Colpopexy and Urinary Reduction Efforts (CARE) Protocol - Tabular View

Tracking Information

First Received Date ^ICMJE

August 1, 2003

Last Updated Date

April 6, 2007

Start Date ^ICMJE

April 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00065845 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Official Title ^ICMJE

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

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.

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Urinary Incontinence, Stress
Uterine Prolapse
Vaginal Prolapse

Intervention ^ICMJE

Procedure: Burch urethropexy at time of sacrocolpopexy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

480

Estimated Completion Date

April 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria

Stage II-IV anterior vaginal prolapse
Negative stress incontinence screen (MESA questionnaire)

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00065845

Responsible Party

Study ID Numbers ^ICMJE

U01HD41249, U01HD41268, U01HD41248, U01HD41250, U01HD41261, U01HD41263, U01HD41269, U01HD41267

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Linda Brubaker, MD

Loyola University

Information Provided By

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

Verification Date

April 2007

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