Colpopexy and Urinary Reduction Efforts (CARE) Protocol
- Conditions
- Urinary Incontinence, StressUterine ProlapseVaginal Prolapse
- Interventions
- Procedure: Burch urethropexy at time of sacrocolpopexy
- Registration Number
- NCT00065845
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 322
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abdominal Sacral Colpopexy with Burch Colposuspension Burch urethropexy at time of sacrocolpopexy The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).
- Primary Outcome Measures
Name Time Method Stress urinary continence 3 months 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).
- Secondary Outcome Measures
Name Time Method Complications at surgery 2 years Complications at surgery
Occurrence of other lower urinary tract symptoms 3 mo, 2 years measured by the urgency and obstructed voiding subscales of the PFDI
Other pelvic symptoms and health-related quality of life 3 mo, 2 years includes bowel function and sexual function
Trial Locations
- Locations (7)
University of Iowa College of Medicine
🇺🇸Iowa City, Iowa, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States