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

Further Study Details: 

Expected Total Enrollment:  480

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.

Genders Eligible for Study:  Female

Criteria

Inclusion Criteria

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

Anne Weber, MD      301-435-6972    webera@mail.nih.gov

Alabama
      The University of Alabama at Birmingham, Birmingham,  Alabama,  35233-7333,  United States; Recruiting
Illinois
      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
Iowa
      University of Iowa College of Medicine, Iowa City,  Iowa,  52242,  United States; Recruiting
Maryland
      Johns Hopkins School of Medicine, Baltimore,  Maryland,  21287,  United States; Recruiting
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109-2029,  United States; No longer recruiting
North Carolina
      University of North Carolina at Chapel Hill, Chapel Hill,  North Carolina,  27599-7590,  United States; Recruiting
Pennsylvania
      Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting

Study chairs or principal investigators

Linda Brubaker, MD,  Loyola University   

Study ID Numbers:  U01HD41249; U01HD41268; U01HD41248; U01HD41250; U01HD41261; U01HD41263; U01HD41269; U01HD41267
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  August 1, 2003
ClinicalTrials.gov Identifier:  NCT00065845
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08