TUCSON, ARIZ. — A randomized crossover trial suggests that symptom relief and satisfaction can be obtained by either of two commonly used pessary types, but that patient selection and patience are both key to success.
The multicenter study enrolled 134 women ages 30–89 (mean age 61) with symptomatic pelvic organ prolapse. They were randomized to be fitted with one of two types of pessary and to wear it, if possible, for 3 months before being switched to the other pessary design for 3 months.
Subjects could discontinue the use of either pessary at any time.
Indeed, only 62 of 134 subjects stayed in the study long enough to complete satisfaction scores on both types of pessaries and of those, just 22 were highly satisfied with both.
“Some could not be fitted. Some didn't like pessaries. Some had had enough of pessaries after one trial.
“The message I got was that pessaries aren't really for everyone. They really are for a subset of patients,” said Dr. Geoffrey W. Cundiff, professor of obstetrics and gynecology at Johns Hopkins School of Medicine in Baltimore.
Surprisingly, younger women were far less likely than their older counterparts to complete the trial comparing a ring pessary with support and a gellhorn pessary, reported Dr. Cundiff at the annual meeting of the Society of Gynecologic Surgeons.
Satisfaction rates were similar for the two pessary types, but there was a clear difference in the types of patients who preferred each design.
The 36 women who reported high satisfaction with the ring pessary were older and had weaker pelvic floor muscles. They were more likely to be nonwhite and to be more parous than those who preferred the gellhorn pessary.
Meanwhile, the 39 women who strongly preferred the gellhorn pessary were more likely to have anterior wall prolapse and less likely to have had a hysterectomy or prior prolapse surgery.
Refusal to wear a pessary for 3 months was significantly more common among younger women (mean age 57, compared with 66) and nonwhite women. The nine subjects who wore the pessaries but were dissatisfied with both were more likely to be white, have a history of prior prolapse surgery, and have stage II prolapse.
A subanalysis of the data demonstrated that patients who wore either pessary for 3 months experienced a significant reduction in lower urinary tract symptoms, particularly obstructive symptoms.
Among 97 patients who completed the Pelvic Floor Distress Inventory, no differences were seen in symptomatic relief offered by the ring or gellhorn pessaries, reported Dr. Joseph I. Schaffer, chief of gynecology at the University of Texas Southwestern Medical Center in Dallas.
Scores on the Obstructive/Discomfort subscale declined from a mean 20.32 at baseline to 8.61. Irritative subscale scores declined from a baseline mean of 15.85 to 10, and Stress subscale scores declined from 15.55 at baseline to 12.24.
On another measure, the Urinary Distress Inventory, scores improved from a baseline mean of 51.31 to 31.45.
“This study challenges commonly held beliefs regarding pessaries,” said Dr. Cundiff, and audience members agreed.
One attendee, Dr. Marc Toglia of Philadelphia, admitted the results “challenge my belief system.”
Both physicians acknowledged their surprise that so many women would find the gellhorn pessary preferable to a ring pessary, particularly if they had anterior wall prolapse.
A formal discussant on the study, Dr. Deborah Myers of Brown University School of Medicine in Providence, R.I., took note of the fact that a third of the patients required refitting of a pessary.
“This is important information for patients and physicians,” she said. “Don't give up on the first try.”