynecology, Kaiser Permanente Northern California. 

 

The authors report no financial relationships relevant to this article. 

 

 

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.4 Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.5

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.5 According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.6 Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.7 Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.8

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.9 Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.10 A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.11 Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.14 The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.18

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.19 These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,20 calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.21 Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.22

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.23 These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.24

Continue to: How to ensure that BIPOC women get the best management...

 

 

How to ensure that BIPOC women get the best management

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.25 Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.26 Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.8 Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.27 Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.28 It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.29 As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,30 this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.31 Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.32 Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.5 Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;33 therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.34 Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,35 found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).36

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.35 Much work remains to be done for our health care systems to provide equitable care.

References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
References
  1. Ojanuga D. The medical ethics of the ‘father of gynaecology,’ Dr J Marion Sims. J Med Ethics. 1993;19:28-31. doi: 10.1136/jme.19.1.28.
  2. Borrero S, Zite N, Creinin MD. Federally funded sterilization: time to rethink policy? Am J Public Health. 2012;102:1822-1825.
  3. Eaglehouse YL, Georg MW, Shriver CD, et al. Racial differences in time to breast cancer surgery and overall survival in the US Military Health System. JAMA Surg. 2019;154:e185113. doi: 10.1001/jamasurg.2018.5113.
  4. Soliman AM, Yang H, Du EX, et al. The direct and indirect costs of uterine fibroid tumors: a systematic review of the literature between 2000 and 2013. Am J Obstet Gynecol. 2015;213:141-160.
  5. Baird DD, Dunson DB, Hill MC, et al. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188:100-107.
  6. Marshall LM, Spiegelman D, Barbieri RL, et al. Variation in the incidence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90:967-973. doi: 10.1016/s0029-7844(97)00534-6.
  7. Styer AK, Rueda BR. The epidemiology and genetics of uterine leiomyoma. Best Pract Res Clin Obstet Gynaecol. 2016;34:3-12. doi: 10.1016/j.bpobgyn.2015.11.018.
  8. Al-Hendy A, Myers ER, Stewart E. Uterine fibroids: burden and unmet medical need. Semin Reprod Med. 2017;35:473-480. doi: 10.1055/s-0037-1607264.
  9. American College of Obstetricians and Gynecologists. ACOG practice bulletin. Alternatives to hysterectomy in the management of leiomyomas. Obstet Gynecol. 2008;112(2 pt 1):387-400.
  10. Corona LE, Swenson CW, Sheetz KH, et al. Use of other treatments before hysterectomy for benign conditions in a statewide hospital collaborative. Am J Obstet Gynecol. 2015;212:304.e1-e7. doi: 10.1016/j.ajog.2014.11.031.
  11. Nguyen NT, Merchant M, Ritterman Weintraub ML, et al. Alternative treatment utilization before hysterectomy for benign gynecologic conditions at a large integrated health system. J Minim Invasive Gynecol. 2019;26:847-855. doi: 10.1016/j.jmig.2018.08.013.
  12. Laughlin-Tommaso SK, Jacoby VL, Myers ER. Disparities in fibroid incidence, prognosis, and management. Obstet Gynecol Clin North Am. 2017;44:81-94. doi: 10.1016/j.ogc.2016.11.007.
  13. Borah BJ, Laughlin-Tommaso SK, Myers ER, et al. Association between patient characteristics and treatment procedure among patients with uterine leiomyomas. Obstet Gynecol. 2016;127:67-77.
  14. Whiteman MK, Hillis SD, Jamieson DJ, et al. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008;198:34.e1-e7. doi:10.1016/j.ajog.2007.05.039.
  15. Bardens D, Solomayer E, Baum S, et al. The impact of the body mass index (BMI) on laparoscopic hysterectomy for benign disease. Arch Gynecol Obstet. 2014;289:803-807. doi: 10.1007/s00404-013-3050-2.
  16. Seracchioli R, Venturoli S, Vianello F, et al. Total laparoscopic hysterectomy compared with abdominal hysterectomy in the presence of a large uterus. J Am Assoc Gynecol Laparosc. 2002;9:333-338. doi: 10.1016/s1074-3804(05)60413.
  17. Boyd LR, Novetsky AP, Curtin JP. Effect of surgical volume on route of hysterectomy and short-term morbidity. Obstet Gynecol. 2010;116:909-915. doi: 10.1097/AOG.0b013e3181f395d9.
  18. Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a meta-analysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol. 2009;145:14-21. doi: 10.1016/j.ejogrb.2009.03.009.
  19. Wechter ME, Stewart EA, Myers ER, et al. Leiomyoma-related hospitalization and surgery: prevalence and predicted growth based on population trends. Am J Obstet Gynecol. 2011;205:492.e1-e5. doi: 10.1016/j.ajog.2011.07.008.
  20. Bower JK, Schreiner PJ, Sternfeld B, et al. Black-White differences in hysterectomy prevalence: the CARDIA study. Am J Public Health. 2009;99:300-307. doi: 10.2105/AJPH.2008.133702.
  21. Ranjit A, Sharma M, Romano A, et al. Does universal insurance mitigate racial differences in minimally invasive hysterectomy? J Minim Invasive Gynecol. 2017;24. doi:10.1016/j.jmig.2017.03.016.
  22. Pollack LM, Olsen MA, Gehlert SJ, et al. Racial/ethnic disparities/differences in hysterectomy route in women likely eligible for minimally invasive surgery. J Minim Invasive Gynecol. 2020;27:1167-1177.e2. doi:10.1016/j.jmig.2019.09.003.
  23. Stentz NC, Cooney LG, Sammel MD, et al. Association of patient race with surgical practice and perioperative morbidity after myomectomy. Obstet Gynecol. 2018;132:291-297. doi: 10.1097/AOG.0000000000002738.
  24. Roth TM, Gustilo-Ashby T, Barber MD, et al. Effects of race and clinical factors on short-term outcomes of abdominal myomectomy. Obstet Gynecol. 2003;101(5 pt 1):881-884. doi: 10.1016/s0029-7844(03)00015-2.
  25. Bratka S, Diamond JS, Al-Hendy A, et al. The role of vitamin D in uterine fibroid biology. Fertil Steril. 2015;104:698-706. doi: 10.1016/j.fertnstert.2015.05.031.
  26. Ciebiera M, Łukaszuk K, Męczekalski B, et al. Alternative oral agents in prophylaxis and therapy of uterine fibroids—an up-to-date review. Int J Mol Sci. 2017;18:2586. doi:10.3390/ijms18122586.
  27. Hayden EC. Racial bias haunts NIH funding. Nature. 2015;527:145.
  28. Lett LA, Orji WU, Sebro R. Declining racial and ethnic representation in clinical academic medicine: a longitudinal study of 16 US medical specialties. PLoS One. 2018;13:e0207274. doi: 10.1371/journal.pone.0207274.
  29. Sánchez JP, Poll-Hunter N, Stern N, et al. Balancing two cultures: American Indian/Alaska Native medical students’ perceptions of academic medicine careers. J Community Health. 2016;41:871-880.
  30. Rayburn WF, Xierali IM, Castillo-Page L, et al. Racial and ethnic differences between obstetrician-gynecologists and other adult medical specialists. Obstet Gynecol. 2016;127:148-152. doi: 10.1097/AOG.0000000000001184.
  31. Esters D, Xierali IM, Nivet MA, et al. The rise of nontenured faculty in obstetrics and gynecology by sex and underrepresented in medicine status. Obstet Gynecol. 2019;134 suppl 1:34S-39S. doi: 10.1097/AOG.0000000000003484.
  32. Ly DP, Seabury SA, Jena AB. Differences in incomes of physicians in the United States by race and sex: observational study. BMJ. 2016;I2923. doi:10.1136/bmj.i2923.
  33. Groff JY, Mullen PD, Byrd T, et al. Decision making, beliefs, and attitudes toward hysterectomy: a focus group study with medically underserved women in Texas. J Womens Health Gend Based Med. 2000;9 suppl 2:S39-50. doi: 10.1089/152460900318759.
  34. Andryjowicz E, Wray T. Regional expansion of minimally invasive surgery for hysterectomy: implementation and methodology in a large multispecialty group. Perm J. 2011;15:42-46.
  35. Zaritsky E, Ojo A, Tucker LY, et al. Racial disparities in route of hysterectomy for benign indications within an integrated health care system. JAMA Netw Open. 2019;2:e1917004. doi: 10.1001/jamanetworkopen.2019.17004.
  36. Abel MK, Kho KA, Walter A, et al. Measuring quality in minimally invasive gynecologic surgery: what, how, and why? J Minim Invasive Gynecol. 2019;26:321-326. doi: 10.1016/j.jmig.2018.11.013.
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2021 Update on abnormal uterine bleeding

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Tue, 07/13/2021 - 09:21

Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.1 They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.1 Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The new Cerene cryotherapy endometrial ablation method meets the FDA’s target for reduction of menstrual blood loss, but it has a slightly lower amenorrhea rate than other devices. Its most significant features are the potential for improved analgesia for in-office use and the possibility that there may be less scarring of the endometrial cavity for future assessment if needed.

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

 

 

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.2

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

The study by Go and colleagues highlights the significant psychosocial aspects of the heavy menstrual bleeding associated with fibroids, and the authors found that many women with fibroids score in the range of those with other significant diseases, such as breast cancer and diabetes.

We have noted the trend of including QoL in research, and Go and colleagues make an excellent and compelling argument for this trend using quantitative analysis. It is important to consider this not only in our design of future research but also, and perhaps more importantly, in our clinical care of women as we try to better understand what they are experiencing.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

 

 

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials3 and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)4 were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.5 These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.3 UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.3 Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”6 Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”6

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.5

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Elagolix plus hormonal add-back therapy provides several advantages to fibroid care, including a pill form that, as a gonadotropin-releasing hormone (GnRH) antagonist, provides much quicker action than GnRH agonists. The hormonal add-back feature seems to improve QoL measures and has a favorable reported bleeding reduction rate. It also appears to be reasonably safe. Although the studies reviewed here may have some weaknesses, it helps to have another therapy to offer to women who have blood loss associated with fibroids. Deciding on the drug’s optimal clinical use has not been fully explored, as it may be a short-term solution to a long-term problem and may not be ideal for all patients with fibroids. Elagolix and hormonal add-back therapy may be advantageous for patients who need to stop bleeding quickly and are trying to decide about their reproductive plans, for patients close to menopause who need a therapy to bridge this gap, and for patients trying to obtain relief between pregnancies.

 

References
  1. Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.
  2. Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674-708.e8.
  3. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
  4. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
  5. Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.
  6. Obstetrical & Gynecological Survey. 2020;75:545-547.
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Howard T. Sharp, MD

Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities and Quality, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.

Marisa R. Adelman, MD

Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.

Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.

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Howard T. Sharp, MD

Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities and Quality, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.

Marisa R. Adelman, MD

Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.

Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.

Author and Disclosure Information

Howard T. Sharp, MD

Dr. Sharp is Jon M. Huntsman Presidential Endowed Professor, Vice Chair for Clinical Activities and Quality, Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.

Marisa R. Adelman, MD

Dr. Adelman is Associate Professor, Department of Obstetrics and Gynecology, University of Utah Health.

Dr. Sharp reports being an author and editor and receiving royalties from UpToDate, Inc. Dr. Adelman reports no financial relationships relevant to this article.

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Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.1 They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.1 Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The new Cerene cryotherapy endometrial ablation method meets the FDA’s target for reduction of menstrual blood loss, but it has a slightly lower amenorrhea rate than other devices. Its most significant features are the potential for improved analgesia for in-office use and the possibility that there may be less scarring of the endometrial cavity for future assessment if needed.

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

 

 

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.2

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

The study by Go and colleagues highlights the significant psychosocial aspects of the heavy menstrual bleeding associated with fibroids, and the authors found that many women with fibroids score in the range of those with other significant diseases, such as breast cancer and diabetes.

We have noted the trend of including QoL in research, and Go and colleagues make an excellent and compelling argument for this trend using quantitative analysis. It is important to consider this not only in our design of future research but also, and perhaps more importantly, in our clinical care of women as we try to better understand what they are experiencing.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

 

 

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials3 and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)4 were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.5 These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.3 UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.3 Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”6 Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”6

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.5

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Elagolix plus hormonal add-back therapy provides several advantages to fibroid care, including a pill form that, as a gonadotropin-releasing hormone (GnRH) antagonist, provides much quicker action than GnRH agonists. The hormonal add-back feature seems to improve QoL measures and has a favorable reported bleeding reduction rate. It also appears to be reasonably safe. Although the studies reviewed here may have some weaknesses, it helps to have another therapy to offer to women who have blood loss associated with fibroids. Deciding on the drug’s optimal clinical use has not been fully explored, as it may be a short-term solution to a long-term problem and may not be ideal for all patients with fibroids. Elagolix and hormonal add-back therapy may be advantageous for patients who need to stop bleeding quickly and are trying to decide about their reproductive plans, for patients close to menopause who need a therapy to bridge this gap, and for patients trying to obtain relief between pregnancies.

 

Abnormal uterine bleeding (AUB) continues to be a top-10 reason why women present for gynecologic care, which makes keeping up with clinical therapies important. Over the past year, we have learned a tremendous amount about elagolix with hormonal add-back therapy for the treatment of bleeding associated with uterine fibroids. In this Update, we provide an overview from 3 randomized clinical trials on the recent US Food and Drug Administration (FDA)-approved drug, elagolix with hormonal add-back therapy (approved May 29, 2020). In addition, we review the data on the Cerene cryotherapy device (Channel Medsystems), as one might rightly ask, do we need another endometrial ablation device? We will address that question, as this device has some unique features that gynecologists should be aware of. Last, we review a study on the importance of considering quality of life in patients with uterine fibroids, which provides sobering information on the psychosocial aspects of uterine fibroids that all clinicians who care for such patients should be aware of.

Endometrial ablation with a new cryotherapy device: Is less more?

Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.

The phrase “less is more,” in the world of architecture and design, is often associated with Ludwig Mies van der Rohe (1886–1969). One could argue that this principle is one key advantage with the addition of yet another non-resectoscopic endometrial ablation device. The Cerene cryotherapy device, FDA approved in 2019, is presented as a simple, disposable device for in-office use that takes advantage of natural cryoanesthesia and results in less tissue destruction than many other ablation methods.

Device reduces bleeding and permits greater ability for future evaluation

Recently, Curlin and colleagues conducted a prospective, multicenter clinical trial to evaluate the safety and efficacy of the Cerene device in reducing menstrual blood loss.1 They followed 230 patients over 12 months and found that 81% (77% with intention-to-treat analysis) met the primary end point of a pictorial blood loss assessment chart (PBLAC) score of 75 or lower. Clinically, this translated to 44% of patients experiencing light bleeding; 27%, eumenorrhea; and 10%, amenorrhea. This is clearly “less” in terms of the rate of amenorrhea in most endometrial ablation studies. However, this also may translate into “more” ability to evaluate the endometrial cavity in the future, as 97% of the patients were able to undergo hysteroscopy at the 12-month mark and, of those, 93% were able to have the entire endometrial cavity assessed.

Further, of 97 patients who had a tubal sterilization, none had symptoms or evidence of postablation tubal sterilization syndrome. Three patients were unable to undergo hysteroscopy due to pain intolerance (2) or cervical stenosis (1). This is important because some gynecologists have expressed concern over intrauterine synechiae, which may result in scarring and associated future difficulty in assessing the endometrium for possible cancer.

Details about the device

The Cerene device is a single use, disposable device that uses cryothermal energy from nitrous oxide that results in a liquid-to-gas phase change within a polyurethane balloon (resulting in a temperature of -86°C) and delivered through a 6-mm sheath. It may be used in uterine cavities that measure between 2.5 and 6.5 cm in length, corresponding to approximately 10 cm in a uterine sound measurement. Treatment time is 2.5 minutes of nitrous oxide flow.

As mentioned, another benefit claimed is that the Cerene device’s cryoanalgesia properties enable the procedure to be more tolerated in the office setting. Of the 230 patients studied in the Curlin trial, no procedures were performed under general anesthesia.1 Medications used included paracervical block (PCB) only (8%), PCB plus nonsteroidal anti-inflammatory drugs (19.8%), PCB plus oral narcotics/anxiolytics (69%), and PCB plus intravenous sedation (2.9%), showing that this device is ideally suited for in-office use.

The rate of serious adverse events was 2.5% (7 total events in 6 patients within 12 months). All serious adverse events were reviewed by a Clinical Events Committee and none were deemed to be device-related events.

Long-term outcomes remain to be seen

For physicians and patients who worry about the ability to access the endometrial cavity in the future, less may be more. It will be interesting to see what the long-term outcomes show with use of the Cerene cryotherapy device, and whether a lower amenorrhea rate will translate into a higher repeat intervention rate or not. Of course, not all are minimalists. As the architect Robert Venturi (1925–2018) was quoted as saying, “Less is a bore.”

WHAT THIS EVIDENCE MEANS FOR PRACTICE
The new Cerene cryotherapy endometrial ablation method meets the FDA’s target for reduction of menstrual blood loss, but it has a slightly lower amenorrhea rate than other devices. Its most significant features are the potential for improved analgesia for in-office use and the possibility that there may be less scarring of the endometrial cavity for future assessment if needed.

Continue to: QoL assessment in women with fibroids is useful in evaluating treatment success...

 

 

QoL assessment in women with fibroids is useful in evaluating treatment success

Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674- 708.e8.

In many studies that assess AUB, the primary emphasis generally is placed on quantitation of menstrual bleeding by using PBLAC and alkaline hematin scores. In a systematic review, Go and colleagues argue the case for the importance of measuring the psychosocial impact of abnormal bleeding, emphasizing the concerning finding that many women with fibroids report lower vitality and lower social function scores than women with breast cancer.2

Fibroids associated with inconvenience—and anxiety

The authors analyzed and reviewed 18 randomized trials and 39 observational studies after screening 3,625 records from electronic database searches, with the goal to include only studies with validated quality of life (QoL) questionnaires that were administered both before and after treatment. A highlighted aspect of the reviewed studies was that “control” and “concern” subscales were most affected by fibroids, noting the inconvenience and anxiety that are related to the unpredictable onset and intensity of menses and the feeling of loss of control over one’s health and future.

This systematic review is important because although previous research has shown that fibroids significantly affect QoL, the psychosocial burden of fibroid symptoms had not been compared across different QoL instruments for both disease-specific and general validated health subscales.

Disability levels with fibroids are similar to those with other chronic diseases

Go and colleagues further reported that uterine fibroids have considerable psychosocial impact and lead to poor overall QoL physically and emotionally, with diminished sexual function and increased urinary or defecatory issues. Women with fibroids experienced a level of disability that was similar to that seen in other chronic diseases, and their vitality scores were lower than those associated with heart disease, diabetes, and as mentioned, breast cancer.

The authors concluded that “although objective clinical measures are important to establish a comprehensive understanding of health status, patient reported QoL outcomes play a critical role in evaluating success of a therapy.” They suggested that a larger emphasis on patient-centered care may help to mitigate the psychosocial effects of fibroids.

WHAT THIS EVIDENCE MEANS FOR PRACTICE

The study by Go and colleagues highlights the significant psychosocial aspects of the heavy menstrual bleeding associated with fibroids, and the authors found that many women with fibroids score in the range of those with other significant diseases, such as breast cancer and diabetes.

We have noted the trend of including QoL in research, and Go and colleagues make an excellent and compelling argument for this trend using quantitative analysis. It is important to consider this not only in our design of future research but also, and perhaps more importantly, in our clinical care of women as we try to better understand what they are experiencing.

Continue to: What have we learned over the past year about elagolix for uterine fibroids?...

 

 

What have we learned over the past year about elagolix for uterine fibroids?

Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.

Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.

Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.

Data from the Elaris UF-1 and UF-2 6-month, phase 3 trials3 and the results of the Elaris UF-EXTEND trial with a 6-month extension (totaling 12 months of use)4 were published in 2020, and the 12-month results were discussed in OBG Management (2020;32[7]:35, 39-40). An additional data analysis from the same researchers assessed the effect of elagolix with hormonal add-back therapy in a number of patient subgroups.5 These 3 publications have added to our knowledge of this therapy, and it is worth reviewing them in this context

Design of the elagolix plus hormonal add-back therapy trials

The initial UF-1 and UF-2 trials were 2 identical, double-blind, randomized, placebo-controlled, 6-month, phase 3 trials designed to evaluate the safety and efficacy of elagolix and hormonal add-back therapy.3 UF-1 was conducted at 76 sites in the United States from December 2015 through December 2018, whereas UF-2 was conducted at 77 sites in the United States and Canada from February 2016 through January 2019; the trials were registered separately. Both trials had a 2:1:1 randomization of elagolix (300 mg twice daily) with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg daily), elagolix alone (300 mg twice daily), or placebo.

In the 6-month studies, the primary end point was both menstrual blood loss of less than 80 mL and at least a 50% reduction of menstrual blood loss as measured by the alkaline hematin method.3 Among several secondary end points was the assessment of QoL using the Uterine Fibroid Symptom QoL questionnaire (UFS-QoL).

Trial results. In UF-1, 68.5% of 206 women, and in UF-2, 76.5% of 189 women, respectively, taking elagolix with add-back therapy met the primary objective. Among women taking elagolix alone, in UF-1, 84.1% of 104 women, and in UF-2, 77% of 95 women, respectively, met criteria. There was improvement in UFS-QoL scores in women receiving elagolix plus add-back therapy with a reduction of symptom severity of -33.2 in UF-1 and -41.4 in UF-2, as compared with the placebo-treated groups (-10.3 and -7.7, respectively).

Adverse effects. Elagolix was associated with a low incidence of serious adverse effects, and the addition of hormonal add-back therapy attenuated the decreases in bone mineral density observed with elagolix alone. In both UF-1 and UF-2 trials, bone mineral density did not differ significantly in the groups of women who received elagolix with hormonal addback therapy versus placebo.

The extension trial results

Of note, in the 12-month study (6-month extension), the authors reported that 87.9% of the women taking elagolix with hormonal add-back therapy met the primary objective.4 Among the women taking elagolix alone, 89.4% met the primary objective.

In a review of the AbbVie-funded extension study, the editorial comments in the Obstetrical and Gynecological Survey expressed concern over the high proportion of data loss, comparing the number of patients joining the extended trial, patients who completed an additional 6 months of treatment, and patients who completed the posttreatment follow-up period of “up to 12 months.”6 Approximately one-third of patients were lost between initial enrollment to the subset who completed follow-up. There was concern that “losses of that magnitude pose a serious threat to validity.”6

Effectiveness in subgroups

Al-Hendy and colleagues analyzed data from the Elaris UF-1 and UF-2 trials to see if the outcomes for elagolix with hormonal addback therapy demonstrated safety and efficacy in subgroups of patients of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume.5

Results. In all subgroups, they found a statistically significant reduction in blood loss in mean menstrual blood loss volume for those treated with elagolix plus hormonal addback therapy compared with those treated with placebo. As well, in terms of QoL, among all subgroups, the mean change in symptom severity score as well as health-related QoL total score from baseline to month 6 was statistically significantly greater than the mean change in the placebo group.

The bottom line

Elagolix with hormonal add-back therapy appears to be a safe and effective method to reduce menstrual blood loss associated with uterine fibroids. It also has a favorable effect on QoL and appears to have benefits in subgroups of women of varying ages, races and ethnicities, baseline menstrual blood loss, body mass indices, fibroid location, and uterine and fibroid volume. ●

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Elagolix plus hormonal add-back therapy provides several advantages to fibroid care, including a pill form that, as a gonadotropin-releasing hormone (GnRH) antagonist, provides much quicker action than GnRH agonists. The hormonal add-back feature seems to improve QoL measures and has a favorable reported bleeding reduction rate. It also appears to be reasonably safe. Although the studies reviewed here may have some weaknesses, it helps to have another therapy to offer to women who have blood loss associated with fibroids. Deciding on the drug’s optimal clinical use has not been fully explored, as it may be a short-term solution to a long-term problem and may not be ideal for all patients with fibroids. Elagolix and hormonal add-back therapy may be advantageous for patients who need to stop bleeding quickly and are trying to decide about their reproductive plans, for patients close to menopause who need a therapy to bridge this gap, and for patients trying to obtain relief between pregnancies.

 

References
  1. Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.
  2. Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674-708.e8.
  3. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
  4. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
  5. Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.
  6. Obstetrical & Gynecological Survey. 2020;75:545-547.
References
  1. Curlin HL, Cintron LC, Anderson TL. A prospective, multicenter, clinical trial evaluating the safety and effectiveness of the Cerene device to treat heavy menstrual bleeding. J Minim Invasive Gynecol. 2021;28:899-908.
  2. Go VAA, Thomas MC, Singh B, et al. A systematic review of the psychosocial impact of fibroids before and after treatment. Am J Obstet Gynecol. 2020;223:674-708.e8.
  3. Schlaff WD, Ackerman RT, Al-Hendy A, et al. Elagolix for heavy menstrual bleeding in women with uterine fibroids. N Engl J Med. 2020;382:328-340.
  4. Simon JA, Al-Hendy A, Archer DF, et al. Elagolix treatment for up to 12 months in women with heavy menstrual bleeding and uterine leiomyomas. Obstet Gynecol. 2020;135:1313-1326.
  5. Al-Hendy A, Bradley L, Owens CD, et al. Predictors of response for elagolix with add-back therapy in women with heavy menstrual bleeding associated with uterine fibroids. Am J Obstet Gynecol. 2021:224-72.e1-72.e50.
  6. Obstetrical & Gynecological Survey. 2020;75:545-547.
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Placental allograft, cytology processor, cell-free RNA testing, and male infertility

Article Type
Changed
Wed, 07/14/2021 - 14:08

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

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Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

 

Human placental allograft

Revita, an allograft composed of human placental membrane, developed by Stimlabs, is available to ObGyns and other health care professionals for many uses including surgery and wound care. The human placental membrane is composed of 3 layers, with single- and dual-layer placental allografts available since the 1990s, notes Stimlabs. Revita reserves all 3 layers, however, to include the intermediate layer, which contains hyaluronic acid and additional proteins. By including this jelly-like layer, the natural components of the native placental tissue are maximized, says Stimlabs, offering 6.55 times more growth factors and 4.3 times more protein content, and an overall thicker allograft, than competing products. The advantage is that many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues are retained.

For case reports involving Revita and for more information, visit https://www.stimlabs.com/revita.

FDA approval for cytology processor

Hologic announces US Food and Drug Administration approval for its ThinPrep® Genesis™ processor for cytology processing and specimen transfer. The Genesis is part of the company’s ThinPrep product line, which is focused on cervical cancer screening and was launched in 1996. This latest processor is designed to streamline downstream workflows with advanced automation capabilities that combine cytology processing with sample aliquoting, which helps to prevent misidentification of samples and allows for more confidence in results, says Hologic. In addition they say that features such as automated uncapping/capping and optional tube and slide printers automate labeling to reduce hands-on time by lab operators, improving ergonomics and streamlining performance for laboratories of any size.

For more information, visit: https://www.hologic.com/.

Cell-free RNA testing for pregnancy complications

Noninvasive prenatal testing (NIPT), which uses a blood test to identify maternal and fetal cell-free DNA, is a relatively new technology that can identify fetal genetic abnormalities such as chromosomal disorders. But what about identifying the risk of potential complications that can occur during pregnancy that can adversely affect the baby as well as the mother—conditions like preterm birth, preeclampsia, and gestational diabetes (GD)? These complications affect an estimated 45 million women globally each year. Mirvie is a company focused on using cell-free RNA testing of a single blood sample from the mother to assess the mother’s risk of developing pregnancy complications (including preterm birth, preeclampsia, and GD). The RNA testing reflects the state of the mother, baby, and the placenta. Mirvie is founded by the inventor of NIPT, and the company says they are making rapid progress toward their RNA-testing goal.


Currently, Mirvie is recruiting for their Miracle of Life study, which requests that single gestation pregnant mothers who are not scheduled for cesarean delivery provide a blood sample during their second trimester. Women can see if they are eligible for study participation by visiting https://www.curebase.com/study/miracle/home.

For more information, visit: https://mirvie.com/.

Male fertility platform

Newly launched Posterity Health is a Male Factor Management PlatformTM designed to help men optimize their fertility. From lifestyle and behavioral changes to increase the chances of conception to at-home semen analysis and a comprehensive, personalized treatment plan, Posterity Health has the fertility support built in. The platform also provides for virtual second opinions and consultations for vasectomy reversal and sperm cryopreservation. Posterity Health partners with fertility centers and ObGyns and currently can serve patients living in California, Colorado, and New York, with plans to expand services to other states.

For more information, visit: https://posterityhealth.com/.

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