Vaginal Oestrogen Therapy for Postmenopausal Women Undergoing Prolapse Surgery: A Multicentre Double-Blind Randomised Placebo-Controlled Clinical Trial
Perioperative vaginal estrogen improved patient-reported recovery, but not anatomic prolapse outcomes.
*Multicentre double-blind randomized controlled trial; Level 1b (OCEBM).
Citation
Vodegel EV, van Rest K, Speksnijder L, et al. Vaginal oestrogen therapy for postmenopausal women undergoing prolapse surgery. BJOG. 2026;0:1-9. doi:10.1111/1471-0528.70311
Background
Prolapse surgery often improves symptoms, but recurrence and persistent symptoms remain common. Vaginal estrogen may improve vaginal tissue quality and healing, but prior evidence was limited.
Patients
Postmenopausal women with stage 2 or greater pelvic organ prolapse scheduled for first native-tissue prolapse repair. Exclusions included prior same-compartment prolapse surgery, mesh repair, recent estrogen use, vaginal infection, estrogen-dependent cancer, or estrogen contraindication.
Intervention
Vaginal estriol cream, started 4–6 weeks before surgery and continued twice weekly to 12 months after surgery.
Control
Identical placebo cream.
Outcome
Primary outcome: “much” or “very much” improved prolapse symptoms on the Patient Global Impression of Improvement scale.
Follow-up Period
12 months after surgery.
Results
| Outcome | Estrogen | Placebo | Effect | NNT |
|---|---|---|---|---|
| Symptom improvement at 12 months (primary) | 91.5% | 79.8% | OR 2.73 (95% CI 1.18 to 6.28) | 9 |
| No discomfort or pain | 77.1% | 60.6% | OR 2.2 (95% CI 1.2 to 4.0) | 7 |
| Pelvic-floor symptom score | Better | Worse | Median difference 8.3 points (CI not reported) | — |
OR = odds ratio; CI = confidence interval; NNT = number needed to treat.
Analyses were intention-to-treat, with similar per-protocol findings. Anatomic prolapse outcomes, composite surgical success, sexual function, complications, and repeat treatment did not differ. The control was placebo, not another active treatment.
Limitations
Dropout was higher than expected, reducing precision. Follow-up was only 12 months, so long-term recurrence is unknown. The primary improvement was statistically significant but smaller than the prespecified 15% clinically relevant difference.
Funding
Dutch grant; Aspen Pharmacare supplied creams. No apparent reporting control.
Clinical Application
Discuss vaginal estrogen as an optional adjunct after prolapse surgery; it may improve symptoms, but should not be promised to prevent recurrence.
Discussion
Sign in to join the discussion.
In this double-blind RCT, perioperative vaginal oestriol improved subjective prolapse symptom improvement at 12 months (92% vs 80%; OR 2.7) but not anatomical success or reintervention. Are these patient-reported benefits valid and applicable enough to change shared decision-making? In this RCT, 92% of women receiving perioperative vaginal oestriol versus 80% receiving placebo reported “much” or “very much” improvement in prolapse symptoms at 12 months. Which statement best describes the absolute treatment effect?