Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorQueen's University

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

Qualifiers

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

Treatments tested in this trial

  • Vaginal Estrogen - Twice Weekly
  • Vaginal Estrogen - Daily

Treatment groups

180 Participants
are divided into 3 treatment groups

Sponsors and collaborators