RecruitingNot ApplicableNCT04880239
REDUCE Trial- Reducing Prolapse Recurrence
REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
Sponsor
Northwestern University
Enrollment
200 participants
Start Date
Nov 23, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- 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 Criteria6
- 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
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Interventions
PROCEDUREPosterior colpoperineorrhaphy
Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04880239
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