A Phase 3 interventional study of Vaginal Estrogen - Twice Weekly and Vaginal Estrogen - Daily in Pelvic Organ Prolapse (POP), sponsored by Sarah Wozney. Recruiting at 2 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Sarah Wozney · Phase 3, Interventional, and Treatment
Among 19 studies in Pelvic Organ Prolapse with a site in Canada — 2 open to participants now, 3 under way, 1 of them phase 3. Pelvic Organ Prolapse · Canada.
Among the 19 studies in Pelvic Organ Prolapse with a site in Canada, this one is the 3rd largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2026, is one of 4 in phase 3, and was the 19th registered.
521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.
Browse Pelvic Organ Prolapse studies →2 of the 19 studies in Pelvic Organ Prolapse with a site in Canada are open now. Recruiting first, the newest first:
University of Alberta · Sites in Canada
Ages 18+ · Women only
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 53 Pelvic Organ Prolapse studies recruiting now, 31 (58%) set no upper age limit and 10 (19%) stop at 75 or younger; 2 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 180 is above the median of 80 across 336 interventional studies indexed under Pelvic Organ Prolapse.
Median enrollment 50 across the 13 interventional studies, 235 across the 6 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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3 of 19 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Sarah Wozney as lead sponsor.
Sarah Wozney has 1 study filed under Pelvic Organ Prolapse — fewer than ten, so there is no comparison to draw.
2 of the studies in Pelvic Organ Prolapse with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07030426Phase 3Sarah WozneyVaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery | 2027-09-30 |
| NCT02965313University of British ColumbiaComposite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial | 2026-11 |
Add all 2 to your calendar (.ics) → With an account.
Among the 19 studies in Pelvic Organ Prolapse with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria
Any individual meeting any of the following criteria is not eligible for participation in this study:
Participant with a to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No vaginal estrogen
Twice Weekly Vaginal Estrogen
Drug: Vaginal Estrogen - Twice Weekly
Daily Vaginal Estrogen
Drug: Vaginal Estrogen - Daily
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
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
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.
Time frame: 12 months
Loss to Follow Up Rate - 6 months
Loss to follow up rates at each of the study end points measured as n/N (%).
Time frame: 6 Months post surgery
Loss to Follow Up Rate - 1 year
Loss to follow up rates at each of the study end points measured as n/N (%).
Time frame: 1 year post surgery
Loss to Follow Up Rate - 2 years
Loss to follow up rates at each of the study end points measured as n/N (%).
Time frame: 2 years post surgery
Patient Satisfaction - 6 weeks
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).
Time frame: 6 weeks post surgery
Patient Satisfaction - 6 months
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).
Time frame: 6 months post surgery
GSM Symptoms - 6 weeks
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.
Time frame: 6 weeks post surgery
GSM Symptoms - 6 months
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.
Time frame: 6 weeks post surgery
GSM Symptoms - 1 year
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.
Time frame: 1 year post surgery
GSM Symptoms - 2 years
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.
Time frame: 2 years post surgery
Prolapse Quality of Life - 6 weeks
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.
Time frame: 6 weeks post surgery
Prolapse Quality of Life - 6 months
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.
Time frame: 6 months post surgery
Prolapse Quality of Life - 1 year
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.
Time frame: 1 year post surgery
Prolapse Quality of Life - 2 years
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.
Time frame: 2 years post surgery
Complications - 6 weeks
A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Time frame: 6 weeks post surgery
Complications - 6 months
A composite measure of the incidence of mesh erosion, urinary tract and/or surgical site infections and treatment failure.
Time frame: 6 months post surgery
Treatment Failure - 1 year
A composite measure of the incidence of mesh erosion and treatment failure.
Time frame: 1 year post surgery
Treatment Failure - 2 years
A composite measure of the incidence of mesh erosion and treatment failure.
Time frame: 2 years post surgery
Adherence
Adherence rates during the 6-week intervention period based on groups assignment.
Time frame: 6 weeks post surgery
Plan to share: Yes — The de-identified study data in the REDCap database will be retained on the Queen's CAC system for 15 years after study results are published. After the 15 year data retention period 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.
Supporting information: Study protocol, Informed consent form
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.
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.
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