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Multicenter Study
. 2022 Apr;129(5):820-829.
doi: 10.1111/1471-0528.16950. Epub 2021 Oct 28.

Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study

L R van der Vaart  1 , A Vollebregt  2 , A L Milani  3 , A L Lagro-Janssen  4 , R G Duijnhoven  1 , J-Pwr Roovers  1   5 , C H Van der Vaart  6   7
Affiliations
Multicenter Study

Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study

L R van der Vaart et al. BJOG. 2022 Apr.

Abstract

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.

Keywords: Global improvement; pelvic organ prolapse; pessary; surgery.

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Figures

Figure 1
Figure 1
Kaplan–Meier plot for time to additional treatment or reoperation.
See this image and copyright information in PMC

Comment in

References

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