ImportancePelvic 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.ObjectiveTo investigate whether treatment with a pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse.Design, Setting, and ParticipantsThe 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.InterventionsTwo hundred eighteen participants were randomized to receive pessary treatment and 222 to surgery.Main Outcomes and MeasuresThe 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.ResultsAmong 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 RelevanceAmong 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 RegistrationNetherlands Trial Register Identifier: NTR4883

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Objective To compare the 24‐month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). Design Multicentre prospective comparative cohort study. Setting Twenty‐two Dutch hospitals. Population Women referred with symptomatic POP of stage ≥2 and moderate‐to‐severe POP symptoms. Methods The primary outcome was subjective improvement at the 24‐month follow‐up according to the Patient Global Impression of Improvement (PGI‐I) scale. Secondary outcomes included improvement in prolapse‐related symptoms measured with the Pelvic Floor Distress Inventory (PFDI‐20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI‐S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. Main outcome measure PGI‐I at 24 months. Results We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4–17.3%, P < 0.01). Seventy‐nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. Conclusions Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. Tweetable abstract Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.