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

A symptomatic pelvic organ prolapse is a condition among women that can cause bothersome complaints. With an increasing life expectancy, the global need for cost-effective care for women with pelvic organ prolapse will continue to increase. We initiated this randomized controlled trial, investigating whether treatment with pessary is noninferior to surgery among patients with symptomatic pelvic organ prolapse two years after initiation of treatment. This trial included 440 women.

The primary outcome was subjective patient-reported improvement at 2 years follow-up, measured with the Patient Global Impression of Improvement (PGI-I). This scale was dichotomized into successful, defined as much or very much better, vs non successful treatment. The noninferiority margin was set at 10 percentage points risk difference. Cross-over between therapies and adverse events were among the secondary outcomes.

A total of 173 (79.3%) patients in the pessary group and 162 (73.3%) patients in the surgery group completed the trial at 2 years follow-up. 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.

To conclude, an initial strategy of pessary therapy, compared with surgery, among patients with a symptomatic pelvic organ prolapse did not meet the criteria for noninferiority. Especially for women without a predetermined treatment preference, the chance to switch from pessary to surgery is high (50%).