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

August 1, 2003
January 9, 2011
April 2002
March 2007   (final data collection date for primary outcome measure)
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).
Not Provided
Complete list of historical versions of study NCT00065845 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Colpopexy and Urinary Reduction Efforts (CARE) Protocol
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Urinary Incontinence, Stress
  • Uterine Prolapse
  • Vaginal Prolapse
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).
  • 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).
    Intervention: Procedure: Burch urethropexy at time of sacrocolpopexy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
April 2007
March 2007   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065845
U01HD41249, U10HD041268, U10HD041248, U10HD041250, U10HD041261, U10HD041263, U10HD041269, U10HD041267
Yes
Susan Meikle, MD, NICHD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Linda Brubaker, MD Loyola University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP