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| Sponsored by: |
National Institute of Child Health and Human Development (NICHD) |
| Information provided by: | National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00065845 |
Purpose
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.
| Condition | Intervention |
|
Urinary Incontinence, Stress Uterine Prolapse Vaginal Prolapse |
Procedure: Burch urethropexy at time of sacrocolpopexy |
| MedlinePlus related topics: | Pelvic Support Problems Stress Urinary Incontinence |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts |
| Estimated Enrollment: | 480 |
| Study Start Date: | April 2002 |
| Estimated Study Completion Date: | April 2007 |
Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women.
Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Contacts and Locations| United States, Alabama | |||||
| The University of Alabama at Birmingham | |||||
| Birmingham, Alabama, United States, 35233-7333 | |||||
| United States, Illinois | |||||
| Loyola University Medical Center | |||||
| Maywood, Illinois, United States, 60153 | |||||
| United States, Iowa | |||||
| University of Iowa College of Medicine | |||||
| Iowa City, Iowa, United States, 52242 | |||||
| United States, Maryland | |||||
| Johns Hopkins School of Medicine | |||||
| Baltimore, Maryland, United States, 21287 | |||||
| United States, Michigan | |||||
| University of Michigan | |||||
| Ann Arbor, Michigan, United States, 48109-2029 | |||||
| United States, North Carolina | |||||
| University of North Carolina at Chapel Hill | |||||
| Chapel Hill, North Carolina, United States, 27599-7590 | |||||
| United States, Pennsylvania | |||||
| Magee-Womens Hospital | |||||
| Pittsburgh, Pennsylvania, United States, 15213-3180 | |||||
| United States, Texas | |||||
| Baylor College of Medicine | |||||
| Houston, Texas, United States, 77030 | |||||
| Principal Investigator: | Linda Brubaker, MD | Loyola University |
More Information
| Study ID Numbers: | U01HD41249, U01HD41268, U01HD41248, U01HD41250, U01HD41261, U01HD41263, U01HD41269, U01HD41267 |
| First Received: | August 1, 2003 |
| Last Updated: | April 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00065845 |
| Health Authority: | United States: Federal Government |
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