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| 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 | Phase |
|---|---|---|
|
Urinary Incontinence, Stress Uterine Prolapse Vaginal Prolapse |
Procedure: Burch urethropexy at time of sacrocolpopexy |
Phase III |
| 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 |
| 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.
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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).
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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).
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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 |
Inclusion Criteria
Exclusion Criteria
Contraindication for sacrocolpopexy or Burch colposuspension.
Contacts and 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 | |
| Principal Investigator: | Linda Brubaker, MD | Loyola University |
More Information
| 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 |
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Urinary incontinence Pelvic organ prolapse Stress incontinence |
Sacrocolpopexy Burch urethropexy Surgical Trials |
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Urinary Incontinence Prolapse Urinary Incontinence, Stress Uterine Prolapse Urination Disorders Urologic Diseases |
Urological Manifestations Signs and Symptoms Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female Pelvic Organ Prolapse |