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Colpopexy and Urinary Reduction Efforts (CARE) Protocol
This study is ongoing, but not recruiting participants.
First Received: August 1, 2003   Last Updated: April 6, 2007   History of Changes
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00065845
  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
Urinary Incontinence, Stress
Uterine Prolapse
Vaginal Prolapse
Procedure: Burch urethropexy at time of sacrocolpopexy

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
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):

Estimated Enrollment: 480
Study Start Date: April 2002
Estimated Study Completion Date: April 2007
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

  • Stage II-IV anterior vaginal prolapse
  • Negative stress incontinence screen (MESA questionnaire)
  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, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-2029
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

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: U01HD41249, U01HD41268, U01HD41248, U01HD41250, U01HD41261, U01HD41263, U01HD41269, U01HD41267
Study First Received: August 1, 2003
Last Updated: April 6, 2007
ClinicalTrials.gov Identifier: NCT00065845     History of Changes
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:
Pathological Conditions, Anatomical
Gastrointestinal Diseases
Uterine Prolapse
Urination Disorders
Uterine Diseases
Intestinal Diseases
Prolapse
Rectal Diseases
Genital Diseases, Female
Urological Manifestations
Signs and Symptoms
Digestive System Diseases
Urinary Incontinence, Stress
Urologic Diseases
Urinary Incontinence
Rectal Prolapse

ClinicalTrials.gov processed this record on November 09, 2009