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NCT01802281 · ClinicalTrials.gov registry record · NA
Study of Uterine Prolapse Procedures - Randomized Trial
A NA study of Uterovaginal Prolapse, sponsored by NICHD Pelvic Floor Disorders Network.
- Completed
- Registry status
- NA
- Development phase
- 183
- Enrollment target
- 8
- Study locations
NCT01802281 is a NA study of Uterovaginal Prolapse that has completed, run by NICHD Pelvic Floor Disorders Network. The registered enrollment target is 183 participants. The trial reports 8 study locations across 7 states.
The verdict
NCT01802281, a NA study of Uterovaginal Prolapse, has completed, sponsored by NICHD Pelvic Floor Disorders Network.
- COMPLETED
- Registry status
- NA
- Development phase
- 183 participants
- Enrollment target
- 8
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. 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 17 total studies on file at ClinicalTrials.gov.
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.
NCT01802281 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Pennsylvania, Alabama, California.
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.
What interventions are being tested in trial NCT01802281?
The interventions under investigation include: Uterosacral ligament suspension (PROCEDURE), Uphold® LITE (PROCEDURE).
Who is sponsoring clinical trial NCT01802281?
This trial is sponsored by NICHD Pelvic Floor Disorders Network, which has 17 total clinical trials registered on ClinicalTrials.gov.
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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