Effect of Pessary vs Surgery on Patient-Reported Improvement in Patients With Symptomatic Pelvic Organ Prolapse

Abstract

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

Success After Treatment of Pelvic Organ Prolapse With Surgery or Pessary Remains a Patient-Centered Choice

“…Most urogynecologists typically start with a ring pessary, followed by a Gellhorn pessary if the ring does not stay in place. However, in this RCT the ring pessary (spring mechanism) was essentially the only pessary fitted (96.8% of patients). This is a substantial limitation with regard to how often the pessaries were expelled since severe forms of POP (stages 3 and 4) more frequently require Gellhorn pessaries (space-occupying pessaries) .…”

“…The results are important for counseling women seeking initial treatment for POP, particularly when the optimal choice is not clear. The primary outcome of this trial was subjective improvement at 24 months as measured by Patient Global Impression of Improvement (PGI-I), a validated 7-point Likert scale that ranks responses to the question “what best describes how your post-operative condition is now, compared to how it was before you had surgery?” Subjective improvement was defined as much better or very much better on the PGI-I, which has been previously validated in patients undergoing treatment for POP . A key challenge for the trial was that patients often have preconceived expectations for their treatment.…”

“…Indeed, many individuals approached for enrollment wanted to choose their treatment option. For this reason, a parallel multicenter prospective comparative cohort study was performed simultaneously with the RCT …”

“…This is a substantial limitation with regard to how often the pessaries were expelled since severe forms of POP (stages 3 and 4) more frequently require Gellhorn pessaries (space-occupying pessaries) . Only 1 (0.5%) Gellhorn pessary was fitted in the trial, which may have led to decreased improvement in bulge symptoms or the severity of symptoms. However, benefits of the Gellhorn pessary may be offset by an inability to remain sexually active due to the space-occupying nature of this pessary …”

“…If a patient has uterine prolapse, vaginal hysterectomy alone is inadequate treatment. Unfortunately, the authors of the trial do not specify in their protocol how uterine prolapse was surgically managed consistently throughout all of the 22 clinical sites. Standardization of specific surgical techniques for the appropriate vaginal wall defect and/or hernia appears to be lacking.…”