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NCT00271037 · ClinicalTrials.gov registry record
Colpocleisis for Advanced Pelvic Organ Prolapse
A clinical trial of Pelvic Organ Prolapse and Stress Urinary Incontinence, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- 152
- Enrollment target
- 6
- Study locations
NCT00271037 is a study of Pelvic Organ Prolapse and Stress Urinary Incontinence that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 152 participants, roughly in line with the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target. The trial reports 6 study locations across 6 states.
The verdict
NCT00271037, a study of Pelvic Organ Prolapse and Stress Urinary Incontinence, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- 152 participants
- Enrollment target
- 6
- Study locations
Study Summary
Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery repairs the prolapse by essentially closing the vagina (e.g., colpocleisis or colpectomy), thereby leaving a woman unable to have vaginal intercourse in the future. The use of colpocleisis has not been well-studied. The current literature is lacking sufficient studies of colpocleisis to fully understand its risks and benefits for women considering surgery for prolapse. Traditionally, colpocleisis has been restricted to elderly women thought to be poor medical risks for prolonged reconstructive surgery. This study will describe the postoperative course of women who undergo colpocleisis, with particular attention to the persistence or recurrence of urinary incontinence and patient satisfaction after the colpocleisis prolapse surgery.
Conditions Studied
Interventions
- PROCEDURE Colpocleisis prolapse repair surgery
- PROCEDURE sling or other to treat or prevent stress incontinence
Study Locations (6)
Alabama
- University of Alabama - Birmingham
Illinois
- Loyola University - Maywood
Iowa
- University of Iowa - Iowa City
Maryland
- Johns Hopkins University - Baltimore
North Carolina
- University of North Carolina - Chapel Hill
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-04 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00271037
The ClinicalTrials.gov registry entry for NCT00271037 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 141-participant average among 40 other Pelvic Organ Prolapse trials with a reported enrollment target. The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pelvic Organ Prolapse appearing as the primary indexed condition, and to 2 interventions - of which Colpocleisis prolapse repair surgery is the first listed.
NCT00271037 reports 6 study locations spanning 6 distinct geographic areas - top geographies include Alabama, Illinois, Iowa.
Frequently Asked Questions
What is clinical trial NCT00271037 about?
NCT00271037 is a clinical study titled "Colpocleisis for Advanced Pelvic Organ Prolapse". Pelvic organ prolapse occurs when the pelvic organs (e.g., the uterus or bladder) fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. Some types of surgery try to restore the normal anatomy and function of the vagina (i.e., reconstructive surgery). Other surgery ...
What is the current status of trial NCT00271037?
This trial is currently completed. The enrollment target is 152 participants. The study started on 2004-07. Estimated completion is 2007-04.
What conditions does trial NCT00271037 study?
This clinical trial studies the following conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence.
What interventions are being tested in trial NCT00271037?
The interventions under investigation include: Colpocleisis prolapse repair surgery (PROCEDURE), sling or other to treat or prevent stress incontinence (PROCEDURE).
Who is sponsoring clinical trial NCT00271037?
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 NCT00271037 being conducted?
This trial has 6 study locations across Alabama, Illinois, Iowa, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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