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Study of Uterine Prolapse Procedures - Randomized Trial
NCT01802281 · View on ClinicalTrials.gov ↗
Study Summary
The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years. A supplemental study investigates anterior vaginal wall movement resulting from descent or rotation of the vaginal apex and/or anterior vaginal elongation, in women in both of the study arms of SUPeR.
Conditions Studied
Interventions
- PROCEDURE Uterosacral ligament suspension
- PROCEDURE Uphold® LITE
Study Locations (8)
Pennsylvania
- University of Pennsylvania — Philadelphia
- Magee-Women's Hospital, Department of Obstetrics and Gynecology — Pittsburgh
Alabama
- University of Alabama at Birmingham, Department of Obstetrics and Gynecology — Birmingham
California
- University of California at San Diego, UCSD Women's Pelvic Medicine Center — La Jolla
New Mexico
- University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology — Albuquerque
North Carolina
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham
Ohio
- Cleveland Clinic, Department OB/GYN — Cleveland
Rhode Island
- Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2013-04-01 |
| Est. Completion | 2025-03-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01802281
The ClinicalTrials.gov registry entry for NCT01802281 describes a study currently listed as completed. 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 183 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 Uterovaginal Prolapse appearing as the primary indexed condition, and to 2 interventions — of which Uterosacral ligament suspension 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: NCT01802281 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Pennsylvania, Alabama, California. 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 NCT01802281 about?
NCT01802281 is a clinical study titled "Study of Uterine Prolapse Procedures - Randomized Trial". The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to dete...
What is the current status of trial NCT01802281?
This trial is currently completed. It is a NA study. The enrollment target is 183 participants. The study started on 2013-04-01. Estimated completion is 2025-03-07.
What conditions does trial NCT01802281 study?
This clinical trial studies the following conditions: Uterovaginal 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 NCT01802281?
The interventions under investigation include: Uterosacral ligament suspension (PROCEDURE), Uphold® LITE (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01802281?
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 NCT01802281 being conducted?
This trial has 8 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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