Vaginal Oestrogen Therapy for Postmenopausal Women Undergoing Prolapse Surgery: A Multicentre Double‐Blind Randomised Placebo‐Controlled Clinical Trial

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Publication Details

Journal
BJOG An International Journal of Obstetrics & Gynaecology
Published
2026-08-28
DOI
https://doi.org/10.1111/1471-0528.70311
Primary Topic
Pelvic floor disorders treatments
Type
article
Field-Weighted Citation Impact
0.00

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article

Vaginal Oestrogen Therapy for Postmenopausal Women Undergoing Prolapse Surgery: A Multicentre Double‐Blind Randomised Placebo‐Controlled Clinical Trial

Krista L.C. van Rest, J. Marinus van der Ploeg, Astrid Vollebregt, Albert Adriaanse et al.
BJOG An International Journal of Obstetrics & Gynaecology
Pelvic floor disorders treatments
article

Vaginal Oestrogen Therapy for Postmenopausal Women Undergoing Prolapse Surgery: A Multicentre Double‐Blind Randomised Placebo‐Controlled Clinical Trial

Krista L.C. van Rest, J. Marinus van der Ploeg, Astrid Vollebregt, Albert Adriaanse, Leonie Speksnijder, Jan‐Paul Roovers, Eva V. Vodegel, Eveline J Roos, J.P.W. van der Veen, Flora Vernooij, Wilbert Spaans, Franca Gerards, the EVA Study Group, Marko Sikkema
article en

Abstract

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.

BJOG An International Journal of Obstetrics & Gynaecology
Radboud University Nijmegen (NL), Maastricht University Medical Centre (NL), Noordwest Ziekenhuisgroep (NL), Spaarne Ziekenhuis (NL), Bergman Clinics (NL), Amphia Ziekenhuis (NL), Diakonessenhuis hospital (NL), Martini Ziekenhuis (NL), Flevoziekenhuis (NL), Máxima Medisch Centrum (NL), Tergooi (NL), Ziekenhuis Groep Twente (NL), Amsterdam University Medical Centers (NL), University of Amsterdam (NL)
ZonMw, Aspen
Gender equality
Openalex Percentile: Top 9%
Pelvic floor disorders treatments
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