Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04880239

REDUCE Trial- Reducing Prolapse Recurrence

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Posterior colpoperineorrhaphy

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

Primary outcomes

  1. Pelvic Organ Prolapse Quantification (POP-Q) System

    Time frame: 1 Year

    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.

Secondary outcomes

  1. Defecatory Dysfunction

    Time frame: 1 Year

    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).

  2. Dyspareunia

    Time frame: 1 Year

    To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)

  3. Surgical and Perioperative Events: Blood Loss

    Time frame: 2 Weeks

    To compare the estimated blood loss (in milliliters) between groups.

  4. Surgical and Perioperative Events: Operative Time

    Time frame: Day of surgery

    To compare the operative time (in minutes as listed on the surgical case tracking) between groups.

  5. Surgical and Perioperative Events: Postoperative Pain

    Time frame: 2 Weeks

    To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.

  6. Surgical and Perioperative Events: Pain Medication Use

    Time frame: 2 Weeks

    To compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
  • University of Kansas

Registry information

Official study title

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 10, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.