CARE
Colpopexy and Urinary Reduction Efforts
Public Access Data and FormsThe Colpopexy and Urinary Reduction Efforts (CARE) study was designed to assess whether the addition of standardized Burch colposuspension to abdominal sacrocolpopexy for the treatment of pelvic-organ prolapse decreases postoperative stress urinary incontinence (SUI) in women without preoperative symptoms of stress incontinence. Women who did not report symptoms of stress incontinence and who chose to undergo sacrocolpopexy to treat prolapse were randomly assigned to concomitant Burch colposuspension or to no Burch colposuspension (control) and were evaluated in a blinded fashion three months after the surgery.
The surgical team was masked to a standardized pre-operative multi-channel urodynamic assessment, including prolapse reduction. The primary outcome at 3 months after surgery was SUI, defined as positive stress test at 300 cc bladder volume OR affirmative answers to any of the Pelvic Floor Distress Inventory (PFDI) stress incontinence subscale questions OR treatment (or re-treatment) for SUI. Due to concern that other urinary symptoms may be worsened by addition of the Burch, a parallel urge endpoint was defined as a positive response to any PFDI urgency and obstructed voiding subscale questions OR treatment for urge incontinence. Evaluators and subjects were also masked to treatment assignment.
In this study of 322 women (157 Burch colposuspension and 165 controls), 3 months after surgery, 33.6 percent of the women in the Burch group and 57.4 percent of the controls met one or more of the criteria for stress incontinence.
STUDY RESULTS SUMMARY
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