Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse: A Randomized Clinical Trial

Abstract

Importance: Pelvic organ prolapse is a prevalent condition among women that negatively affects their quality of life. With increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase.

Objective: To investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.

Design, setting, and participants: The PEOPLE project was a noninferiority randomized clinical trial conducted in 21 participating hospitals in the Netherlands. A total of 1605 women with symptomatic stage 2 or greater pelvic organ prolapse were requested to participate between March 2015 through November 2019; 440 gave informed consent. Final 24-month follow-up ended at June 30, 2022.

Interventions: Two hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.

Main outcomes and measures: The primary outcome was subjective patient-reported improvement at 24 months, measured with the Patient Global Impression of Improvement scale, a 7-point Likert scale ranging from very much better to very much worse. This scale was dichotomized as successful, defined as much better or very much better, vs nonsuccessful treatment. The noninferiority margin was set at 10 percentage points risk difference. Data of crossover between therapies and adverse events were captured.

Results: Among 440 patients who were randomized (mean [SD] age, 64.7 [9.29] years), 173 (79.3%) in the pessary group and 162 (73.3%) in the surgery group completed the trial at 24 months. In the population, analyzed as randomized, subjective improvement was reported by 132 of 173 (76.3%) in the pessary group vs 132 of 162 (81.5%) in the surgery group (risk difference, -6.1% [1-sided 95% CI, -12.7 to ∞]; P value for noninferiority, .16). The per-protocol analysis showed a similar result for subjective improvement with 52 of 74 (70.3%) in the pessary group vs 125 of 150 (83.3%) in the surgery group (risk difference, -13.1% [1-sided 95% CI, -23.0 to ∞]; P value for noninferiority, .69). Crossover from pessary to surgery occurred among 118 of 218 (54.1%) participants. The most common adverse event among pessary users was discomfort (42.7%) vs urinary tract infection (9%) following surgery.

Conclusions and relevance: Among patients with symptomatic pelvic organ prolapse, an initial strategy of pessary therapy, compared with surgery, did not meet criteria for noninferiority with regard to patient-reported improvement at 24 months. Interpretation is limited by loss to follow-up and the large amount of participant crossover from pessary therapy to surgery.

Trial registration: Netherlands Trial Register Identifier: NTR4883.

Figure 1.. Study Population Randomized to Surgery or Pessary Therapy

^aThese women were included in the cohort “fitting failure.” ^bOne participant was excluded after randomization and excluded from all further analyses. ^cThe as-analyzed population and the per-protocol population were used to assess the primary outcome. The full analysis set contained the entire population, as randomized with their initially allocated treatment, irrespective of adherence. The per-protocol population consisted of all women randomized to pessary therapy who continued pessary use at 24 months and all women randomized to surgery without receiving additional treatment (ie, pessary or repeat surgery). Results based on the as-randomized population, as well as those based on the per-protocol population were used for the overall conclusion about noninferiority of pessary treatment as compared with surgery in this trial. ^dThe primary outcome was subjective improvement at 24 months, measured with the Patient Global Impression of Improvement (PGI-I), a validated single-item questionnaire ranging from very much better to very much worse on a 7-point Likert scale.

Figure 2.. Time to Additional Treatment or Reoperation

Colored shading indicates 95% CIs, and the vertical tick marks indicate patients who were censored. Pessary data indicate time to discontinuation of therapy or surgical intervention. Surgery data indicate time to repeat operation or start of additional use of pessary. The median failure observation time in the pessary group was 664 days (IQR, 131-730 days), and for the surgery group, it was beyond 730 days (right-sided censored IQR, 730-730 days).