REDUCE Trial- Reducing Prolapse Recurrence

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

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

Study Overview

• Status: Active, not recruiting
• Conditions: Prolapse; Female
• Intervention / Treatment: Procedure: Posterior colpoperineorrhaphy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sacralcolpopexy with posterior colpoperineorrhaphy	Procedure: 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
No Intervention: Sacralcolpopexy without posterior colpoperineorrhaphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pelvic Organ Prolapse Quantification (POP-Q) System	The POP-Q System will be used to compare the rate of prolapse recurrence at 1 year between women undergoing a sacrocolpopexy with Restorelle mesh with and without a concomitant posterior colpoperineorrhaphy.	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defecatory Dysfunction	To compare the rates of defecatory dysfunction using the Bristol Stool Scale (stool types measured from type 1-type 7) and the Colorectal-Anal Distress Inventory 8 (measured from 0-100 points).	1 Year
Dyspareunia	To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)	1 Year
Surgical and Perioperative Events: Blood Loss	To compare the estimated blood loss (in milliliters) between groups.	2 Weeks
Surgical and Perioperative Events: Operative Time	To compare the operative time (in minutes as listed on the surgical case tracking) between groups.	Day of surgery
Surgical and Perioperative Events: Postoperative Pain	To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.	2 Weeks
Surgical and Perioperative Events: Pain Medication Use	To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.	2 Weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania; University of Kansas
• Investigators: Principal Investigator: Julia Geynisman-Tan, M.D, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prolapse
• Other Study ID Numbers: STU00214588

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No