REDUCE Trial- Reducing Prolapse Recurrence

Northwestern University

Status: Enrolling

Conditions: Prolapse; Female

Treatments: Procedure: Posterior colpoperineorrhaphy

Study type: Interventional

Funder types: Other

Identifiers

NCT04880239

STU00214588

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Sacralcolpopexy with posterior colpoperineorrhaphy

Active Comparator group

Treatment:

Procedure: Posterior colpoperineorrhaphy

Sacralcolpopexy without posterior colpoperineorrhaphy

No Intervention group