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Published on: October 25, 2024
Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study
L R van der Vaart1, A Vollebregt2, A L Milani3
1Department of Obstetrics and Gynaecology, Amsterdam Reproduction & Development Research Institute, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
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.
