Colpopexy and Urinary Reduction Efforts (CARE) Protocol

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.

Inclusion criteria

• Eligibility for primary procedure (sacrocolpopexy)
• Eligibility for secondary procedure (Burch colposuspension)
• Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.
• Negative stress incontinence screen
• Negative stress incontinence screen (MESA questionnaire)

Exclusion criteria

• Contraindication for sacrocolpopexy or Burch colposuspension.

• Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm).
• Surgeon judgment that a contraindication to Burch colposuspension exists.
• Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
• Inability to provide informed consent or to complete testing or data collection.
• Currently pregnant.