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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: Completed NA study of Uterovaginal Prolapse, sponsored by NICHD Pelvic Floor Disorders Network.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 sti
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 |
What the finished NCT01802281 record still lists
NCT01802281 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
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 lists 8 locations in 7 states (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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Where NCT01802281's enrollment target sits among peer trials
183 584th of 2000 higher than 1,417 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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