Dataset Information

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

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.

SUBMITTER: van der Vaart LR

PROVIDER: S-EPMC9298049 | biostudies-literature |

REPOSITORIES: biostudies-literature

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