Image

REDUCE Trial- Reducing Prolapse Recurrence

REDUCE Trial- Reducing Prolapse Recurrence

Not Recruiting
18 years and older
Female
Phase N/A

Powered by AI

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.

Eligibility

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

Study details
    Prolapse; Female

NCT04880239

Northwestern University

13 May 2026

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.