Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Completed
CT.gov ID
NCT00065845
Collaborator
(none)
322
7
2
60
46
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Burch urethropexy at time of sacrocolpopexy
Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
322 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Mar 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Abdominal Sacral Colpopexy with no Burch colposuspension

Abdominal sacral colpopexy is performed through a laparotomy approach.

Experimental: Abdominal Sacral Colpopexy with Burch Colposuspension

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).

Procedure: Burch urethropexy at time of sacrocolpopexy
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).

Outcome Measures

Primary Outcome Measures

  1. Stress urinary continence [3 months]

    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).

Secondary Outcome Measures

  1. Complications at surgery [2 years]

    Complications at surgery

  2. Occurrence of other lower urinary tract symptoms [3 mo, 2 years]

    measured by the urgency and obstructed voiding subscales of the PFDI

  3. Other pelvic symptoms and health-related quality of life [3 mo, 2 years]

    includes bowel function and sexual function

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

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.

  1. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).

  2. Inability to provide informed consent or to complete testing or data collection.

  3. Currently pregnant.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Alabama at Birmingham Birmingham Alabama United States 35233-7333
2 Loyola University Medical Center Maywood Illinois United States 60153
3 University of Iowa College of Medicine Iowa City Iowa United States 52242
4 Johns Hopkins School of Medicine Baltimore Maryland United States 21287
5 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599-7590
6 Magee-Womens Hospital Pittsburgh Pennsylvania United States 15213-3180
7 Baylor College of Medicine Houston Texas United States 77030

Sponsors and Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Linda Brubaker, MD, Loyola University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00065845
Other Study ID Numbers:
  • U01HD041249
  • U10HD041268
  • U10HD041248
  • U10HD041250
  • U10HD041261
  • U10HD041263
  • U10HD041269
  • U10HD041267
First Posted:
Aug 5, 2003
Last Update Posted:
Jan 11, 2011
Last Verified:
Oct 1, 2010

Study Results

No Results Posted as of Jan 11, 2011