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ACTIVE NOT RECRUITING
NCT02676973
NA

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

Sponsor: NICHD Pelvic Floor Disorders Network

View on ClinicalTrials.gov

Summary

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.

Official title: Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial Involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2016-02-29

Completion Date

2026-12-31

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

PROCEDURE

Open, Robotic, or Laparoscopic

Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.

PROCEDURE

Transvaginal Native Tissue Repair

Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).

PROCEDURE

Uphold™ LITE

Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.

Locations (10)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California at San Diego

San Diego, California, United States

Kaiser Permanente

San Diego, California, United States

University of New Mexico

Albuquerque, New Mexico, United States

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Brown/Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States