Pessary or Surgery for a Symptomatic Pelvic Organ Prolapse, PEOPLE study: A Multicenter Prospective Cohort Study.

Abstract

OBJECTIVE\nTo compare the 24-months efficacy of pessary or surgery as primary treatment for symptomatic pelvic organ prolapse (POP).\n\n\nDESIGN\nMulticenter prospective comparative cohort study.\n\n\nSETTING\nTwenty-two Dutch hospitals.\n\n\nSTUDY POPULATION\nWomen referred with symptomatic POP stage ≥ 2 and moderate to severe POP symptoms.\n\n\nMETHODS\nThe primary outcome was subjective improvement at 24-months 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 cross-over between therapies. The primary safety outcome was the occurrence of adverse events.\n\n\nMAIN OUTCOME MEASUREMENT\nPGI-I at 24-months.\n\n\nRESULTS\nWe included 539 women, 335 (62.2%) in the pessary arm and 204 (37.8%) in the surgery arm. After 24-months, subjective improvement was reported by 134 (83.8%) women in the surgery group as compared to 180 (74.4%) in the pessary group (risk difference 9.4%; 95% confidence-interval, 1.4 - 17.3; p<0.01). Seventy-nine (23.6%) women switched from pessary to surgery and 22 (10.8%) women in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (p≤0.01) and reduction in the perceived severity of symptoms (p≤0.001) compared to baseline.\n\n\nCONCLUSION\nSignificantly more women in the surgery group reported subjective improvement after 24-months. Both therapies however, showed a clinically significant relieve of prolapse symptoms.