Pelvic Floor Dysfunction

Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.

Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.

Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.

“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”

“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.

The commentary was published online in the Canadian Medical Association Journal.
 

Transparency needed

The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.

Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.

The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”

Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.

Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.

“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”

In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”

Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
 

Medicine before marketing

“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.” 

Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.

“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.” 

Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.  

“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”  

Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.” 

Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.

A version of this article first appeared on Medscape.com.

Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.

Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.

Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.

“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”

“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.

The commentary was published online in the Canadian Medical Association Journal.
 

Transparency needed

The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.

Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.

The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”

Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.

Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.

“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”

In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”

Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
 

Medicine before marketing

“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.” 

Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.

“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.” 

Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.  

“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”  

Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.” 

Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.

A version of this article first appeared on Medscape.com.

Laser devices licensed in Canada to treat genitourinary syndrome of menopause (GSM) are often marketed for vaginal rejuvenation with claims that they will tighten the vagina and improve sexual function, despite lack of evidence, a new commentary reveals.

Vaginal lasers heat the vaginal epithelium and cause thermal necrosis. This intervention induces collagen remodeling and synthesis, neovascularization, and elastin formation and may result in improved vaginal elasticity and restoration of premenopausal epithelial function, according to coauthors Blayne Welk, MD, MSc, an associate professor of urologic surgery at Western University, London, Ont., and Erin Kelly, MD, a lecturer in obstetrics and gynecology at the University of Alberta, Edmonton.

Their patients’ questions and experiences with the laser devices prompted the commentary, they told this news organization.

“A large part of my practice involves addressing GSM and urinary incontinence,” said Dr. Kelly. “Many women present to the clinic having heard of vaginal laser procedures, having had vaginal laser procedures, or having been told they need vaginal laser procedures. My impression has been that these procedures are being marketed to women … without rigorous study.”

“Many women are reluctant to have mesh slings for stress incontinence due to some of the potential risks,” and they are looking for less invasive options, said Dr. Welk. Over the past few years, he has had increasing questions from patients about the use of lasers to improve this condition.

The commentary was published online in the Canadian Medical Association Journal.
 

Transparency needed

The first vaginal energy device was licensed by Health Canada in 2015 to treat GSM. That meant the device was deemed to have met basic safety, effectiveness, and quality criteria. But no controlled studies are required for regulatory approval of such devices, and after licensing, some providers rebranded the device indication from GSM to vaginal rejuvenation, said Dr. Kelly and Dr. Welk.

Vaginal laser therapies are offered throughout Canada, with at least one provider of vaginal rejuvenation procedures in the 10 most populous cities. Under the current system, the number of patients who pay for these procedures and the amount that they pay cannot be tracked. Nor can the number of vaginal laser systems active in Canada be tracked. Patients can refer themselves for the service, and providers’ publicly quoted costs (on websites, for example) are thousands of dollars for treatment.

The rebranding for vaginal rejuvenation “represents a difference between the licensing of a medical device by Health Canada and the way that these devices are used and marketed,” according to the commentary. “A procedure with limited high-quality evidence supporting its efficacy and a potential financial conflict of interest for providers may not be serving the best interests of people in Canada, even if the risk of adverse events is low.”

Updates to Canada’s medical devices action plan, including mandatory reporting of serious incidents and the ability to compel manufacturers to provide information on safety and effectiveness, “represent important progress,” according to Dr. Kelly and Dr. Welk. However, problems persist, including lack of a requirement for peer-reviewed, controlled studies.

Furthermore, women who undergo laser treatment for GSM, urinary incontinence, or vaginal rejuvenation may not receive a proper medical evaluation and standard treatments, the authors noted.

“I would like to see more transparency and public-facing information available on approved medical devices,” said Dr. Welk. “Health Canada has an online database of approved devices, but no information around the evidence submitted during the approval process is available, nor are the indications for the various devices.”

In addition, he said, many devices in the registry are listed by a serial number rather than the name that would be familiar to the public, “making it hard to match up information.”

Dr. Kelly added the “encouraging” news that the Canadian Society for Pelvic Medicine is working with Health Canada to “improve knowledge translation when it comes to transparency regarding medical devices.”
 

Medicine before marketing

“The commentary provides an accurate and evidence-based assessment of the use of vaginal laser treatments,” Jason Abbott, B Med (Hons), PhD, professor of gynecology at the University of New South Wales, Sydney, told this news organization. “The marketing of this device is a case of putting the cart before the horse. It is essential that strong, scientific, and reproducible studies be available on efficacy and safety before there is a direct-to-consumer marketing approach.” 

Clinicians should advise patients when the treatment effect is likely to be minimal or risky, especially when there is a financial incentive to the clinician, he said. “Governments, regulators, and medical societies have a duty of care to the public to make sure that the medicine comes before the marketing. Otherwise, we are no better than snake oil sellers.

“Given the size of studies to date, the improvement in symptoms following treatment may be less than a few percent,” he noted. “That may be acceptable to some women. We don’t know.” 

Dr. Abbott’s team is conducting research to define what women would want as a minimal level of improvement, the maximum cost, and the maximum risk from the laser procedure.  

“In cancer … the benefit of a new treatment may only be a few percent for survival,” he said. “That may be completely acceptable for some or even many patients. What we cannot do, however, is extrapolate those same expectations to a treatment for a benign condition where quality of life is compromised.”  

Echoing Dr. Kelly and Dr. Welk, Dr. Abbott said, “It is important that there be transparency in the clinical communication. Patients should be told that the best scientific studies that are judged based on their quality show there is no benefit to laser treatment for GSM or urinary incontinence.” 

Although the medical risks may be low, he added, “financial risk also needs to be discussed. Patients should be encouraged to participate in clinical trials where there is no cost to them to gain the information first, before wholesale uptake of the treatment. … Should patients still wish to undergo the procedure once the risks and an honest account of the evidence is given to them, that of course is their choice.” Dr. Kelly, Dr. Welk, and Dr. Abbott had no commercial funding or relevant financial relationships to report.

A version of this article first appeared on Medscape.com.

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

A version of this article first appeared on Medscape.com.

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

A version of this article first appeared on Medscape.com.

The standard nonsurgical treatment for pelvic organ prolapse does not appear to work as well as surgery to correct the problem, Dutch researchers have found. 

Pelvic organ prolapse is an uncomfortable condition, causing a troublesome vaginal bulge, often accompanied by urinary, bowel, or sexual dysfunction. Between 3% and 6% of women develop symptomatic prolapse, with the highest incidence in women aged 60-69 years – a fast-growing demographic.

Although many women choose surgical treatment, the American College of Obstetricians and Gynecologists recommends that women be offered a vaginal pessary as a noninvasive alternative, despite inconsistent data from observational studies on their effectiveness.

Lisa van der Vaart, MD, a doctoral student in ob.gyn. at the University of Amsterdam and the lead author of the new study, published in JAMA, said that differences in outcome measures, small sample size, and lack of long-term follow-up have bedeviled previous comparisons of the two techniques.

“We thought it was very important to perform a randomized control trial on this subject to improve counseling to women who suffer from symptomatic pelvic organ prolapse,” Dr. van der Vaart said.

She and her colleagues conducted a noninferiority randomized clinical trial that recruited 1,605 women with stage II or higher prolapse who were referred to specialty care at 21 hospitals in the Netherlands between 2015 and 2019. Of the 440 women who agreed to participate in the trial, 218 received a pessary, a device inserted into the vagina that provides support to tissues displaced by prolapse, and 222 underwent surgery.

The primary outcome was subjective improvement using a standardized questionnaire at 24 months; women were asked to rank their symptoms on a seven-point scale, and subjective improvement was defined as a response of much better or very much better.

“We saw a substantial amount of improvement in both groups,” Dr. van der Vaart said in an interview.

After 24 months of follow-up, outcome data were available for 173 women in the pessary group and 162 in the surgery group. For this intention-to treat population, 76.3% in the pessary group and 81.5% in the surgery group reported improvement.

Results were similar for the smaller group of participants who completed the study per protocol, without crossing over to a treatment to which they had not been allocated.

However, neither the intention-to-treat nor per-protocol analysis met the prespecified criteria for noninferiority, suggesting that use of a vaginal pessary is not equivalent to surgery.

The study also found differences in adverse events. Among women randomly assigned to surgery, 9% suffered a postoperative urinary tract infection, and 5.4% underwent additional therapy, such as pessary or repeat operation.

But use of a pessary also had downsides. The most common adverse event was discomfort (42.7%), and by 24 months, 60% of the participants in the pessary group had discontinued use.

Dr. van der Vaart said that she was surprised by the high number of women assigned to the pessary group who later elected to undergo surgery. “Women should be told that their chance of crossing over to a surgical intervention is quite high – more than 50% do eventually end up having surgery.”

Cheryl Iglesia, MD, director of the National Center for Advanced Pelvic Surgery at MedStar Health and professor of obstetrics and gynecology and urology at Georgetown University, both in Washington, was also struck by the high crossover rate. “We’ve had the same pessaries probably for the last 100 years,” she said. “We need to get better.”

Dr. Iglesia welcomed new approaches to making vaginal pessaries that are custom designed for each woman’s unique anatomy using 3D printing and pointed to promising initial clinical trials of disposable pessaries. With the aging of the population and demand for treatment of prolapse increasing, she cited a need for better nonsurgical alternatives: “We have a work-force issue and may not have enough adequately trained urogynecologists to meet the demand for prolapse repairs as our population ages.”

The study was funded by a grant from ZonMW, a Dutch governmental health care organization. Dr. van der Vaart reported grants from ZonMW during the conduct of the study.

A version of this article first appeared on Medscape.com.

Knowledge of the latest evidence on the management of pelvic floor disorders is essential for all practicing ObGyns. In this Update, we review long-term outcomes for a polyacrylamide hydrogel urethral bulking agent for the treatment of stress urinary incontinence (SUI) that presents a viable alternative to the gold standard, midurethral sling. We review the new recommendations from the American Urogynecologic Society (AUGS) regarding the administration of anticholinergics, highlighting a paradigm shift in the management of overactive bladder (OAB). In addition, we present data on a proposed threshold glycosylated hemoglobin A_1c (HbA_1c) level for patients undergoing pelvic organ prolapse (POP) surgery that may help reduce the risk of perioperative complications. Finally, we consider new evidence on the long-term efficacy and safety of transvaginal mesh for repair of POP.

Periurethral injection with  polyacrylamide hydrogel is a  long-term durable and safe  option for women with SUI

Brosche T, Kuhn A, Lobodasch K, et al. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502-508. doi:10.1002/nau.24589.

Urethral bulking agents are a less invasive management option for women with SUI compared with the gold standard, midurethral sling. Treatment with a polyacrylamide hydrogel (PAHG; Bulkamid)—a nonparticulate hydrogel bulking agent—showed long-term efficacy and a favorable safety profile at 7 years’ follow-up.

Study details

Brosche and colleagues conducted a retrospective cohort study that included women with SUI or stress-predominant mixed urinary incontinence (MUI) who underwent transurethral PAHG injections for primary treatment of their incontinence symptoms. The study objective was to evaluate the long-term efficacy of PAHG based on patient satisfaction. Treatment safety was a secondary outcome.

Pad counts and validated questionnaires were used to determine treatment effectiveness. Additional data on reinjection rates, perioperative complications, and postoperative complications also were collected.

Long-term outcomes favorable

During the study time period, 1,200 patients were treated with PAHG, and 7-year data were available for 553 women. Of the 553 patients, 67% reported improvement or cure of their SUI symptoms when PAHG was performed as a primary procedure, consistent with previously published 12-month data. There were no perioperative complications. Postoperative complications were transient. Short-term subjective prolonged bladder emptying was the most common complication and occurred in 15% of patients.

Continue to: New society guidance...

New society guidance on the use  of anticholinergic medications  for the treatment of OAB

AUGS Clinical Consensus Statement: Association of anticholinergic medication use and cognition in women with overactive bladder. Female Pelvic Med Reconstr Surg. 2021;27:69-71. doi:10.1097/ SPV.0000000000001008.

In 2021, AUGS updated its consensus statement on the use of anticholinergic medications for the treatment of OAB. This action was in response to growing evidence that supports the association of anticholinergic medications with long-term cognitive adverse effects, including cognitive impairment, dementia, and Alzheimer disease.

Here, we summarize the most recent modifications, which differentiate the updated statement from the preceding consensus document published in 2017.

Updated AUGS recommendations

• If considering anticholinergic medications, counsel patients about the risk of cognitive adverse effects and weigh these risks against the potential benefits to their quality of life and overall health.
• Use the lowest possible dose when prescribing anticholinergics and consider alternatives such as β3 agonists (for example, mirabegron or vibegron).
• Avoid using anticholinergic medications in women older than age 70. However, if an anticholinergic must be used, consider a medication that has low potential to cross the blood-brain barrier (for example, trospium).

 HbA_1c levels > 8% may increase complications risk in urogyn surgery

Ringel NE, de Winter KL, Siddique M, et al. Surgical outcomes in urogynecology—assessment of perioperative and postoperative complications relative to preoperative hemoglobin A1c—a Fellows Pelvic Research Network study. Female Pelvic Med Reconstr Surg. 2022;28:7-13. doi:10.1097/ SPV.0000000000001057.

Diabetes mellitus is a known risk factor for complications following surgery. Adoption of an HbA_1c level threshold for risk stratification before urogynecologic surgery may help improve patient outcomes.

Study details

Ringel and colleagues conducted a multicenter retrospective cohort study that included women with diabetes mellitus who underwent prolapse and/or SUI surgery between 2013 and 2018. The aim of the study was to identify a hemoglobin A_1C threshold that would help predict increased risk for perioperative complications in women undergoing pelvic reconstructive surgery. Demographics, preoperative HbA_1c levels, and surgical data were collected.

Complication risks correlated with higher HbA_1c threshold

The study included 807 women with HbA_1c values that ranged from 5% to 12%. The overall complication rate was 44%. Sensitivity analysis was performed to compare complication rates between patients with varying HbA_1c levels and determine a threshold HbA_1c value with the greatest difference in complication rates.

The authors concluded that women with an HbA_1c level ≥ 8% showed the greatest increase of perioperative complications. Patients with an HbA_1c ≥ 8%, compared with those who had an HbA_1c < 8%, had a statistically significantly increased rate of overall (58% vs 42%, P = .002) and severe (27% vs 13%, P< .001) perioperative complications.

After multivariate logistic regression, the risk of overall complications remained elevated, with a 1.9-times higher risk of perioperative complications for women with an HbA_1c ≥ 8%.

Continue to:  Success is similar for TV mesh  and native tissue repair...

Success is similar for TV mesh  and native tissue repair

Kahn B, Varner RE, Murphy M, et al. Transvaginal mesh compared with native tissue repair for pelvic organ prolapse. Obstet Gynecol. 2022;139:975-985. doi:10.1097/AOG.0000000000004794.

The distribution of vaginal mesh kits for the repair of POP was halted by the US Food and Drug Administration (FDA) in 2019. However, concerns have been raised about the measures used by the FDA to justify pulling these devices from the market. A cohort study compared 36-month outcomes between women who underwent prolapse repair with newer generation transvaginal mesh versus native tissue repair.

Study details

In a nonrandomized prospective multicenter cohort study, Kahn and colleagues compared outcomes in women with POP who underwent native tissue repair or transvaginal mesh repair with the Uphold LITE vaginal support system. The study’s objective was to compare the safety and efficacy of native tissue and transvaginal mesh prolapse repairs at 36 months postoperatively.

Treatment success was measured based on composite and individual measures of anatomic and subjective success, need for retreatment, and the occurrence of adverse events. Quality of life (QoL) measures also were obtained using validated questionnaires. Intention-to-treat and per-protocol analyses were performed.

Composite success rate was higher for mesh repair

A total of 710 patients were screened for eligibility (225 received transvaginal mesh and 485 received native tissue repair). Transvaginal mesh placement was found to be significantly superior to native tissue repair for composite success (84% vs 73%, P = .009) when prolapse within the hymen (that is, Ba and/or C < 0 on the Pelvic Organ Prolapse Quantification System) was used to define anatomic success.

Adverse events were similar between transvaginal mesh and native tissue repair groups, with most adverse events occurring within the first 6 months. The mesh exposure rate was 4.9%. Of the 13 incidents of mesh exposure, 4 patients required surgical intervention and 1 incident was considered a serious adverse event. QoL measures demonstrated improvement without any statistically significant differences between the treatment cohorts. ●

Knowledge of the latest evidence on the management of pelvic floor disorders is essential for all practicing ObGyns. In this Update, we review long-term outcomes for a polyacrylamide hydrogel urethral bulking agent for the treatment of stress urinary incontinence (SUI) that presents a viable alternative to the gold standard, midurethral sling. We review the new recommendations from the American Urogynecologic Society (AUGS) regarding the administration of anticholinergics, highlighting a paradigm shift in the management of overactive bladder (OAB). In addition, we present data on a proposed threshold glycosylated hemoglobin A_1c (HbA_1c) level for patients undergoing pelvic organ prolapse (POP) surgery that may help reduce the risk of perioperative complications. Finally, we consider new evidence on the long-term efficacy and safety of transvaginal mesh for repair of POP.

Periurethral injection with  polyacrylamide hydrogel is a  long-term durable and safe  option for women with SUI

Brosche T, Kuhn A, Lobodasch K, et al. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502-508. doi:10.1002/nau.24589.

Urethral bulking agents are a less invasive management option for women with SUI compared with the gold standard, midurethral sling. Treatment with a polyacrylamide hydrogel (PAHG; Bulkamid)—a nonparticulate hydrogel bulking agent—showed long-term efficacy and a favorable safety profile at 7 years’ follow-up.

Study details

Brosche and colleagues conducted a retrospective cohort study that included women with SUI or stress-predominant mixed urinary incontinence (MUI) who underwent transurethral PAHG injections for primary treatment of their incontinence symptoms. The study objective was to evaluate the long-term efficacy of PAHG based on patient satisfaction. Treatment safety was a secondary outcome.

Pad counts and validated questionnaires were used to determine treatment effectiveness. Additional data on reinjection rates, perioperative complications, and postoperative complications also were collected.

Long-term outcomes favorable

During the study time period, 1,200 patients were treated with PAHG, and 7-year data were available for 553 women. Of the 553 patients, 67% reported improvement or cure of their SUI symptoms when PAHG was performed as a primary procedure, consistent with previously published 12-month data. There were no perioperative complications. Postoperative complications were transient. Short-term subjective prolonged bladder emptying was the most common complication and occurred in 15% of patients.

Continue to: New society guidance...

New society guidance on the use  of anticholinergic medications  for the treatment of OAB

AUGS Clinical Consensus Statement: Association of anticholinergic medication use and cognition in women with overactive bladder. Female Pelvic Med Reconstr Surg. 2021;27:69-71. doi:10.1097/ SPV.0000000000001008.

In 2021, AUGS updated its consensus statement on the use of anticholinergic medications for the treatment of OAB. This action was in response to growing evidence that supports the association of anticholinergic medications with long-term cognitive adverse effects, including cognitive impairment, dementia, and Alzheimer disease.

Here, we summarize the most recent modifications, which differentiate the updated statement from the preceding consensus document published in 2017.

Updated AUGS recommendations

• If considering anticholinergic medications, counsel patients about the risk of cognitive adverse effects and weigh these risks against the potential benefits to their quality of life and overall health.
• Use the lowest possible dose when prescribing anticholinergics and consider alternatives such as β3 agonists (for example, mirabegron or vibegron).
• Avoid using anticholinergic medications in women older than age 70. However, if an anticholinergic must be used, consider a medication that has low potential to cross the blood-brain barrier (for example, trospium).

 HbA_1c levels > 8% may increase complications risk in urogyn surgery

Ringel NE, de Winter KL, Siddique M, et al. Surgical outcomes in urogynecology—assessment of perioperative and postoperative complications relative to preoperative hemoglobin A1c—a Fellows Pelvic Research Network study. Female Pelvic Med Reconstr Surg. 2022;28:7-13. doi:10.1097/ SPV.0000000000001057.

Diabetes mellitus is a known risk factor for complications following surgery. Adoption of an HbA_1c level threshold for risk stratification before urogynecologic surgery may help improve patient outcomes.

Study details

Ringel and colleagues conducted a multicenter retrospective cohort study that included women with diabetes mellitus who underwent prolapse and/or SUI surgery between 2013 and 2018. The aim of the study was to identify a hemoglobin A_1C threshold that would help predict increased risk for perioperative complications in women undergoing pelvic reconstructive surgery. Demographics, preoperative HbA_1c levels, and surgical data were collected.

Complication risks correlated with higher HbA_1c threshold

The study included 807 women with HbA_1c values that ranged from 5% to 12%. The overall complication rate was 44%. Sensitivity analysis was performed to compare complication rates between patients with varying HbA_1c levels and determine a threshold HbA_1c value with the greatest difference in complication rates.

The authors concluded that women with an HbA_1c level ≥ 8% showed the greatest increase of perioperative complications. Patients with an HbA_1c ≥ 8%, compared with those who had an HbA_1c < 8%, had a statistically significantly increased rate of overall (58% vs 42%, P = .002) and severe (27% vs 13%, P< .001) perioperative complications.

After multivariate logistic regression, the risk of overall complications remained elevated, with a 1.9-times higher risk of perioperative complications for women with an HbA_1c ≥ 8%.

Continue to:  Success is similar for TV mesh  and native tissue repair...

Success is similar for TV mesh  and native tissue repair

Kahn B, Varner RE, Murphy M, et al. Transvaginal mesh compared with native tissue repair for pelvic organ prolapse. Obstet Gynecol. 2022;139:975-985. doi:10.1097/AOG.0000000000004794.

The distribution of vaginal mesh kits for the repair of POP was halted by the US Food and Drug Administration (FDA) in 2019. However, concerns have been raised about the measures used by the FDA to justify pulling these devices from the market. A cohort study compared 36-month outcomes between women who underwent prolapse repair with newer generation transvaginal mesh versus native tissue repair.

Study details

In a nonrandomized prospective multicenter cohort study, Kahn and colleagues compared outcomes in women with POP who underwent native tissue repair or transvaginal mesh repair with the Uphold LITE vaginal support system. The study’s objective was to compare the safety and efficacy of native tissue and transvaginal mesh prolapse repairs at 36 months postoperatively.

Treatment success was measured based on composite and individual measures of anatomic and subjective success, need for retreatment, and the occurrence of adverse events. Quality of life (QoL) measures also were obtained using validated questionnaires. Intention-to-treat and per-protocol analyses were performed.

Composite success rate was higher for mesh repair

A total of 710 patients were screened for eligibility (225 received transvaginal mesh and 485 received native tissue repair). Transvaginal mesh placement was found to be significantly superior to native tissue repair for composite success (84% vs 73%, P = .009) when prolapse within the hymen (that is, Ba and/or C < 0 on the Pelvic Organ Prolapse Quantification System) was used to define anatomic success.

Adverse events were similar between transvaginal mesh and native tissue repair groups, with most adverse events occurring within the first 6 months. The mesh exposure rate was 4.9%. Of the 13 incidents of mesh exposure, 4 patients required surgical intervention and 1 incident was considered a serious adverse event. QoL measures demonstrated improvement without any statistically significant differences between the treatment cohorts. ●

Knowledge of the latest evidence on the management of pelvic floor disorders is essential for all practicing ObGyns. In this Update, we review long-term outcomes for a polyacrylamide hydrogel urethral bulking agent for the treatment of stress urinary incontinence (SUI) that presents a viable alternative to the gold standard, midurethral sling. We review the new recommendations from the American Urogynecologic Society (AUGS) regarding the administration of anticholinergics, highlighting a paradigm shift in the management of overactive bladder (OAB). In addition, we present data on a proposed threshold glycosylated hemoglobin A_1c (HbA_1c) level for patients undergoing pelvic organ prolapse (POP) surgery that may help reduce the risk of perioperative complications. Finally, we consider new evidence on the long-term efficacy and safety of transvaginal mesh for repair of POP.

Periurethral injection with  polyacrylamide hydrogel is a  long-term durable and safe  option for women with SUI

Brosche T, Kuhn A, Lobodasch K, et al. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021;40:502-508. doi:10.1002/nau.24589.

Urethral bulking agents are a less invasive management option for women with SUI compared with the gold standard, midurethral sling. Treatment with a polyacrylamide hydrogel (PAHG; Bulkamid)—a nonparticulate hydrogel bulking agent—showed long-term efficacy and a favorable safety profile at 7 years’ follow-up.

Study details

Brosche and colleagues conducted a retrospective cohort study that included women with SUI or stress-predominant mixed urinary incontinence (MUI) who underwent transurethral PAHG injections for primary treatment of their incontinence symptoms. The study objective was to evaluate the long-term efficacy of PAHG based on patient satisfaction. Treatment safety was a secondary outcome.

Pad counts and validated questionnaires were used to determine treatment effectiveness. Additional data on reinjection rates, perioperative complications, and postoperative complications also were collected.

Long-term outcomes favorable

During the study time period, 1,200 patients were treated with PAHG, and 7-year data were available for 553 women. Of the 553 patients, 67% reported improvement or cure of their SUI symptoms when PAHG was performed as a primary procedure, consistent with previously published 12-month data. There were no perioperative complications. Postoperative complications were transient. Short-term subjective prolonged bladder emptying was the most common complication and occurred in 15% of patients.

Continue to: New society guidance...

New society guidance on the use  of anticholinergic medications  for the treatment of OAB

AUGS Clinical Consensus Statement: Association of anticholinergic medication use and cognition in women with overactive bladder. Female Pelvic Med Reconstr Surg. 2021;27:69-71. doi:10.1097/ SPV.0000000000001008.

In 2021, AUGS updated its consensus statement on the use of anticholinergic medications for the treatment of OAB. This action was in response to growing evidence that supports the association of anticholinergic medications with long-term cognitive adverse effects, including cognitive impairment, dementia, and Alzheimer disease.

Here, we summarize the most recent modifications, which differentiate the updated statement from the preceding consensus document published in 2017.

Updated AUGS recommendations

• If considering anticholinergic medications, counsel patients about the risk of cognitive adverse effects and weigh these risks against the potential benefits to their quality of life and overall health.
• Use the lowest possible dose when prescribing anticholinergics and consider alternatives such as β3 agonists (for example, mirabegron or vibegron).
• Avoid using anticholinergic medications in women older than age 70. However, if an anticholinergic must be used, consider a medication that has low potential to cross the blood-brain barrier (for example, trospium).

 HbA_1c levels > 8% may increase complications risk in urogyn surgery

Ringel NE, de Winter KL, Siddique M, et al. Surgical outcomes in urogynecology—assessment of perioperative and postoperative complications relative to preoperative hemoglobin A1c—a Fellows Pelvic Research Network study. Female Pelvic Med Reconstr Surg. 2022;28:7-13. doi:10.1097/ SPV.0000000000001057.

Diabetes mellitus is a known risk factor for complications following surgery. Adoption of an HbA_1c level threshold for risk stratification before urogynecologic surgery may help improve patient outcomes.

Study details

Ringel and colleagues conducted a multicenter retrospective cohort study that included women with diabetes mellitus who underwent prolapse and/or SUI surgery between 2013 and 2018. The aim of the study was to identify a hemoglobin A_1C threshold that would help predict increased risk for perioperative complications in women undergoing pelvic reconstructive surgery. Demographics, preoperative HbA_1c levels, and surgical data were collected.

Complication risks correlated with higher HbA_1c threshold

The study included 807 women with HbA_1c values that ranged from 5% to 12%. The overall complication rate was 44%. Sensitivity analysis was performed to compare complication rates between patients with varying HbA_1c levels and determine a threshold HbA_1c value with the greatest difference in complication rates.

The authors concluded that women with an HbA_1c level ≥ 8% showed the greatest increase of perioperative complications. Patients with an HbA_1c ≥ 8%, compared with those who had an HbA_1c < 8%, had a statistically significantly increased rate of overall (58% vs 42%, P = .002) and severe (27% vs 13%, P< .001) perioperative complications.

After multivariate logistic regression, the risk of overall complications remained elevated, with a 1.9-times higher risk of perioperative complications for women with an HbA_1c ≥ 8%.

Continue to:  Success is similar for TV mesh  and native tissue repair...

Success is similar for TV mesh  and native tissue repair

Kahn B, Varner RE, Murphy M, et al. Transvaginal mesh compared with native tissue repair for pelvic organ prolapse. Obstet Gynecol. 2022;139:975-985. doi:10.1097/AOG.0000000000004794.

The distribution of vaginal mesh kits for the repair of POP was halted by the US Food and Drug Administration (FDA) in 2019. However, concerns have been raised about the measures used by the FDA to justify pulling these devices from the market. A cohort study compared 36-month outcomes between women who underwent prolapse repair with newer generation transvaginal mesh versus native tissue repair.

Study details

In a nonrandomized prospective multicenter cohort study, Kahn and colleagues compared outcomes in women with POP who underwent native tissue repair or transvaginal mesh repair with the Uphold LITE vaginal support system. The study’s objective was to compare the safety and efficacy of native tissue and transvaginal mesh prolapse repairs at 36 months postoperatively.

Treatment success was measured based on composite and individual measures of anatomic and subjective success, need for retreatment, and the occurrence of adverse events. Quality of life (QoL) measures also were obtained using validated questionnaires. Intention-to-treat and per-protocol analyses were performed.

Composite success rate was higher for mesh repair

A total of 710 patients were screened for eligibility (225 received transvaginal mesh and 485 received native tissue repair). Transvaginal mesh placement was found to be significantly superior to native tissue repair for composite success (84% vs 73%, P = .009) when prolapse within the hymen (that is, Ba and/or C < 0 on the Pelvic Organ Prolapse Quantification System) was used to define anatomic success.

Adverse events were similar between transvaginal mesh and native tissue repair groups, with most adverse events occurring within the first 6 months. The mesh exposure rate was 4.9%. Of the 13 incidents of mesh exposure, 4 patients required surgical intervention and 1 incident was considered a serious adverse event. QoL measures demonstrated improvement without any statistically significant differences between the treatment cohorts. ●

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

obgm0340936_zycynski_t1.jpg

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

obgm0340936_zycynski_f1.jpg

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

obgm0340936_zycynski_f2.jpg

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

obgm0340936_zycynski_f3.jpg

obgm0340936_zycynski_f4.jpg

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

obgm0340936_zycynski_t2.jpg

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

obgm0340936_zycynski_t1.jpg

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

obgm0340936_zycynski_f1.jpg

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

obgm0340936_zycynski_f2.jpg

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

obgm0340936_zycynski_f3.jpg

obgm0340936_zycynski_f4.jpg

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

obgm0340936_zycynski_t2.jpg

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

CASE Patient has urine leakage that worsens with exercise

At her annual preventative health visit, a 39-year-old woman reports that she has leakage of urine. She states that she drinks “a gallon of water daily” to help her lose the 20 lb she gained during the COVID-19 pandemic. She wants to resume Zumba fitness classes, but exercise makes her urine leakage worse. She started wearing protective pads because she finds herself often leaking urine on the way to the bathroom.

What nonsurgical treatment options are available for this patient?

Nearly half of all women experience urinary incontinence (UI), the involuntary loss of urine, and the condition increases with age.¹ This common condition negatively impacts physical and psychological health and has been associated with social isolation, sexual dysfunction, and reduced independence^.2,3 Symptoms of UI are underreported, and therefore universal screening is recommended for women of all ages.⁴ The diversity of available treatments (TABLE 1) provides patients and clinicians an opportunity to develop a plan that aligns with their symptom severity, goals, preferences, and resources.

obgm0340936_zycynski_t1.jpg

Types of UI

The most common types of UI are stress urinary incontinence (SUI) and urgency urinary incontinence (UUI). Mixed urinary incontinence (MUI) occurs when symptoms of both SUI and UUI are present. Although the mechanisms that lead to urine leakage vary by the type of incontinence, many primary interventions improve both types of leakage, so a clinical diagnosis is sufficient to initiate treatment.

Stress urinary incontinence results from an impaired or weakened sphincter, which leads to involuntary, yet predictable, urine loss during increased abdominal pressure, such as coughing, laughing, sneezing, lifting, or physical activity.⁵ In UUI, involuntary loss of urine often accompanies the sudden urge to void. UUI is associated with overactive bladder (OAB), defined as urinary urgency, with or without urinary incontinence, usually accompanied by urinary frequency and/or nocturia (urination that interrupts sleep).⁶

In OAB, the detrusor muscle contracts randomly, leading to a sudden urge to void. When bladder pressure exceeds urethral sphincter closure pressure, urine leakage occurs. Women describe the urgency episodes as unpredictable, the urine leakage as prolonged with large volumes, and often occurring as they seek the toilet. Risk factors include age, obesity, parity, history of vaginal delivery, family history, ethnicity/race, medical comorbidities, menopausal status, and tobacco use.⁵

Making a diagnosis

A basic office evaluation is the most key step for diagnostic accuracy that leads to treatment success. This includes a detailed history, assessment of symptom severity, physical exam, pelvic exam, urinalysis, postvoid residual (to rule out urinary retention), and a cough stress test (to demonstrate SUI). The goal is to assess symptom severity, determine the type of UI, and identify contributing and potentially reversible factors, such as a urinary tract infection, medications, pelvic organ prolapse, incomplete bladder emptying, or impaired neurologic status. In the absence of the latter, advanced diagnostic tests, such as urodynamics, contribute little toward discerning the type of incontinence or changing first-line treatment plans.⁷

During the COVID-19 pandemic, abbreviated, virtual assessments for urinary symptoms were associated with high degrees of satisfaction (91% for fulfillment of personal needs, 94% overall satisfaction).⁸ This highlights the value of validated symptom questionnaires that help establish a working diagnosis and treatment plan in the absence of a physical exam. Questionnaire-based diagnoses have acceptable accuracy for classifying UUI and SUI among women with uncomplicated medical and surgical histories and for initiating low-risk therapies for defined intervals.

The 3 incontinence questions (3IQ) screen is an example of a useful, quick diagnostic tool designed for the primary care setting (FIGURE 1).⁹ It has been used in pharmaceutical treatment trials for UUI, with low frequency of misdiagnosis (1%–4%), resulting in no harm by the drug treatment prescribed or by the delay in appropriate care.¹⁰ Due to the limitations of an abbreviated remote evaluation, however, clinicians should assess patient response to primary interventions in a timely window. Patients who fail to experience satisfactory symptom reduction within 6 to 12 weeks should complete their evaluation in person or through a referral to a urogynecology program.

obgm0340936_zycynski_f1.jpg

Continue to: Primary therapies for UI...

Primary therapies for UUI and SUI target strength training of the pelvic floor muscles, moderation of fluid intake, and adjustment in voiding behaviors and medications. Any functional barriers to continence also should be identified and addressed. Simple interventions, including a daily bowel regimen to address constipation, a bedside commode, and scheduled voiding, may reduce incontinence episodes without incurring significant cost or risk. For women suspected of having MUI, the treatment plan should prioritize their most bothersome symptoms.

Lifestyle and behavioral modifications

Everyday habits, medical comorbidities, and medications may exacerbate the severity of both SUI and UUI. Behavioral therapy alone or in combination with other interventions effectively reduces both SUI and UUI symptoms and has been shown to improve the efficacy of continence surgery.¹¹ Information gained from a 3-day bladder diary (FIGURE 2)¹² can guide clinicians on personalized patient recommendations, such as reducing excessive consumption of fluids and bladder irritants, limiting late evening drinking in the setting of bothersome nocturia, and scheduling voids (every 2–3 hours) to preempt incontinence episodes.

obgm0340936_zycynski_f2.jpg

Weight loss

Obesity is a strong, independent, modifiable risk factor for both SUI and UUI. Each 5 kg/m² increase in body mass index (BMI) has been associated with a 20% to 70% increased risk of UI, while weight loss of 5% or greater in overweight or obese women can lead to at least a 50% decrease in UI frequency.¹³

Reducing fluid intake and bladder irritants

Overactive bladder symptoms often respond to moderation of excessive fluid intake and reduction of bladder irritants (caffeine, carbonated beverages, diet beverages, and alcohol). While there is no established definition of excess caffeine intake, one study categorized high caffeine intake as greater than 400 mg/day (approximately four 8-oz cups of coffee).¹⁴

Information provided in a bladder diary can guide individualized recommendations for reducing fluid intake, particularly when 24-hour urine production exceeds the normative range (> 50–60 oz or 1.5-1.8 L/day).¹⁵ Hydration needs vary by activity, environment, and food; some general guidelines suggest 48 to 64 oz/day.^5,16

Continue to: Pelvic floor muscle training...

Pelvic floor muscle training

An effective treatment for both UUI and SUI symptoms, pelvic floor muscle training (PFMT) leads to high degrees of patient satisfaction and improvement in quality of life.¹⁷ The presumed mechanisms of action of PFMT include improved urethral closure pressure and inhibition of detrusor muscle contractions.

Common exercise protocols recommend 3 sets of 10 contractions, held for 6 to 10 seconds per day, in varying positions of sitting, standing, and lying. While many women may be familiar with Kegel exercises, poor technique with straining and recruitment of gluteal and abdominal muscles can undermine the effect of PFMT. Clinicians can confirm successful pelvic muscle contractions by placing a finger in the vagina to appreciate contraction around and elevation of the finger toward the pubic symphysis in the absence of pushing.

Referral to supervised physical therapy and use of such teaching aid tools as booklets, mobile applications, and biofeedback can improve exercise adherence and outcomes.^18,19 Systematic reviews report initial cure or improvement of incontinence symptoms as high as 74%, although little information is available about the long-term duration of effect.¹⁷

Vaginal pessaries

Vaginal continence support pessaries and devices work by stabilizing urethral mobility and compression of the bladder neck. Continence devices are particularly effective for situational SUI (such as during exercise).

The reusable medical grade silicone pessaries are available in numerous shapes and sizes and are fitted by a health care clinician (FIGURE 3). Uresta is a self-fitted intravaginal device that women can purchase online with a prescription. The Poise Impressa bladder support is a disposable intravaginal device marketed for incontinence and available over-the-counter, without a prescription (FIGURE 4). Anecdotally, many women find that menstrual tampons provide a similar effect, but outcome data are lacking.

obgm0340936_zycynski_f3.jpg

obgm0340936_zycynski_f4.jpg

UUI-specific nonsurgical treatments

Drug therapy

All medications approved by the US Food and Drug Administration (FDA) for UI are for the indications of OAB or UUI. These second-line treatments are most effective as adjuncts to behavioral modifications and PFMT.

A multicenter randomized trial that evaluated the efficacy of drug therapy alone compared with drug therapy in combination with behavioral modification, PFMT, urge suppression strategies, timed voiding, and fluid management for UUI found that combined therapy was more successful in achieving greater than 70% reduction in incontinence episodes (58% for drug therapy vs 69% for combined therapy).²¹

Of the 8 medications currently marketed in the United States for OAB or UUI, 6 are anticholinergic agents that block muscarinic receptors in the smooth muscle of the bladder, leading to inhibition of detrusor contractions, and 2 are β-adrenergic receptor agonists that promote bladder storage capacity by relaxing the detrusor muscle (TABLE 2). Similar efficacies lead most clinicians to initiate drug therapy based on formulary coverage and tolerance for adverse effects. Patients can expect a 53% to 80% reduction in UUI episodes and a 12% to 32% reduction in urinary frequency.²²

obgm0340936_zycynski_t2.jpg

Continue to: UUI office-based procedure treatments...

UUI office-based procedure treatments

If behavioral therapies and medications are ineffective, contraindicated, or not the patient’s preference, additional FDA-approved therapies for UUI are available, typically through referral to a urogynecologist, urologist, or continence center.

Posterior tibial nerve stimulation (PTNS) is a nondrug treatment that delivers electrical stimulation using an acupuncture needle for 12 weekly 30-minute sessions followed by monthly maintenance for responders. The time commitment for this treatment plan can be a barrier for some patients. However, patients who adhere to the recommended protocol can expect a 60% improvement in symptoms, with minimal adverse events. Treatment efficacy is comparable to that of anticholinergic medication.²⁴

OnabotulinumtoxinA injections into the bladder muscle are performed cystoscopically under local anesthetic. The toxin blocks the presynaptic release of acetylcholine at the neuromuscular junction, resulting in temporary muscle paralysis. This treatment is associated with high satisfaction. Efficacy varies by study population and outcome measure.

In one US comparative effectiveness trial, 67% of study participants with UUI symptoms refractory to oral medication reported a greater than 50% reduction in OAB symptoms at 6 months, 20% reported complete resolution of UUI, and 72% requested a second injection within 24 months.²⁵ The interval between the first and second injection was nearly 1 year (350 days).Risks include urinary tract infection (12% within 1 month of the procedure and 35% through 6 months); urinary retention requiring catheterization has decreased to 6% with recognition that most moderate retention is tolerated by patients.

Some insurers limit onabotulinumtoxinA treatment coverage to patients who have failed to achieve symptom control with first- and second-line treatments.

SUI-specific nonsurgical treatments

Cystoscopic injection of urethral bulking agents into the urethral submucosa is designed to improve urethral coaptation. It is a minor procedure that can be performed in an ambulatory setting under local anesthetic with or without sedation.

Various bulking agents have been approved for use in the United States, some of which have been withdrawn due to complications of migration, erosion, and pseudoabscess formation. Cure or improvement after bulking agent injection was found to be superior to a home pelvic floor exercise program but inferior to a midurethral sling procedure for cure (9% vs 89%).²⁶

The durability of currently available urethral bulking agents beyond 1 year is unknown. Complications are typically minor and transient and include pain at the injection site, urinary retention, de novo urgency, and implant leakage. The advantages include no postprocedure activity restrictions.

CASE Symptom presentation guides treatment plan

Our patient described symptoms of stress-predominant MUI. She was counseled to moderate her fluid intake to 2 L per day and to strategically time voids (before exercise, and at least every 4 hours). The patient was fitted with an incontinence pessary, and she elected to pursue a course of supervised physical therapy for pelvic floor muscle strengthening. Her follow-up visit is scheduled in 3 months to determine if other interventions are warranted. ●

After New York–based yoga instructor Erin Conley’s two sisters gave birth, Ms. Conley suggested a few advanced poses to help strengthen their pelvic floor.

“With one of my sisters, she said, ‘Honestly right now, I just can’t even stand up,’ ” she recalled.

Ms. Conley’s other sister could do slightly more advanced poses – leading Ms. Conley to recognize that after delivery, women’s ability to practice yoga varied widely.

“Post-birth is certainly a progression for each woman,” she said. “You can’t just go into these advance postures.”

Ms. Conley tailored a slow sequence of 30-second poses that each sister could start with, and they eventually reported an improvement of pelvic floor issues. Ms. Conley’s suggestions to her sisters are backed by a small but growing body of research. One study published in August in the journal Urology suggests that yoga may be a way to help treat multiple types of pelvic floor disorders.

More than 1 in 4 women in the United States experience pelvic floor disorders such as bowel or urinary incontinence or pelvic organ prolapse, many as a result of giving birth. But less than 15% of these women seek medical treatment for their symptoms, according to Hari Tunuguntla, MD, associate professor of urologic surgery at Rutgers University’s Robert Wood Johnson Medical School, New Brunswick.

For those who do seek medical help, many patients have trouble complying with initial lifestyle-based recommendations, such as refraining from drinking caffeinated and carbonated beverages, Dr. Tunuguntla said.

“It requires a lot of persistence and knowledge and compliance,” he said.

Medication and physical therapy are routes doctors can order before considering surgery, but some patients find clinical-based interventions to be costly. The cost of the interventions can add up depending on what a person’s insurance policy covers, Dr. Tunuguntla said.

With those struggles in mind, he and his colleagues set out to study the efficacy of the mobile app Yoga of Immortals, which offers a holistic form of yoga that includes postures, breathing exercises, sound therapy, and meditation.

“It includes sound therapy, summative breathing exercise,” Dr. Tunuguntla said. “These are useful not just for the condition but for general well-being.”

For the study, Dr. Tunuguntla and his colleagues emailed surveys to 420 people between ages 18 and 74 years in 23 countries who reported having any type of urinary incontinence, regardless of severity. The participants, most of whom were women, used the yoga app for 30 minutes a day for 8 weeks.

More than three-quarters of participants reported that the frequency and severity of their incontinence improved after 8 weeks of practice, compared with when they started, without having to visit their health care provider. Most participants also said that they felt “very much better” after 8 weeks, compared with when they began the yoga regimen, the researchers found.

The study did not compare the effectiveness of the approach with other standard treatments for incontinence, like physical therapy, medication, or surgery.

Ms. Conley, an instructor since 2010, said that one of the benefits of yoga is building strength and flexibility slowly and simultaneously. She uses yoga poses that focus less on movement and more on holding positions for longer periods of time.

“I’ll do sequences of a mountain pose with a block to activate the core in the most basic ways and really focus on the breathing,” she said.

Another benefit of slower forms of yoga is that they can help participants become more aware of the structures of their pelvic floor, according to Alison Huang, MD, professor of medicine, urology and epidemiology, and biostatistics at University of California, San Francisco.

“In some ways we can think of it as a complementary substitute for rehabilitation therapy,” Dr. Huang said.

Dr. Huang and her colleagues published a short report recently in The Journal of Integrative and Complementary Medicine, showing that even telehealth-based yoga programs for older women with urinary incontinence can offer an accessible way for women of any background to take advantage of yoga’s benefits.

An estimated 93% of 66 participants who practiced yoga through planned telehealth appointments reported feeling “very or moderately satisfied” with their practice. Dr. Huang said that the study is not yet complete but offers a glimpse into some of the advantages of yoga for women with urinary incontinence.

“Any kind of treatment that relies on intensive one-on-one visits with specialists is going to be harder to access for some women,” Dr. Huang told this news organization. “Yoga is typically practiced in a community setting, outside of traditional health care settings.”

The accessibility of yoga and its community-based practice may help eliminate any obstacles to care and compliance that clinicians like she and Dr. Tunuguntla at times experience. Mounting studies have also indicated that yoga may help improve overall wellness, manage stress, promote healthier eating, and benefit a person’s mental and emotional health.

Despite emerging research on the link between yoga and pelvic floor disorders, Dr. Huang said that it’s still early for clinicians to recommend the exercise form for every patient.

“We just don’t have the [solid] evidence to show your pelvic floor will improve,” she said.

“For any woman who is starting out more sedentary, I think there are benefits to practic[ing] yoga for overall health,” Dr. Huang said. “Most clinicians would say there are opportunities to practice yoga regularly in a way that is safe, with a knowledgeable instructor.”

According to Ms. Conley, yoga is only as beneficial as a person’s level of consistency in the practice.

“The dedication to yoga is your willingness to showing up,” she said. “I think depending on your commitment to the practice, if you’re really committed to the practice – just like you show up to physical therapy every day – you will improve,” said Ms. Conley.

“Being gentle and patient with the process is important too,” she said.

Dr. Tunuguntla and coauthors report no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

After New York–based yoga instructor Erin Conley’s two sisters gave birth, Ms. Conley suggested a few advanced poses to help strengthen their pelvic floor.

“With one of my sisters, she said, ‘Honestly right now, I just can’t even stand up,’ ” she recalled.

Ms. Conley’s other sister could do slightly more advanced poses – leading Ms. Conley to recognize that after delivery, women’s ability to practice yoga varied widely.

“Post-birth is certainly a progression for each woman,” she said. “You can’t just go into these advance postures.”

Ms. Conley tailored a slow sequence of 30-second poses that each sister could start with, and they eventually reported an improvement of pelvic floor issues. Ms. Conley’s suggestions to her sisters are backed by a small but growing body of research. One study published in August in the journal Urology suggests that yoga may be a way to help treat multiple types of pelvic floor disorders.

More than 1 in 4 women in the United States experience pelvic floor disorders such as bowel or urinary incontinence or pelvic organ prolapse, many as a result of giving birth. But less than 15% of these women seek medical treatment for their symptoms, according to Hari Tunuguntla, MD, associate professor of urologic surgery at Rutgers University’s Robert Wood Johnson Medical School, New Brunswick.

For those who do seek medical help, many patients have trouble complying with initial lifestyle-based recommendations, such as refraining from drinking caffeinated and carbonated beverages, Dr. Tunuguntla said.

“It requires a lot of persistence and knowledge and compliance,” he said.

Medication and physical therapy are routes doctors can order before considering surgery, but some patients find clinical-based interventions to be costly. The cost of the interventions can add up depending on what a person’s insurance policy covers, Dr. Tunuguntla said.

With those struggles in mind, he and his colleagues set out to study the efficacy of the mobile app Yoga of Immortals, which offers a holistic form of yoga that includes postures, breathing exercises, sound therapy, and meditation.

“It includes sound therapy, summative breathing exercise,” Dr. Tunuguntla said. “These are useful not just for the condition but for general well-being.”

For the study, Dr. Tunuguntla and his colleagues emailed surveys to 420 people between ages 18 and 74 years in 23 countries who reported having any type of urinary incontinence, regardless of severity. The participants, most of whom were women, used the yoga app for 30 minutes a day for 8 weeks.

More than three-quarters of participants reported that the frequency and severity of their incontinence improved after 8 weeks of practice, compared with when they started, without having to visit their health care provider. Most participants also said that they felt “very much better” after 8 weeks, compared with when they began the yoga regimen, the researchers found.

The study did not compare the effectiveness of the approach with other standard treatments for incontinence, like physical therapy, medication, or surgery.

Ms. Conley, an instructor since 2010, said that one of the benefits of yoga is building strength and flexibility slowly and simultaneously. She uses yoga poses that focus less on movement and more on holding positions for longer periods of time.

“I’ll do sequences of a mountain pose with a block to activate the core in the most basic ways and really focus on the breathing,” she said.

Another benefit of slower forms of yoga is that they can help participants become more aware of the structures of their pelvic floor, according to Alison Huang, MD, professor of medicine, urology and epidemiology, and biostatistics at University of California, San Francisco.

“In some ways we can think of it as a complementary substitute for rehabilitation therapy,” Dr. Huang said.

Dr. Huang and her colleagues published a short report recently in The Journal of Integrative and Complementary Medicine, showing that even telehealth-based yoga programs for older women with urinary incontinence can offer an accessible way for women of any background to take advantage of yoga’s benefits.

An estimated 93% of 66 participants who practiced yoga through planned telehealth appointments reported feeling “very or moderately satisfied” with their practice. Dr. Huang said that the study is not yet complete but offers a glimpse into some of the advantages of yoga for women with urinary incontinence.

“Any kind of treatment that relies on intensive one-on-one visits with specialists is going to be harder to access for some women,” Dr. Huang told this news organization. “Yoga is typically practiced in a community setting, outside of traditional health care settings.”

The accessibility of yoga and its community-based practice may help eliminate any obstacles to care and compliance that clinicians like she and Dr. Tunuguntla at times experience. Mounting studies have also indicated that yoga may help improve overall wellness, manage stress, promote healthier eating, and benefit a person’s mental and emotional health.

Despite emerging research on the link between yoga and pelvic floor disorders, Dr. Huang said that it’s still early for clinicians to recommend the exercise form for every patient.

“We just don’t have the [solid] evidence to show your pelvic floor will improve,” she said.

“For any woman who is starting out more sedentary, I think there are benefits to practic[ing] yoga for overall health,” Dr. Huang said. “Most clinicians would say there are opportunities to practice yoga regularly in a way that is safe, with a knowledgeable instructor.”

According to Ms. Conley, yoga is only as beneficial as a person’s level of consistency in the practice.

“The dedication to yoga is your willingness to showing up,” she said. “I think depending on your commitment to the practice, if you’re really committed to the practice – just like you show up to physical therapy every day – you will improve,” said Ms. Conley.

“Being gentle and patient with the process is important too,” she said.

Dr. Tunuguntla and coauthors report no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

After New York–based yoga instructor Erin Conley’s two sisters gave birth, Ms. Conley suggested a few advanced poses to help strengthen their pelvic floor.

“With one of my sisters, she said, ‘Honestly right now, I just can’t even stand up,’ ” she recalled.

Ms. Conley’s other sister could do slightly more advanced poses – leading Ms. Conley to recognize that after delivery, women’s ability to practice yoga varied widely.

“Post-birth is certainly a progression for each woman,” she said. “You can’t just go into these advance postures.”

Ms. Conley tailored a slow sequence of 30-second poses that each sister could start with, and they eventually reported an improvement of pelvic floor issues. Ms. Conley’s suggestions to her sisters are backed by a small but growing body of research. One study published in August in the journal Urology suggests that yoga may be a way to help treat multiple types of pelvic floor disorders.

More than 1 in 4 women in the United States experience pelvic floor disorders such as bowel or urinary incontinence or pelvic organ prolapse, many as a result of giving birth. But less than 15% of these women seek medical treatment for their symptoms, according to Hari Tunuguntla, MD, associate professor of urologic surgery at Rutgers University’s Robert Wood Johnson Medical School, New Brunswick.

For those who do seek medical help, many patients have trouble complying with initial lifestyle-based recommendations, such as refraining from drinking caffeinated and carbonated beverages, Dr. Tunuguntla said.

“It requires a lot of persistence and knowledge and compliance,” he said.

Medication and physical therapy are routes doctors can order before considering surgery, but some patients find clinical-based interventions to be costly. The cost of the interventions can add up depending on what a person’s insurance policy covers, Dr. Tunuguntla said.

With those struggles in mind, he and his colleagues set out to study the efficacy of the mobile app Yoga of Immortals, which offers a holistic form of yoga that includes postures, breathing exercises, sound therapy, and meditation.

“It includes sound therapy, summative breathing exercise,” Dr. Tunuguntla said. “These are useful not just for the condition but for general well-being.”

For the study, Dr. Tunuguntla and his colleagues emailed surveys to 420 people between ages 18 and 74 years in 23 countries who reported having any type of urinary incontinence, regardless of severity. The participants, most of whom were women, used the yoga app for 30 minutes a day for 8 weeks.

More than three-quarters of participants reported that the frequency and severity of their incontinence improved after 8 weeks of practice, compared with when they started, without having to visit their health care provider. Most participants also said that they felt “very much better” after 8 weeks, compared with when they began the yoga regimen, the researchers found.

The study did not compare the effectiveness of the approach with other standard treatments for incontinence, like physical therapy, medication, or surgery.

Ms. Conley, an instructor since 2010, said that one of the benefits of yoga is building strength and flexibility slowly and simultaneously. She uses yoga poses that focus less on movement and more on holding positions for longer periods of time.

“I’ll do sequences of a mountain pose with a block to activate the core in the most basic ways and really focus on the breathing,” she said.

Another benefit of slower forms of yoga is that they can help participants become more aware of the structures of their pelvic floor, according to Alison Huang, MD, professor of medicine, urology and epidemiology, and biostatistics at University of California, San Francisco.

“In some ways we can think of it as a complementary substitute for rehabilitation therapy,” Dr. Huang said.

Dr. Huang and her colleagues published a short report recently in The Journal of Integrative and Complementary Medicine, showing that even telehealth-based yoga programs for older women with urinary incontinence can offer an accessible way for women of any background to take advantage of yoga’s benefits.

An estimated 93% of 66 participants who practiced yoga through planned telehealth appointments reported feeling “very or moderately satisfied” with their practice. Dr. Huang said that the study is not yet complete but offers a glimpse into some of the advantages of yoga for women with urinary incontinence.

“Any kind of treatment that relies on intensive one-on-one visits with specialists is going to be harder to access for some women,” Dr. Huang told this news organization. “Yoga is typically practiced in a community setting, outside of traditional health care settings.”

The accessibility of yoga and its community-based practice may help eliminate any obstacles to care and compliance that clinicians like she and Dr. Tunuguntla at times experience. Mounting studies have also indicated that yoga may help improve overall wellness, manage stress, promote healthier eating, and benefit a person’s mental and emotional health.

Despite emerging research on the link between yoga and pelvic floor disorders, Dr. Huang said that it’s still early for clinicians to recommend the exercise form for every patient.

“We just don’t have the [solid] evidence to show your pelvic floor will improve,” she said.

“For any woman who is starting out more sedentary, I think there are benefits to practic[ing] yoga for overall health,” Dr. Huang said. “Most clinicians would say there are opportunities to practice yoga regularly in a way that is safe, with a knowledgeable instructor.”

According to Ms. Conley, yoga is only as beneficial as a person’s level of consistency in the practice.

“The dedication to yoga is your willingness to showing up,” she said. “I think depending on your commitment to the practice, if you’re really committed to the practice – just like you show up to physical therapy every day – you will improve,” said Ms. Conley.

“Being gentle and patient with the process is important too,” she said.

Dr. Tunuguntla and coauthors report no relevant financial relationships. 

A version of this article first appeared on Medscape.com.

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Abdel-Fattah M, Cooper D, Davidson T, et al. Single-incision mini-slings for stress urinary incontinence in women. N Engl J Med. 2022;386:1230-1243.

EXPERT COMMENTARY

A joint society position statement by the American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction published in December 2021 declared synthetic midurethral slings, first cleared for use in the United States in the early 1990s, the most extensively studied anti-incontinence operation and the standard of care for the treatment of female stress urinary incontinence.¹ Full-length retropubic and transobturator (out-in and in-out) slings have been extensively evaluated for safety and efficacy in well-conducted randomized trials.² Single-incision mini-slings (SIMS) were first cleared for use in 2006, but they lack the long-term safety and comparative effectiveness data of full-length standard midurethral slings (SMUS).³ Furthermore, several iterations of the mini-slings have come to market but have been withdrawn or modified to allow for adjustability.

The SIMS trial by Abdel-Fattah and colleagues, published recently in the New England Journal of Medicine, is one of the few randomized trials with long-term (3 year) subjective and objective outcome data based on comparison of adjustable single-incision mini-slings versus standard full-length midurethral slings.

Details of the study

The SIMS trial is a noninferiority multicenter randomized controlled trial funded by the National Institute for Health Research at 21 hospitals in the United Kingdom that compared adjustable mini-sling procedures performed under local anesthesia with full-length retrotropubic and transobturator sling procedures performed under general anesthesia. Patients and surgeons were not masked to study group assignment because of the differences in anesthesia, and patients with greater than stage 2 prolapse were excluded from the trial.

The primary outcome was Patient Global Impression of Improvement (PGI-I) based on a 7-point Likert scale, with success defined as very much improved or much improved at 15 months and failure defined as all other responses (improved, same, worse, much worse, and very much worse). A noninferiority margin was set at 10 percentage points at 15 months.

Secondary outcomes and adverse events at 36 months included postoperative pain, return to normal activities, objective success based on a 24-hour pad test weight of less than 8 g, and tape exposure, organ injury, new or worsening urinary urgency, dyspareunia, and need for prolonged catheterization.

A total of 596 women were enrolled in the study, 298 in the mini-sling arm and 298 in the standard midurethral sling arm. Baseline characteristics were similar in both groups with most sling procedures being performed by general consultant gynecologists (>60%) versus subspecialist urogynecologists.

Results. Success at 15 months, based on the PGI-I responses of very much better or much better, was noted in 79.1% of patients in the mini-sling group (212/268) versus 75.6% in the full-length sling group (189/250). The authors deemed mini-slings noninferior to standard full-length slings (adjusted risk difference, 4.6 percentage points; 95% confidence interval [CI], -2.7 to 11.8; P<.001 for noninferiority). Success rates declined but remained similar in both groups at 36 months: 72% in the mini-sling group (177/246) and 66.8% (157/235) in the full-length sling group.

More than 70% of mini-incision slings were Altis (Coloplast) and 22% were Ajust (CR Bard; since withdrawn from the market). The majority of standard midurethral full-length slings were transobturator slings (52.9%) versus retropubic slings (35.6%).

While blood loss, organ injury, and 36-month objective 24-hour pad test did not differ between groups, there were significant differences in other secondary outcomes. Dyspareunia and coital incontinence were more common with mini-slings at 15 and 36 months, reported in 11.7% of the mini-sling group and 4.8% of the full-length group (P<.01). Groin or thigh pain did not differ significantly between groups at 36 months (14.1% in mini-sling and 14.9% in full-length sling group, P = .61). Mesh exposure was noted in 3.3% of those with mini-slings and 1.9% of those with standard midurethral slings. The need for surgical intervention to treat recurrent stress incontinence or mesh removal for voiding dysfunction, pain, or mesh exposure also did not differ between groups (8.7% of the mini-sling group and 4.6% of the midurethral sling group; P = .12).

Study strengths and limitations

The strengths of this pragmatic randomized trial are in the use of clinically important and validated patient-reported subjective and objective outcomes in an adequately powered multisite trial of long duration (36 months). This study is important in demonstrating noninferiority of the mini-sling procedure compared with full-length slings, especially given this trial’s timing when there was a pause or suspension of sling mesh use in the United Kingdom beginning in 2018.

Study limitations include the loss to follow-up with diminished response rate of 87.1% at 15 months and 81.4% at 36 months and the inability to adequately assess for the uncommon outcomes, such as mesh-related complications and groin pain.

Further analysis needed

The high rate of dyspareunia (11.7%) with mini-slings deserves further analysis and consideration of whether or not to implant them in patients who are sexually active. Groin or thigh pain did not differ at 36 months but reported pain coincided with the higher percentage of transobturator slings placed over retropubic slings. Prior randomized trials of transobturator versus retropubic midurethral slings have demonstrated this same phenomenon of increased groin pain with the transobturator approach.² Furthermore, this study by Abdel-Fattah and colleagues excluded patients with advanced anterior or apical prolapse, but one trial is currently underway in the United States.⁴

In conclusion, this trial suggests some advantages of single-incision mini-slings—ability to perform the procedure under local anesthesia, less synthetic mesh implantation with theoretically decreased risk of bladder perforation or bowel injury, and potential for easier removal compared with full-length slings. Disadvantages include dyspareunia and mesh exposure, which could be significant trade-offs for patients. ●

Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Surgeons may significantly underestimate how long it will take women to return to normal activities following sling surgery to correct stress urinary incontinence, a new study has found.

The researchers found that just over 40% of women reported returning to work and other normal activities within 2 weeks of having undergone midurethral sling procedures – a much less optimistic forecast than what surgeons typically provide in these cases.

“This is in contrast to a published survey of physicians that showed the majority of surgeons suggested patients return to work within 2 weeks,” Rui Wang, MD, a fellow in female pelvic medicine and reconstructive surgery at Hartford Hospital, Conn., said in an interview.

Dr. Wang referred to a published survey of 135 physicians that was conducted at a 2018 meeting of the Society of Gynecologic Surgeons. In that survey, 88% of respondents indicated that patients could return to sedentary work within 2 weeks after undergoing sling surgery. Most recommended longer waits before returning to manual labor.

The authors of the survey noted a lack of consensus guidelines and wide variations in recommendations for postoperative restrictions after minimally invasive gynecologic and pelvic reconstructive surgery, which the researchers called a “largely unstudied field.”

Dr. Wang said, “The majority of patients may need more than 2 weeks to return to work and normal activities even following minimally invasive outpatient surgeries such as midurethral sling.”

Dr. Wang is scheduled to present the findings June 18 at the annual meeting of the American Urogynecologic Society.

For the new study, Dr. Wang and a colleague examined how patients answered questions about their activity levels during recovery after sling procedures. The patients were enrolled in the Trial of Mid-Urethral Slings (TOMUS), a randomized controlled trial that compared two types of midurethral slings used for the treatment of stress urinary incontinence: the retropubic midurethral mesh sling and the transobturator midurethral sling. Results of the trial were published in 2010.

Of 597 women enrolled in TOMUS, 441 were included in the new analysis. Patients who underwent another surgery at the same time as their sling procedure were excluded from the analysis.

As part of the trial, patients were asked how many paid workdays they took off after surgery; whether they had returned to full normal activities of daily life, including work, if applicable; and how much time it took for them to fully return to normal activities of daily life, including work.

The researchers found that 183 (41.5%) returned to normal activities within 2 weeks of the procedure. Among those patients, the median recovery time was 6 days. Within 6 weeks of surgery, 308 (70%) had returned to normal activities, including work. After 6 months, 407 (98.3%) were back to their normal routines, the study showed.

Multivariate regression analysis yielded no factor that predicted the timing of returning to normal activity and work. Nor did the researchers observe any significant differences in failure rates and adverse outcomes between patients who returned within 2 weeks or after 2 weeks.
 

Essential information for patient planning

Dr. Wang said she expects that the findings will help physicians in counseling patients and setting postoperative recovery expectations. “For patients planning elective surgery, one of the most important quality-of-life issues is the time they will need to take off from work and recover,” she said.

Although most patients needed more than 2 weeks to recover, the median paid time off after surgery was 4 days. “Many patients would have taken unpaid days off or used vacation time for their postoperative recovery,” Dr. Wang said.

She added that more research is needed to explore whether that discrepancy disproportionately affects women in jobs with fewer employee benefits. “We did not find that age, race/ethnicity, marital status, occupation, symptom severity, and duration of surgery significantly predicted the timing of return to work or normal activities,” she said. “But are there other factors, such as geographic location, insurance status, [or] income, that may affect this timing?”

Sarah Boyd, MD, an assistant professor in the Division of Female Pelvic Medicine and Reconstructive Surgery at Penn State College of Medicine, Hershey, said the new findings add concrete information that can guide patients in planning their recovery.

“Previously, surgeons could only provide general estimates to these patients based on the experience of their patients,” Dr. Boyd, who was not involved in the study, told this news organization.

The analysis has not been published in a peer-reviewed journal, and Dr. Boyd said that the findings may not pertain to all individuals who undergo midurethral sling procedures, such as people who have had prior surgery for incontinence or those who undergo surgery for other pelvic floor disorders at the same time.

Dr. Wang and Dr. Boyd reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Transvaginal mesh was found to be safe and effective for patients with pelvic organ prolapse (POP) when compared with native tissue repair (NTR) in a 3-year trial.

Researchers, led by Bruce S. Kahn, MD, with the department of obstetrics & gynecology at Scripps Clinic in San Diego evaluated the two surgical treatment methods and published their findings in Obstetrics & Gynecology.

At completion of the 3-year follow-up in 2016, there were 401 participants in the transvaginal mesh group and 171 in the NTR group.

The prospective, nonrandomized, parallel-cohort, 27-site trial used a primary composite endpoint of anatomical success; subjective success (vaginal bulging); retreatment measures; and serious device-related or serious procedure-related adverse events.

The secondary endpoint was a composite outcome similar to the primary composite outcome but with anatomical success more stringently defined as POP quantification (POP-Q) point Ba < 0 and/or C < 0.

The secondary outcome was added to this trial because investigators had criticized the primary endpoint, set by the Food and Drug Administration, because it included anatomic outcome measures that were the same for inclusion criteria (POP-Q point Ba < 0 and/or C < 0.)

The secondary-outcome composite also included quality-of-life measures, mesh exposure, and mesh- and procedure-related complications.
 

Outcomes similar for both groups

The primary outcome demonstrated transvaginal mesh was not superior to native tissue repair (P =.056).

In the secondary outcome, superiority of transvaginal mesh over native tissue repair was shown (P =.009), with a propensity score–adjusted difference of 10.6% (90% confidence interval, 3.3%-17.9%) in favor of transvaginal mesh.

The authors noted that subjective success regarding vaginal bulging, which is important in patient satisfaction, was high and not statistically different between the two groups.

Additionally, transvaginal mesh repair was as safe as NTR regarding serious device-related and/or serious procedure-related side effects.

For the primary safety endpoint, 3.1% in the mesh group and 2.7% in the native tissue repair group experienced serious adverse events, demonstrating that mesh was noninferior to NTR.
 

Research results have been mixed

Unanswered questions surround surgical options for POP, which, the authors wrote, “affects 3%-6% of women based on symptoms and up to 50% of women based on vaginal examination.”

The FDA in 2011 issued 522 postmarket surveillance study orders for companies that market transvaginal mesh for POP.

Research results have varied and contentious debate has continued in the field. Some studies have shown that mesh has better subjective and objective outcomes than NTR in the anterior compartment. Others have found more complications with transvaginal mesh, such as mesh exposure and painful intercourse.

Complicating comparisons, early versions of the mesh used were larger and denser than today’s versions.

In this postmarket study, patients received either the Uphold LITE brand of transvaginal mesh or native tissue repair for surgical treatment of POP.
 

Expert: This study unlikely to change minds

In an accompanying editorial, John O.L. DeLancey, MD, professor of gynecology at the University of Michigan, Ann Arbor, pointed out that so far there’s been a lack of randomized trials that could answer whether mesh surgeries result in fewer symptoms or result in sufficient improvements in anatomy to justify their additional risk.

This study may not help with the decision. Dr. DeLancey wrote: “Will this study change the minds of either side of this debate? Probably not. The two sides are deeply entrenched in their positions.”

Two considerations are important in thinking about the issue, he said. Surgical outcomes for POP are “not as good as we would hope.” Also, many women have had serious complications with mesh operations.

He wrote: “Mesh litigation has resulted in more $8 billion in settlements, which is many times the $1 billion annual national cost of providing care for prolapse. Those of us who practice in referral centers have seen women with devastating problems, even though they probably represent a small fraction of cases.”

Dr. DeLancey highlighted some limitations of the study by Dr. Kahn and colleagues, especially regarding differences in the groups studied and the design of the study.

“For example,” he explained, “65% of individuals in the mesh-repair group had a prior hysterectomy as opposed to 30% in the native tissue repair group. In addition, some of the operations in the native tissue group are not typical choices; for example, hysteropexy was used for some patients and had a 47% failure rate.”

He said the all-or-nothing approach to surgical solutions may be clouding the debate – in other words mesh or no mesh for women as a group.

“Rather than asking whether mesh is better than no mesh, knowing which women (if any) stand to benefit from mesh is the critical question. We need to understand, for each woman, what structural failures exist so that we can target our interventions to correct them,” he wrote.

This study was sponsored by Boston Scientific. Dr. Kahn disclosed research support from Solaire, payments from AbbVie and Douchenay as a speaker, payments from Caldera and Cytuity (Boston Scientific) as a medical consultant, and payment from Johnson & Johnson as an expert witness. One coauthor disclosed that money was paid to her institution from Medtronic and Boston Scientific (both unrestricted educational grants for cadaveric lab). Another is chief medical officer at Axonics. One study coauthor receives research funding from Axonics and is a consultant for Group Dynamics, Medpace, and FirstThought. One coauthor received research support, is a consultant for Boston Scientific, and is an expert witness for Johnson & Johnson. Dr. DeLancey declared no relevant financial relationships.

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fear of antibiotic overuse and frustration with physicians who prescribe them too freely are key sentiments expressed by women with recurrent urinary tract infections (rUTIs), according to findings from a study involving six focus groups.

“Here in our female pelvic medicine reconstructive urology clinic at Cedars-Sinai and at UCLA, we see many women who are referred for evaluation of rUTIs who are very frustrated with their care,” Victoria Scott, MD, Cedars-Sinai Medical Center, Los Angeles, said in an interview.

“So with these focus groups, we saw an opportunity to explore why women are so frustrated and to try and improve the care delivered,” she added.

Findings from the study were published online Sept. 1 in The Journal of Urology.

“There is a need for physicians to modify management strategies ... and to devote more research efforts to improving nonantibiotic options for the prevention and treatment of recurrent urinary tract infections, as well as management strategies that better empower patients,” the authors wrote.
 

Six focus groups

Four or five participants were included in each of the six focus groups – a total of 29 women. All participants reported a history of symptomatic, culture-proven UTI episodes. They had experienced two or more infections in 6 months or three or more infections within 1 year. Women were predominantly White. Most were employed part- or full-time and held a college degree.

From a qualitative analysis of all focus group transcripts, two main themes emerged:

• The negative impact of taking antibiotics for the prevention and treatment of rUTIs.
• Resentment of the medical profession for the way it managed rUTIs.

The researchers found that participants had a good understanding of the deleterious effects from inappropriate antibiotic use, largely gleaned from media sources and the Internet. “Numerous women stated that they had reached such a level of concern about antibiotics that they would resist taking them for prevention or treatment of infections,” Dr. Scott and colleagues pointed out.

These concerns centered around the risk of developing resistance to antibiotics and the ill effects that antibiotics can have on the gastrointestinal and genitourinary microbiomes. Several women reported that they had developed Clostridium difficile infections after taking antibiotics; one of the patients required hospitalization for the infection.

Women also reported concerns that they had been given an antibiotic needlessly for symptoms that might have been caused by a genitourinary condition other than a UTI. They also reported feeling resentful toward practitioners, particularly if they felt the practitioner was overprescribing antibiotics. Some had resorted to consultations with alternative practitioners, such as herbalists. “A second concern discussed by participants was the feeling of being ignored by physicians,” the authors observed.

In this regard, the women felt that their physicians underestimated the burden that rUTIs had on their lives and the detrimental effect that repeated infections had on their relationships, work, and overall quality of life. “These perceptions led to a prevalent mistrust of physicians,” the investigators wrote. This prompted many women to insist that the medical community devote more effort to the development of nonantibiotic options for the prevention and treatment of UTIs.
 

Improved management strategies

Asked how physicians might improve their management of rUTIs, Dr. Scott shared a number of suggestions. Cardinal rule No. 1: Have the patient undergo a urinalysis to make sure she does have a UTI. “There is a subset of patients among women with rUTIs who come in with a diagnosis of an rUTI but who really have not had documentation of more than one positive urine culture,” Dr. Scott noted. Such a history suggests that they do not have an rUTI.

It’s imperative that physicians rule out commonly misdiagnosed disorders, such as overactive bladder, as a cause of the patient’s symptoms. Symptoms of overactive bladder and rUTIs often overlap. While waiting for results from the urinalysis to confirm or rule out a UTI, young and healthy women may be prescribed a nonsteroidal anti-inflammatory drug (NSAID), such as naproxen, which can help ameliorate symptoms.

Because UTIs are frequently self-limiting, Dr. Scott and others have found that for young, otherwise healthy women, NSAIDs alone can often resolve symptoms of the UTI without use of an antibiotic. For relatively severe symptoms, a urinary analgesic, such as phenazopyridine (Pyridium), may soothe the lining of the urinary tract and relieve pain. Cystex is an over-the-counter urinary analgesic that women can procure themselves, Dr. Scott added.

If an antibiotic is indicated, those most commonly prescribed for a single episode of acute cystitis are nitrofurantoin and sulfamethoxazole plus trimethoprim (Bactrim). For recurrent UTIs, “patients are a bit more complicated,” Dr. Scott admitted. “I think the best practice is to look back at a woman’s prior urine culture and select an antibiotic that showed good sensitivity in the last positive urine test,” she said.

Prevention starts with behavioral strategies, such as voiding after sexual intercourse and wiping from front to back following urination to avoid introducing fecal bacteria into the urethra. Evidence suggests that premenopausal women who drink at least 1.5 L of water a day have significantly fewer UTI episodes, Dr. Scott noted. There is also “pretty good” evidence that cranberry supplements (not juice) can prevent rUTIs. Use of cranberry supplements is supported by the American Urological Association (conditional recommendation; evidence level of grade C).

For peri- and postmenopausal women, vaginal estrogen may be effective. It’s use for UTI prevention is well supported by the literature. Although not as well supported by evidence, some women find that a supplement such as D-mannose may prevent or treat UTIs by causing bacteria to bind to it rather than to the bladder wall. Probiotics are another possibility, she noted. Empathy can’t hurt, she added.

“A common theme among satisfied women was the sentiment that their physicians understood their problems and had a system in place to allow rapid diagnosis and treatment for UTI episodes,” the authors emphasized.

“[Such attitudes] highlight the need to investigate each patient’s experience and perceptions to allow for shared decision making regarding the management of rUTIs,” they wrote.
 

Further commentary

Asked to comment on the findings, editorialist Michelle Van Kuiken, MD, assistant professor of urology, University of California, San Francisco, acknowledged that there is not a lot of good evidence to support many of the strategies recommended by the American Urological Association to prevent and treat rUTIs, but she often follows these recommendations anyway. “The one statement in the guidelines that is the most supported by evidence is the use of cranberry supplements, and I do routinely recommended daily use of some form of concentrated cranberry supplements for all of my patients with rUTIs,” she said in an interview.

Dr. Van Kuiken said that vaginal estrogen is a very good option for all postmenopausal women who suffer from rUTIs and that there is growing acceptance of its use for this and other indications. There is some evidence to support D-mannose as well, although it’s not that robust, she acknowledged.

She said the evidence supporting the use of probiotics for this indication is very thin. She does not routinely recommend them for rUTIs, although they are not inherently harmful. “I think for a lot of women who have rUTIs, it can be pretty debilitating and upsetting for them – it can impact travel plans, work, and social events,” Dr. Van Kuiken said.

“Until we develop better diagnostic and therapeutic strategies, validating women’s experiences and concerns with rUTI while limiting unnecessary antibiotics remains our best option,” she wrote.

Dr. Scott and Dr. Van Kuiken have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.

“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.

“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”

MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.

However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.

Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.

To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.

However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.

The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.

“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.

One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.

“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.

Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”

“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.

Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.

And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.

“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.

The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.

However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.

Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.

“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.

“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”

In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.

The authors of the guidelines have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.