Status:
RECRUITING
REDUCE Trial- Reducing Prolapse Recurrence
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
University of Kansas
Conditions:
Prolapse; Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
Detailed Description
The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating ...
Eligibility Criteria
Inclusion
- Women over the age of 18
- English or Spanish speaking
- Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
- Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm
Exclusion
- Patient has had prior prolapse surgery
- Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
- Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no)
- Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam
- Patient planning a concomitant Burch procedure
- Pregnant
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04880239
Start Date
November 23 2021
End Date
July 30 2026
Last Update
April 27 2025
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611