A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
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.
⁃ Participants must meet all the following inclusion criteria to be eligible for enrollment into the study:
• 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.