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NCT00065845 · ClinicalTrials.gov registry record · Phase 3
Colpopexy and Urinary Reduction Efforts (CARE) Protocol
A Phase 3 study of Urinary Incontinence,Stress and Uterine Prolapse, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
- 7
- Study locations
NCT00065845: Completed Phase 3 study of Urinary Incontinence,Stress and Uterine Prolapse, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT00065845 is a Phase 3 study of Urinary Incontinence,Stress and Uterine Prolapse that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 322 participants, above the 289-participant average among 5 other Urinary Incontinence,Stress trials with a reported enrollment target (11% higher). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00065845, a Phase 3 study of Urinary Incontinence,Stress and Uterine Prolapse, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
- 7
- Study locations
Study Summary
Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.
Primary Outcome
Patients will be categorized as stress continent or stress incontinent on the basis of symptom assessment and stress testing. The symptoms will be assessed by the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI).
Conditions Studied
Interventions
- PROCEDURE Burch urethropexy at time of sacrocolpopexy
Study Locations (7)
Alabama
- The University of Alabama at Birmingham - Birmingham
Illinois
- Loyola University Medical Center - Maywood
Iowa
- University of Iowa College of Medicine - Iowa City
Maryland
- Johns Hopkins School of Medicine - Baltimore
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Pennsylvania
- Magee-Womens Hospital - Pittsburgh
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2002-04 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the finished NCT00065845 record still lists
NCT00065845 is an interventional study that assigns participants to a tested intervention. The registered 322 participants enrollment target is mid-sized for trials with a published cap, above the 289-participant average among 5 other Urinary Incontinence,Stress trials with a reported enrollment target (11% higher).
The record links to 3 conditions, with Urinary Incontinence,Stress appearing as the primary indexed condition, and to 1 intervention - of which Burch urethropexy at time of sacrocolpopexy is the first listed.
NCT00065845 lists 7 locations in 7 states (Alabama, Illinois, Iowa).
Frequently Asked Questions
What is clinical trial NCT00065845 about?
NCT00065845 is a clinical study titled "Colpopexy and Urinary Reduction Efforts (CARE) Protocol". Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will dete...
What is the current status of trial NCT00065845?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2002-04. Estimated completion is 2007-04.
What conditions does trial NCT00065845 study?
This clinical trial studies the following conditions: Urinary Incontinence,Stress, Uterine Prolapse, Vaginal Prolapse.
What interventions are being tested in trial NCT00065845?
The interventions under investigation include: Burch urethropexy at time of sacrocolpopexy (PROCEDURE).
Who is sponsoring clinical trial NCT00065845?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00065845 being conducted?
This trial has 7 study locations across Alabama, Illinois, Iowa, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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