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

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.