Pelvic organ prolapse surgery vs. pessary treatment yields greater improvements

Compared with pessary therapy, women who underwent surgery for symptomatic pelvic organ prolapse reported greater subjective improvement and sexual well-being, according to 1-year interim results of a randomized controlled trial.

“Pelvic organ prolapse is a common problem among women, and with an increasing life expectancy, the impact will increase worldwide,” Lisa van der Vaart, MD, a PhD candidate at Amsterdam University Medical Center in the Netherlands, said in a presentation at the American Urogynecologic Society and International Urogynecological Association (IUGA) Scientific Meeting. “Therefore, information on the reduction of bothersome prolapse complaints of either strategy” — pessary or surgery — “offers valuable information for counseling patients.”

Van der Vaart and colleagues conducted a noninferiority, multicenter study of 439 women who had symptomatic pelvic organ prolapse (POP) stage 2 or greater who had a successful pessary fitting. The researchers randomly assigned patients to either pessary (n = 218; 49.7%) or surgery (n = 221; 50.3%). They reported results halfway through the 2-year study.

Subjective improvement

For their analysis of subjective improvement, the researchers evaluated responses to the Patient Global Impression of Improvement (PGI-I) questionnaire, defining improvement as “very much” or “much improvement.” They also evaluated how bothersome symptoms were, adverse events and switches in between surgery and pessary.

Intention-to-treat PGI-I scores revealed that 75.9% of women in the pessary group reported subjective improvement, compared with 82.3% of those in the surgery group (risk difference, –6.3%; 90% CI, –13.3% to –0.6%). The per-protocol scores showed that 67.3% of women in the pessary group and 84.8% of those in the surgery group had subjective improvement (risk difference, –17.5%; 90% CI, –26.1% to –8.8%).

As for secondary outcomes, women in the surgery group achieved significantly greater reductions in Urogenital Distress Inventory Short Form (UDI-6) scores (mean difference, 5.64; 95% CI, 0.47-10.55) and Pelvic Floor Distress Inventory (PFDI) scores (mean difference, 11.31; 95% CI, 1.07-21.38) for the per-protocol analysis only. There were no significant differences in the intention-to-treat outcomes.

“We saw that after 12 months, 47.1% of women in our study discontinued with pessary treatment, and that 44% of women switched to surgical intervention,” van der Vaart said. “The most common reasons for the switch were pessary expulsion and discomfort.”

In the surgery group, only two (0.9%) women added pessary to their treatment and seven (3.2%) women had a second surgery to address recurrent prolapse, van der Vaart said.

“Since this is a randomized controlled trial consisting of women who do not have a treatment preference, the results need to be interpreted likewise,” van der Vaart said. “Based on these interim results, women can be counseled that surgery offers greater chance of subjective improvement ... However, we also have to keep in mind that if we look at women who start with pessary therapy, approximately 70% of patients still continue at 12 months and consider themselves improved.”

Sexual well-being

For their analysis of sexual well-being — the results of which were presented in a second presentation — van der Vaart and colleagues evaluated scores on the POP/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR). Higher PISQ-IR scores indicated better sexual functioning in women who were sexually active and greater POP impact on sexual inactivity in women who were sexually inactive.

The researchers also took note of changes in sexual activity status and de novo dyspareunia.

In the intention-to-treat analysis, PISQ-IR scores indicated that sexually active women in the surgery group experienced significant improvement in the condition impact score (mean difference, –0.29; 95% CI, –0.47 to –0.1) and the overall score (mean difference, –0.08; 95% CI, –0.17 to –0.01) compared with women in the pessary group.

The per-protocol analysis revealed that sexually active women who underwent surgery also had significantly more improvement in their condition impact scores (mean difference, –0.32; 95% CI, –0.57 to –0.09) and their overall scores (mean difference, –0.13; 95% CI, –0.23 to –0.03) compared with sexually active women in the pessary group.

There were no significant differences in PISQ-IR scores between the surgery and pessary groups for sexually inactive women.

Although there were slight differences in sexual status change, de novo dyspareunia and persistent dyspareunia between the pessary and surgery groups, the researchers found that they were not significant.

“Concluding from these interim results, we saw that sexually active women who clearly expressed that prolapse-related symptoms limit their sexual functioning should be counseled that surgery results in a more remarkable improvement,” van der Vaart said.

References:

• Van der Vaart L, et al. Abstract 13. Presented at: American Urogynecologic Society and International Urogynecological Association Scientific Meeting; June 14-18, 2022; Austin, Texas (hybrid meeting).
• Van der Vaart L, et al. Abstract 117. Presented at: American Urogynecologic Society and International Urogynecological Association Scientific Meeting; June 14-18, 2022; Austin, Texas (hybrid meeting).