Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Public ClinicalTrials.gov record NCT02676973. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02676973
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 360 participants
Conditions and interventions
Conditions
Interventions
- Open, Robotic, or Laparoscopic Procedure
- Transvaginal Native Tissue Repair Procedure
- Uphold™ LITE Procedure
Procedure
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2016 (Actual)
- Primary completion
- Jul 28, 2022 (Actual)
- Completion
- Dec 31, 2026 (Estimated)
- Last update posted
- Sep 15, 2026
2016 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| University of California at San Diego | San Diego | California | 92037 | — |
| Kaiser Permanente | San Diego | California | 92110 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Duke University | Durham | North Carolina | 27707 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19118 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Brown/Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02903 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02676973, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 15, 2026 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02676973 live on ClinicalTrials.gov.