Can a cream improve recovery after prolapse surgery?
NCT ID NCT07030426
First seen Aug 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This trial tests whether using vaginal estrogen cream for six weeks after pelvic organ prolapse repair surgery improves recovery. Participants are randomly assigned to no estrogen, estrogen twice weekly, or estrogen daily. The study tracks satisfaction, menopausal symptoms, complications, and how well people stick to the treatment. It also checks whether a larger study is feasible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vaginal estrogen cream (conjugated estrogens)
- What this could lead to
- If it works, this could point toward a simple way to improve recovery and satisfaction after prolapse surgery.
- What could go wrong
- This is a small pilot trial focused on feasibility, so results may not be conclusive. Vaginal estrogen can cause local irritation or bleeding.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Participants must meet all the following inclusion criteria to be eligible for enrollment into the study: 1. Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol. 2. The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures. 3. Age ≥18 years at the time of consent. 4. Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers. 5. Primary or recurrent prolapse surgery without a history of mesh surgery. 6. Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function. 7. Plans to reside in the study area for at least 2 years after their surgery. Exclusion Criteria Any individual meeting any of the following criteria is not eligible for participation in this study: 1. Participant undergoing anterior and/or posterior repair only (no apical prolapse repair). 2. Participant undergoing obliterative procedures. 3. Participant with a history of mesh surgery for prolapse. 4. Participant undergoing uterine sparing surgery. 5. Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator: * Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container. * Liver dysfunction or disease as long as liver function tests have failed to return to normal. * Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer). * Endometrial hyperplasia. * Known, suspected, or past history of breast cancer. * Undiagnosed abnormal genital bleeding. * Known or suspected pregnancy * Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease). * Partial or complete loss of vision due to ophthalmic vascular disease. * Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies). 6. 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. 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Health Sciences Centre
NOT_YET_RECRUITINGSt. John's, Newfoundland and Labrador, A1B 3X5, Canada
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Kingston Health Sciences Centre
RECRUITINGKingston, Ontario, K7L2V7, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple stitch reduce repeat prolapse surgery?
- Can a new mesh implant fix pelvic organ prolapse better?
- New study tests which surgery works best for rectal prolapse in women
- Large study to track bladder leaks after prolapse surgery in over 1,000 women
- New drug could replace opioids for Post-Surgery pain
- New study aims to predict bladder control problems after pelvic surgery