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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
NCT02676973 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- PROCEDURE Open, Robotic, or Laparoscopic
- PROCEDURE Transvaginal Native Tissue Repair
- PROCEDURE Uphold™ LITE
Study Locations (10)
California
- University of California at San Diego — San Diego
- Kaiser Permanente — San Diego
Pennsylvania
- University of Pennsylvania — Philadelphia
- University of Pittsburgh — Pittsburgh
Alabama
- University of Alabama at Birmingham — Birmingham
New Mexico
- University of New Mexico — Albuquerque
North Carolina
- Duke University — Durham
Ohio
- Cleveland Clinic — Cleveland
Rhode Island
- Brown/Women and Infants Hospital of Rhode Island — Providence
Texas
- University of Texas Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2016-02-29 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02676973
The ClinicalTrials.gov registry entry for NCT02676973 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Pelvic Floor Disorders Network, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Visceral Prolapse appearing as the primary indexed condition, and to 3 interventions — of which Open, Robotic, or Laparoscopic is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02676973 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02676973 about?
NCT02676973 is a clinical study titled "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 pe...
What is the current status of trial NCT02676973?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2016-02-29. Estimated completion is 2026-12-31.
What conditions does trial NCT02676973 study?
This clinical trial studies the following conditions: Visceral Prolapse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02676973?
The interventions under investigation include: Open, Robotic, or Laparoscopic (PROCEDURE), Transvaginal Native Tissue Repair (PROCEDURE), Uphold™ LITE (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02676973?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02676973 being conducted?
This trial has 10 study locations across Alabama, California, New Mexico, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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