Colpopexy and Urinary Reduction Efforts (CARE) Protocol

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00065845
First received: August 1, 2003
Last updated: January 9, 2011
Last verified: October 2010
  Purpose

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 Intervention Phase
Urinary Incontinence, Stress
Uterine Prolapse
Vaginal Prolapse
Procedure: Burch urethropexy at time of sacrocolpopexy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 322
Study Start Date: April 2002
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065845

Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Iowa
University of Iowa College of Medicine
Iowa City, Iowa, United States, 52242
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7590
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213-3180
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Linda Brubaker, MD Loyola University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Susan Meikle, MD, NICHD
ClinicalTrials.gov Identifier: NCT00065845     History of Changes
Other Study ID Numbers: U01HD41249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041269, U10HD041267
Study First Received: August 1, 2003
Last Updated: January 9, 2011
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Urinary incontinence
Pelvic organ prolapse
Stress incontinence
Sacrocolpopexy
Burch urethropexy
Surgical Trials

Additional relevant MeSH terms:
Prolapse
Urinary Incontinence
Urinary Incontinence, Stress
Uterine Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on April 14, 2014