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REDUCE Trial- Reducing Prolapse Recurrence

NCT04880239 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-04-23

No results posted yet for this study

Summary

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

Conditions

  • Prolapse; Female

Interventions

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

Sponsors & Collaborators

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

    collaborator OTHER

  • University of Kansas

    collaborator OTHER

  • Northwestern University

    lead OTHER

Principal Investigators

  • Julia Geynisman-Tan, M.D · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2026-10-01
Completion
2026-12-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880239 on ClinicalTrials.gov