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Home > "P" Clinical Trials Conditions > Pelvic Floor Disorders Network  Pelvic Floor Disorders Network
Pelvic Floor Disorders Network
For Condition: Urinary Incontinence, Stress,Vaginal Prolapse,Uterine Prolapse
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Single Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: Inclusion Criteria - Stage II-IV anterior vaginal prolapse - Negative stress incontinence screen (MESA questionnaire)
Total Enrollment: 480
Location and Contact Information:
Overall Study Official:
LindaBrubaker, , Loyola University
University of Iowa College of Medicine *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting Debra Brandt 319-384-8743
The University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35233-7333
United States
Recruiting Velria Willis 205-975-8522
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Stacy Tegeler 713-798-7514
University of Michigan
Ann Arbor, Michigan, 48109-2029
United States
Margaret Steiner 734-615-9051
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Judy Gruss 412-641-5388
University of North Carolina at Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7590
United States
Recruiting Anita Murphy 919-966-4717
Johns Hopkins School of Medicine *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Betty Sauter 410-614-4495
Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting Dorothea Koch 708-216-4188
Additional Information:
Study ID Numbers: U01HD41249; U01HD41267,U01HD41248,U01HD41269,U01HD41268,U01HD41261,U01HD41250,U01HD41263
Study Start Date: April 2002
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065845
Other Urinary Incontinence, Stress Studies:
1. Pelvic Floor Disorders Network
Related Studies:
Other Urinary Incontinence, Stress Clinical Trials
Other Iowa Clinical Trials
Other Iowa City Clinical Trials
Pelvic Floor Disorders Network
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