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

Running, not enrolling · Not applicable

Conditions studied: Visceral Prolapse

In brief

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.

Key facts

Study ID: NCT02676973
Run by: NICHD Pelvic Floor Disorders Network
People needed: 360
Starts: 2016-02-29
Expected to finish: 2026-12-31
Last updated by the study team: 2025-08-26

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Women age 21 or older
Prior total hysterectomy (no cervix present)
Prolapse beyond the hymen (defined as Ba, C, or Bp > 0 cm)
Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C> -2/3 TVL)
Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
Desires surgical treatment for post-hysterectomy vaginal prolapse
Available for up to 60 month follow-up

You may not qualify if…

Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments
Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse *
Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess
Unresolved chronic pelvic pain-active
Prior abdominal or pelvic radiation
Contraindication to any of the index surgical procedures
Known Horseshoe Kidney or Pelvic Mass overlying the sacrum
Active diverticular abscess or active diverticulitis
Shortened vaginal length (<6 cm TVL)
NOTE:
Only documented SSLS will be an exclusion.
Mesh used for only mid-urethral sling will NOT be an exclusion
If prior POP repair is unknown and unable to be documented, subjects will be eligible based on clinician judgment. The investigator will examine and assess for evidence of mesh or graft if no evidence of mesh or graft is present on examination subject remains eligible.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.