Colpopexy and Urinary Reduction Efforts (CARE) Protocol

United States Department of Health and Human Services (HHS)

Status and phase: Completed; Phase 3

Conditions: Urinary Incontinence, Stress; Uterine Prolapse; Vaginal Prolapse

Treatments: Procedure: Burch urethropexy at time of sacrocolpopexy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00065845

U10HD041261 (U.S. NIH Grant/Contract)

U10HD041268 (U.S. NIH Grant/Contract)

U10HD041248 (U.S. NIH Grant/Contract)

U10HD041263 (U.S. NIH Grant/Contract)

U10HD041267 (U.S. NIH Grant/Contract)

U10HD041269 (U.S. NIH Grant/Contract)

U01HD041249

U10HD041250 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 322 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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322 participants in 2 patient groups

Abdominal Sacral Colpopexy with no Burch colposuspension

No Intervention group

Description:

Abdominal sacral colpopexy is performed through a laparotomy approach.

Abdominal Sacral Colpopexy with Burch Colposuspension

Experimental group

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).

Treatment:

Procedure: Burch urethropexy at time of sacrocolpopexy