Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

Phase 2

Completed

• Conditions: Urinary Incontinence
• Interventions: Procedure: Burch Modified Tanagho; Procedure: Autologous Fascia Sling

• Registration Number: NCT00064662
• Lead Sponsor: Carelon Research

Brief Summary

The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2003-07-10
• Study First Submitted QC: 2003-07-10
• Study First Posted: 2003-07-11
• Primary Completion: 2006-06
• Study Completion: 2010-03
• Results First Submitted: 2012-03-26
• Results First Submitted QC: 2012-08-27
• Results First Posted: 2012-09-28
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 655

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Burch	Burch Modified Tanagho	The Burch colposuspension
Sling	Autologous Fascia Sling	Pubovaginal sling, using autologous rectus fascia

Primary Outcome Measures

Name	Time	Method
24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).	Two years	Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.
24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)	Two years	Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.

Trial Locations

Locations (9)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

University of Texas, Southwestern; 🇺🇸 Dallas, Texas, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

University of California; 🇺🇸 San Diego, California, United States

University of Texas Health Sciences Center; 🇺🇸 San Antonio, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States