NCT00065845

Colpopexy and Urinary Reduction Efforts (CARE) Protocol

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 322 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Incontinence, Stress
• Uterine Prolapse
• Vaginal Prolapse

Interventions

Type	Name	Description
PROCEDURE	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).

Timeline

• Start date: 2002-04-01
• Primary completion: 2007-03-01
• Completion: 2007-04-01
• First posted: 2003-08-05
• Last updated: 2011-01-11

Locations

7 sites across 1 country: United States