Recruiting

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

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What is being tested

Posterior colpoperineorrhaphy

Procedure
Who is being recruted

Prolapse

+ Pathological Conditions, Signs and Symptoms

+ Pathological Conditions, Anatomical

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2021
See protocol details

Summary

Principal SponsorNorthwestern University
Study ContactJulia Geynisman-Tan, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 23, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleREDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus
NCT04880239
Principal SponsorNorthwestern University
Study ContactJulia Geynisman-Tan, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ProlapsePathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Criteria

4 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Northwestern University

Chicago, United StatesOpen Northwestern University in Google Maps
Recruiting
One Study Center