Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
ConditionPelvic Organ Prolapse (POP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSarah Wozney
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Vaginal Estrogen - Twice Weekly
DrugTwice weekly for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime .
Vaginal Estrogen - Daily
DrugDaily for six weeks following pelvic organ prolapse repair surgery. 0.5 grams of cream per vagina at bedtime.
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: No Vaginal Estrogen GroupNo intervention 0 interventions
Group B: Twice Weekly Vaginal Estrogen GroupActive comparator 1 intervention
Group C: Daily Vaginal Estrogen GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgeryOther outcomes
1
Adherence
Adherence rates during the 6-week intervention period based on groups assignment.
Time frame
6 weeks post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Sarah Wozney
Lead sponsor
Queen's University
Sponsor institution
Source ClinicalTrials.gov