REDUCE Trial- Reducing Prolapse Recurrence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2026-07-30

Brief Summary

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This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.

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Detailed Description

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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.

Conditions

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Prolapse; Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sacralcolpopexy with posterior colpoperineorrhaphy

Group Type ACTIVE_COMPARATOR

Posterior colpoperineorrhaphy

Intervention Type PROCEDURE

Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy

Sacralcolpopexy without posterior colpoperineorrhaphy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Posterior 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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No