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

NCT02676973 · tracked via the Priya Life Science Mexico tracker

Sponsor

NICHD Pelvic Floor Disorders Network

Phase

Not applicable

Started

2016-02-29

Last updated

2026-09-15

Condition(s) studied

Visceral Prolapse

Investigational drug(s) / intervention(s)

Open, Robotic, or LaparoscopicTransvaginal Native Tissue RepairUphold™ LITE

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.

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).

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.

Study 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.

Eligibility

Sex

FEMALE

Min age

21 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Women age 21 or older 2. Prior total hysterectomy (no cervix present) 3. Prolapse beyond the hymen (defined as Ba, C, or Bp \> 0 cm) 4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C\> -2/3 TVL) 5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out' 6. Desires surgical treatment for post-hysterectomy vaginal prolapse 7. Available for up to 60 month follow-up Exclusion Criteria: 1. Previous synthetic material or biologic grafts (placed vaginally or abdominally) to augment POP repair including anterior, posterior and/or apical compartments 2. Known previous formal SSLS performed for either uterovaginal or post-hysterectomy vaginal vault prolapse \* 3. Known adverse reaction to synthetic mesh or biological grafts; these complications include but are not limited to erosion, fistula, or abscess 4. Unresolved chronic pelvic pain-active 5. Prior abdominal or pelvic radiation 6. 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.

Primary outcome measure(s)

Number of Participants Considered Failures — 6 months through 60 Months
Failure was defined as any of the following: retreatment for prolapse, any POP-Q measure beyond the hymen, or presence of bother on PFDI vaginal bulge question. Under the permanent failure state assumption, the number of participants shown at each visit includes all participants who were still participating in the study or had a failure outcome prior their withdrawal. Similarly, the denominator number of participants for the cumulative failure at each visit includes all participants who were still participating in the study and attended the visit or had any failure outcome prior their withdrawal or missed visit.

Trial sites (10)

Facility	City	Region
University of Alabama at Birmingham	Birmingham	Alabama
University of California at San Diego	San Diego	California
Kaiser Permanente	San Diego	California
University of New Mexico	Albuquerque	New Mexico
Duke University	Durham	North Carolina
Cleveland Clinic	Cleveland	Ohio
University of Pennsylvania	Philadelphia	Pennsylvania
University of Pittsburgh	Pittsburgh	Pennsylvania
Brown/Women and Infants Hospital of Rhode Island	Providence	Rhode Island
University of Texas Southwestern Medical Center	Dallas	Texas

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02676973 on ClinicalTrials.gov ↗ ← All trials in Mexico