REDUCE Trial- Reducing Prolapse Recurrence

Prolapse; Female Clinical Trial

Official title:

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04880239
• Other study ID #: STU00214588
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: July 30, 2026

Study information

• Verified date: March 2024
• Source: Northwestern University
• Contact: Julia Geynisman-Tan, MD
• Phone: 16302478274
• Email: julia.geynisman-tan[@]nm.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 30, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Prolapse
• Prolapse; Female
• Recurrence

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Dyspareunia	To compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)	1 Year
Secondary	Surgical and Perioperative Events: Blood Loss	To compare the estimated blood loss (in milliliters) between groups.	2 Weeks
Secondary	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
Secondary	Surgical and Perioperative Events: Postoperative Pain	To compare postoperative pain scores using a visual analog scale (0-100 points) between groups.	2 Weeks
Secondary	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