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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:
University of Alabama at Birmingham
University of California, San Diego
University of Maryland, College Park
University of Pittsburgh
University of Texas
The University of Texas at San Antonio
University of Utah
Beaumont Hospital
Loyola University
Information provided by (Responsible Party):
New England Research Institutes

Tracking Information
First Submitted Date  ICMJE July 10, 2003
First Posted Date  ICMJE July 11, 2003
Results First Submitted Date  ICMJE March 26, 2012
Results First Posted Date  ICMJE September 28, 2012
Last Update Posted Date May 10, 2013
Study Start Date  ICMJE February 2002
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00064662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
Official Title  ICMJE Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Incontinence
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Burch
    The Burch colposuspension
    Intervention: Procedure: Burch Modified Tanagho
  • Sling
    Pubovaginal sling, using autologous rectus fascia
    Intervention: Procedure: Autologous Fascia Sling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2010)
655
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
650
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date June 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00064662
Other Study ID Numbers  ICMJE UITN-RCT (completed)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party New England Research Institutes
Study Sponsor  ICMJE New England Research Institutes
Collaborators  ICMJE
  • University of Alabama at Birmingham
  • University of California, San Diego
  • University of Maryland, College Park
  • University of Pittsburgh
  • University of Texas
  • The University of Texas at San Antonio
  • University of Utah
  • Beaumont Hospital
  • Loyola University
Investigators  ICMJE
Study Chair: William D. Steers, M.D. University of Virginia
PRS Account New England Research Institutes
Verification Date May 2013

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