REDUCE Trial- Reducing Prolapse Recurrence

NCT04880239 | Active Not Recruiting

• 1 other identifier: STU00214588
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prolapse; Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Defecatory Dysfunction

  1 Year

• Dyspareunia

  1 Year

• Surgical and Perioperative Events: Blood Loss

  2 Weeks

• Surgical and Perioperative Events: Operative Time

  Day of surgery

• Surgical and Perioperative Events: Postoperative Pain

  2 Weeks

Study Arms (2)

Sacralcolpopexy with posterior colpoperineorrhaphy

ACTIVE COMPARATOR

Procedure: Posterior colpoperineorrhaphy

Sacralcolpopexy without posterior colpoperineorrhaphy

NO INTERVENTION

Interventions

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

Sacralcolpopexy with posterior colpoperineorrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• University of Kansas: collaborator
• The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julia Geynisman-Tan, M.D

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research; Assistant Professor

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 10, 2021
• Study Start: November 23, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)