Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT00065845

Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Official Title:

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

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.

Eligibility

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).
3. Inability to provide informed consent or to complete testing or data collection.
4. Currently pregnant.

Disease(s) and\or Condition(s)

Urinary Incontinence, Stress

Uterine Prolapse

Vaginal Prolapse

Primary Purpose
  • PREVENTION
Intervention/Treatment
    • Type: PROCEDURE
    • Name: Burch urethropexy at time of sacrocolpopexy
    • Description: 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).
    • Arm Group Labels: Abdominal Sacral Colpopexy with Burch Colposuspension
Sponsor
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)