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

This study has been completed.
Sponsor:
Collaborators:
University of Alabama at Birmingham
University of California, San Diego
University of Maryland
University of Pittsburgh
University of Texas
University of Texas-SanAntonio
University of Utah
Beaumont Hospital
Loyola University
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00064662
First received: July 10, 2003
Last updated: May 8, 2013
Last verified: May 2013
History of Changes

July 10, 2003
May 8, 2013
February 2002
June 2006   (final data collection date for primary outcome measure)
  • 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success). [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00064662 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence
  • 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.
  • 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
  • Burch
    The Burch colposuspension
    Intervention: Procedure: Burch Modified Tanagho
  • Sling
    Pubovaginal sling, using autologous rectus fascia
    Intervention: Procedure: Autologous Fascia Sling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
655
March 2010
June 2006   (final data collection date for primary outcome measure)
  • 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.
Female
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064662
UITN-RCT (completed)
No
New England Research Institutes
New England Research Institutes
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Maryland
  • University of Pittsburgh
  • University of Texas
  • University of Texas-SanAntonio
  • University of Utah
  • Beaumont Hospital
  • Loyola University
Study Chair: William D. Steers, M.D. University of Virginia
New England Research Institutes
May 2013

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