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REDUCE Trial- Reducing Prolapse Recurrence

REDUCE Trial - Reducing Prolapse Recurrence by Reducing the Genital Hiatus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04880239
Enrollment
200
Registered
2021-05-10
Start date
2021-11-23
Completion date
2026-12-30
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolapse; Female

Brief summary

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

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.

Interventions

PROCEDUREPosterior 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

Sponsors

Northwestern University
Lead SponsorOTHER
The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
CollaboratorOTHER
University of Kansas
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pelvic Organ Prolapse Quantification (POP-Q) System1 YearThe 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

MeasureTime frameDescription
Defecatory Dysfunction1 YearTo 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).
Dyspareunia1 YearTo compare the rates of dyspareunia between groups using the Female Sexual Function Index (measured from 2-36 points)
Surgical and Perioperative Events: Blood Loss2 WeeksTo compare the estimated blood loss (in milliliters) between groups.
Surgical and Perioperative Events: Operative TimeDay of surgeryTo compare the operative time (in minutes as listed on the surgical case tracking) between groups.
Surgical and Perioperative Events: Postoperative Pain2 WeeksTo compare postoperative pain scores using a visual analog scale (0-100 points) between groups.
Surgical and Perioperative Events: Pain Medication Use2 WeeksTo compare narcotic pain medication use (in morphine equivalents consumed and reported by patients) between groups.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJulia Geynisman-Tan, M.D

Northwestern University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026