Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

Phase 3

Not yet recruiting

• Conditions: Pelvic Organ Prolapse (POP)
• Interventions: Drug: Vaginal Estrogen - Twice Weekly; Drug: Vaginal Estrogen - Daily

• Registration Number: NCT07030426
• Lead Sponsor: Queen's University

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.

Detailed Description

Multi-center, randomized, open-label, parallel-group, feasibility-controlled trial

The intervention is the use of vaginal estrogen for 6 weeks after pelvic organ prolapse surgery. Participants will be randomized into 3 groups:

1. No vaginal estrogen

2. Vaginal estrogen 2 times per week

3. Vaginal estrogen daily

Participants may be enrolled after diagnosis of pelvic organ prolapse and decision to proceed with surgery. Participants will be seen for a randomization visit within 6 weeks of their scheduled surgery. The intervention lasts from the day of surgery until 6 weeks after surgery. Participants will be seen for a post-operative follow-up visit at 6 weeks, and study follow-up visits at 6 months, 1 year and 2 years.

Sample Size: N=60 in each group, for a total of N=180 participants. For this pilot trial, we will recruit approximately 15% of the sample size required for the full-scale trial. Data from this pilot trial will be used to adjust the event rate in the sample size calculation for the full trial, if needed. Our sample size accounts for a non-compliance rate of 5% and a loss to follow-up rate of 5%.

After enrollment, participants will complete a baseline questionnaire that collects information on demographics and health history. This may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.

After enrollment, a study investigator or delegate will complete a case report for that collects additional information on the participant's pregnancy and pelvic health history.

At each study visit, a study investigator or delegate will complete a case report form that captures any changes in the participant's health history since the previous visit.

At all post-surgical visits, a study investigator or delegate will collect information in these same case report forms on complications and treatment failure. The questions in these case report forms will be administered verbally, with verification through chart review as appropriate or as needed.

At each study visit a Pelvic Organ Prolapse Quantification (POP-Q) and Visual Analog Scale (VAS) on GSM symptoms assessment will be completed by a study investigator or medical learner under direct supervision of a study investigator. As well, height, weight and blood pressure will be measured. If any of these are collected/done for clinical reasons at the same visit, the clinically collected data will be used for study purposes. The measurements and assessments will not be repeated for study purposes.

At each study visit the Prolapse Quality of Life Questionnaire (P-QOL) and incontinence questionnaires including the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), the Incontinence Impact Questionnaire Short Form (IIQ-7), and the Urogenital Distress Inventory Short Form (UDI-6) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.

At the 6 week and 6 month post-surgical visit the Surgical Satisfaction Questionnaire (SSQ-8) will be administered. These may be completed online via an email link sent through REDCap, in person on a hard copy questionnaire, or the questions can be administered verbally by study staff.

At the 6 week post-surgical visit adherence to the study intervention will be assessed through collection of study product diaries and by querying participants on vaginal estrogen usage in the intervention period.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-26
• Study Start: 2025-10-01
• Primary Completion: 2027-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Twice Weekly Vaginal Estrogen Group	Vaginal Estrogen - Twice Weekly	Twice Weekly Vaginal Estrogen
Daily Vaginal Estrogen Group	Vaginal Estrogen - Daily	Daily Vaginal Estrogen

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Loss to Follow Up Rate - 1 year	1 year post surgery	Loss to follow up rates at each of the study end points measured as n/N (%).
Prolapse Quality of Life - 2 years	2 years post surgery	The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Loss to Follow Up Rate - 6 months	6 Months post surgery	Loss to follow up rates at each of the study end points measured as n/N (%).
Complications - 6 weeks	6 weeks post surgery	A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Complications - 6 months	6 months post surgery	A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Treatment Failure - 1 year	1 year post surgery	A composite measure of the incidence of mesh erosion and treatment failure.
Treatment Failure - 2 years	2 years post surgery	A composite measure of the incidence of mesh erosion and treatment failure.
Loss to Follow Up Rate - 2 years	2 years post surgery	Loss to follow up rates at each of the study end points measured as n/N (%).
Patient Satisfaction - 6 weeks	6 weeks post surgery	Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied).
Patient Satisfaction - 6 months	6 months post surgery	Patient satisfaction will be assessed using the Surgical Satisfaction Questionnaire (SSQ-8). This questionnaire measures satisfaction with the surgical procedure on a scale from 8 (most satisfied) to 40 (least satisfied).
GSM Symptoms - 6 weeks	6 weeks post surgery	GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
GSM Symptoms - 6 months	6 weeks post surgery	GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
GSM Symptoms - 1 year	1 year post surgery	GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
GSM Symptoms - 2 years	2 years post surgery	GSM symptoms will be assessed using the Visual Analog Scale (VAS) on GSM symptoms. It assesses 5 symptoms (dryness, itching, burning, dyspareunia, and dysuria) on a scale from 0 - 10, from no symptoms to severe symptoms.
Prolapse Quality of Life - 6 weeks	6 weeks post surgery	The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Prolapse Quality of Life - 6 months	6 months post surgery	The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.
Prolapse Quality of Life - 1 year	1 year post surgery	The impact of pelvic organ prolapse on the participant's quality of life will be assessed using the Prolapse Quality of Life Questionnaire (P-QOL). The P-QOL questionnaire is a self-reported tool that contains 20 questions representing nine quality of life domains: general health, prolapse impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy and severity measures. Scores in each domain range from 0 to 100. Higher scores indicate a greater impairment of quality of life, and lower scores indicate a good quality of life.

Trial Locations

Locations (2)

Health Sciences Centre; 🇨🇦 St John's, Newfoundland and Labrador, Canada

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada