Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach. Participants will be followed for at least 36-months (3-years) post surgery and up to a maximum of 60-months (5-years) during the primary trial. Participants who complete the primary trial will be approached for consent for long-term follow-up as part of a study extension and will be followed up to a maximum of 120-months (10-years). The investigators hypothesize that treatment failure will not differ between vaginally and abdominally placed mesh for vault vaginal prolapse, and mesh repairs (regardless of route of implantation) will be superior to native tissue apical suspension.

NCT Number	NCT02676973
Lead Sponsor	NICHD Pelvic Floor Disorders Network Collaborators: The Cleveland Clinic, University of Alabama at Birmingham, University of California, San Diego, Duke University, University of New Mexico, Women and Infants Hospital of Rhode Island, RTI International, University of Pennsylvania, University of Pittsburgh, Kaiser Permanente, University of Texas Southwestern Medical Center, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions	Visceral Prolapse
Enrollment	360 participants
Start Date	2016-02-29
Primary Completion	2022-07-28 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-26