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Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence (SISTEr)

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ClinicalTrials.gov Identifier: NCT00064662
Recruitment Status : Completed
First Posted : July 11, 2003
Results First Posted : September 28, 2012
Last Update Posted : May 10, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Procedure: Burch Modified Tanagho Procedure: Autologous Fascia Sling Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 655 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Study Start Date : February 2002
Primary Completion Date : June 2006
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Burch
The Burch colposuspension
Procedure: Burch Modified Tanagho
The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.
Sling
Pubovaginal sling, using autologous rectus fascia
Procedure: Autologous Fascia Sling
The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures


Outcome Measures

Primary Outcome Measures :
  1. 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). [ Time Frame: 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.

  2. 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success) [ Time Frame: 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.


Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • Predominant stress urinary incontinence by self-report,examination and test;
  • Urethral hypermobility;
  • Eligible for both surgical procedures;
  • Ambulatory;
  • Not pregnant;
  • >12 months post-partum;
  • No systemic disease known to affect bladder function;
  • No current chemotherapy or radiation therapy;
  • No urethral diverticulum, augmentation cytoplasty, or artificial sphincter;
  • No recent pelvic surgery;
  • Available for follow-up and able to complete study assessments;
  • Signed informed consent.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00064662


Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249-7333
United States, California
University of California
San Diego, California, United States, 92037
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas, Southwestern
Dallas, Texas, United States, 75390-9110
University of Texas Health Sciences Center
San Antonio, Texas, United States, 78229-3900
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
New England Research Institutes
University of Alabama at Birmingham
University of California, San Diego
University of Maryland
University of Pittsburgh
University of Texas
The University of Texas at San Antonio
University of Utah
Beaumont Hospital
Loyola University
Investigators
Study Chair: William D. Steers, M.D. University of Virginia
More Information

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00064662     History of Changes
Other Study ID Numbers: UITN-RCT (completed)
First Posted: July 11, 2003    Key Record Dates
Results First Posted: September 28, 2012
Last Update Posted: May 10, 2013
Last Verified: May 2013

Keywords provided by New England Research Institutes:
Stress urinary incontinence
Surgery

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders