BJOG : an international journal of obstetrics and gynaecology · 2026
Vaginal Oestrogen Therapy for Postmenopausal Women Undergoing Prolapse Surgery: A Multicentre Double-Blind Randomised Placebo-Controlled Clinical Trial.
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Vodegel Eva V, van Rest Krista, Speksnijder Leonie, Vollebregt Astrid, Adriaanse Albert, Roos Eveline J, Gerards Franca, Spaans Wilbert, Sikkema Marko, Veen Joggem, Vernooij Flora, van der Ploeg Marinus, Roovers Jan-Paul W R, EVA Study Group
Аннотация
OBJECTIVE: To determine whether vaginal oestrogen therapy improves outcomes after prolapse surgery in postmenopausal women.
DESIGN: Double-blind, randomised, placebo-controlled trial with 12 month follow-up.
SETTING: Multicentre, 22 hospitals in the Netherlands.
POPULATION: Postmenopausal women with POP-Q stage ≥ 2 scheduled for primary native-tissue prolapse repair.
METHODS: Women were randomised (1:1) to vaginal oestriol cream (1 mg/g) or identical placebo, started 4-6 weeks preoperatively and continued to 12 months postoperatively (twice-weekly maintenance).
MAIN OUTCOME MEASURE: Subjective improvement in prolapse symptoms at 12 months postoperatively, defined as "much" or "very much" improved on the Patient Global Impression of Improvement (PGI-I) scale.
RESULTS: In total 293 women participated, 57 women dropped out. At 12 months, 92% of women in the oestrogen group versus 80% in the placebo group reported improvement on the PGI-I scale (p = 0.02). Pelvic floor-related quality of life was better in the oestrogen group (median score PFDI-20: 17 vs. 25, p = 0.03), and fewer women reported discomfort/pain (EQ-5D-5L: 61% vs. 77%, p = 0.04). Anatomical outcomes, composite surgical success, sexual function and reintervention rates did not differ between groups. The cream was easy to use; 80% would use it for 1 year if it provided meaningful health benefits.
CONCLUSIONS: Perioperative vaginal oestrogen improved patient-reported outcomes and pelvic floor-related quality of life at 12 months, without affecting anatomical outcomes. These findings support discussing vaginal oestrogen as an adjunctive treatment option in shared decision-making with postmenopausal women undergoing primary prolapse surgery.
TRIAL REGISTRATION: NL-OMON55535, https://www.onderzoekmetmensen.nl/en/trial/55535.
DESIGN: Double-blind, randomised, placebo-controlled trial with 12 month follow-up.
SETTING: Multicentre, 22 hospitals in the Netherlands.
POPULATION: Postmenopausal women with POP-Q stage ≥ 2 scheduled for primary native-tissue prolapse repair.
METHODS: Women were randomised (1:1) to vaginal oestriol cream (1 mg/g) or identical placebo, started 4-6 weeks preoperatively and continued to 12 months postoperatively (twice-weekly maintenance).
MAIN OUTCOME MEASURE: Subjective improvement in prolapse symptoms at 12 months postoperatively, defined as "much" or "very much" improved on the Patient Global Impression of Improvement (PGI-I) scale.
RESULTS: In total 293 women participated, 57 women dropped out. At 12 months, 92% of women in the oestrogen group versus 80% in the placebo group reported improvement on the PGI-I scale (p = 0.02). Pelvic floor-related quality of life was better in the oestrogen group (median score PFDI-20: 17 vs. 25, p = 0.03), and fewer women reported discomfort/pain (EQ-5D-5L: 61% vs. 77%, p = 0.04). Anatomical outcomes, composite surgical success, sexual function and reintervention rates did not differ between groups. The cream was easy to use; 80% would use it for 1 year if it provided meaningful health benefits.
CONCLUSIONS: Perioperative vaginal oestrogen improved patient-reported outcomes and pelvic floor-related quality of life at 12 months, without affecting anatomical outcomes. These findings support discussing vaginal oestrogen as an adjunctive treatment option in shared decision-making with postmenopausal women undergoing primary prolapse surgery.
TRIAL REGISTRATION: NL-OMON55535, https://www.onderzoekmetmensen.nl/en/trial/55535.