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Active (not recruiting) Not applicable NCT04880239

REDUCE Trial- Reducing Prolapse Recurrence

No applicable phase (e.g. observational)
Conditions: Prolapse; Female

Sponsor: Northwestern University

trial.available_in: БГ
Overview
This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.
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 posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.
Who can participate
Inclusion Criteria: * 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 Criteria: * 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
Interventions
Posterior colpoperineorrhaphy
PROCEDURE
Locations 1
United States (1)
Northwestern University
Chicago , Illinois
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
23.11.2021
Completion date
30.12.2026
Registry ID
NCT04880239
Source
clinicaltrials.gov
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