Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery (NCT07030426) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
Canada180 participantsStarted 2025-10-01
Plain-language summary
This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
✓. The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.
✓. Age ≥18 years at the time of consent.
✓. Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.
✓. Primary or recurrent prolapse surgery without a history of mesh surgery.
✓. Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.
✓. Plans to reside in the study area for at least 2 years after their surgery.
Exclusion criteria
✕. Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
✕. Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:
✕. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.
✕. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.