Colpopexy and Urinary Reduction Efforts (CARE) Protocol

• Stress urinary continence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  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).
  
  

• Complications at surgery [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  Complications at surgery
  
  
• Occurrence of other lower urinary tract symptoms [ Time Frame: 3 mo, 2 years ] [ Designated as safety issue: No ]
  measured by the urgency and obstructed voiding subscales of the PFDI
  
  
• Other pelvic symptoms and health-related quality of life [ Time Frame: 3 mo, 2 years ] [ Designated as safety issue: No ]
  includes bowel function and sexual function
  
  

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.