Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

NCT07030426 | Not Yet Recruiting Phase 3

• 1 other identifier: Ref: No 70577
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pelvic Organ Prolapse (POP)

Keywords

pelvic organ prolapse; vaginal estrogen; pelvic organ prolapse surgery; pelvic organ prolapse repair

Outcome Measures

Primary Outcomes (1)

• Recruitment Rate

  For the primary feasibility outcome, the trial will be considered feasible if at least 75% of the target sample can be recruited in 12 months.

  12 months

Secondary Outcomes (17)

• Loss to Follow Up Rate - 6 months

  6 Months post surgery

• Loss to Follow Up Rate - 1 year

  1 year post surgery

• Loss to Follow Up Rate - 2 years

  2 years post surgery

• Patient Satisfaction - 6 weeks

  6 weeks post surgery

• Patient Satisfaction - 6 months

  6 months post surgery

Other Outcomes (1)

• Adherence

  6 weeks post surgery

Study Arms (3)

No Vaginal Estrogen Group

NO INTERVENTION

No vaginal estrogen

Twice Weekly Vaginal Estrogen Group

ACTIVE COMPARATOR

Twice Weekly Vaginal Estrogen

Drug: Vaginal Estrogen - Twice Weekly

Daily Vaginal Estrogen Group

ACTIVE COMPARATOR

Daily Vaginal Estrogen

Drug: Vaginal Estrogen - Daily

Interventions

Vaginal Estrogen - Twice Weekly DRUG

Twice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime .

Also known as: Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream

Twice Weekly Vaginal Estrogen Group

Vaginal Estrogen - Daily DRUG

Daily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime.

Also known as: Conjugated Estrogens CSD, 0.625 mg/g, Vaginal Cream

Daily Vaginal Estrogen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Any individual meeting any of the following criteria is not eligible for participation in this study:
• Participant undergoing anterior and/or posterior repair only (no apical prolapse repair).
• Participant undergoing obliterative procedures.
• Participant with a history of mesh surgery for prolapse.
• Participant undergoing uterine sparing surgery.
• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (2)

Health Sciences Centre

St. John's, Newfoundland and Labrador, A1B 3X5, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L2V7, Canada

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Vaginal Creams, Foams, and Jellies

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Feminine Hygiene Products; Equipment and Supplies

Study Officials

• Sarah Wozney, MD, MScHQ

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessca Pudwell, MPH, MSc

CONTACT

613-549-6666; jessica.pudwell@queensu.ca

Kira King

CONTACT

613-549-6666; kira.king@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 15 years after the study results are published.
• Access Criteria: The data and data dictionary from the study REDCap database will be made available in a public data archive such as the Queen's University Library Research Data Archive in the Scholars Portal Dataverse.

Locations

CA (2)