Vaginal estrogen after pelvic organ prolapse surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized trial tests three regimens of vaginal estrogen for six weeks after POP repair. About 180 participants (60 per group) will be enrolled across two centers and followed at 6 weeks, 6 months, 1 year, and 2 years to assess feasibility, adherence, safety, and patient-reported outcomes. The study will help refine the design for a full-scale trial by focusing on recruitment rates and preliminary outcome signals. Eligibility includes adults undergoing apical suspension for POP at participating sites with planned follow-up for two years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Kingston Health Sciences Centre
  Kingston, Ontario, Canada Recruiting
• Health Sciences Centre
  St. John's, Newfoundland and Labrador, Canada Not yet recruiting

Study contacts

• Principal investigator: Sarah Wozney, MD, MScHQ — Queen's University
• Study coordinator: Jessca Pudwell, MPH, MSc
• Email: jessica.pudwell@queensu.ca
• Phone: 613-549-6666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Risk predictor for new urinary incontinence after prolapse surgery

  This study tests a model to predict which women might develop new stress urinary incontinence after pelvic organ prolapse repair.

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• Comparing the Manchester procedure versus vaginal hysterectomy for uterine prolapse

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• Poly-L-lactic acid injections for vulvovaginal tissue regeneration

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  Recruiting Duke University · Durham, North Carolina · NCT07544667

• Pelvic floor mesh used in laparoscopic sacrocolpopexy to repair pelvic organ prolapse

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  Recruiting A.M.I. Agency for Medical Innovations GmbH · Wiener Neustadt, Lower Austria and 3 other locations · NCT07497321

• Paracervical block for pain control after vNOTES uterosacral ligament suspension

  This will test whether a paracervical injection of bupivacaine reduces early postoperative pain in women having vNOTES uterosacral ligament suspension for pelvic organ prolapse.

  Recruiting Bakirkoy Dr. Sadi Konuk Research and Training Hospital · Istanbul, Istanbul · NCT07440576

• Postpartum pelvic floor recovery and early rehabilitation after vaginal birth

  This project tests whether early, individualized pelvic floor muscle training starting 2–3 weeks after a vaginal birth helps people with postpartum pelvic floor symptoms recover better than usual care.

  Recruiting at 2 sites Vastra Gotaland Region · Gothenburg and 1 other locations · NCT07430865

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.