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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
Results First Received: March 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urinary Incontinence
Interventions: Procedure: Burch Modified Tanagho
Procedure: Autologous Fascia Sling

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 2002 and June 2004 at nine study sites, 2,405 women were screened: 556 were ineligible, 1,193 declined or withdrew consent and one died.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Burch The Burch colposuspension
Sling Pubovaginal sling, using autologous rectus fascia

Participant Flow:   Overall Study
    Burch     Sling  
STARTED     329     326  
COMPLETED     255     265  
NOT COMPLETED     74     61  
Death                 1                 1  
Lost to Follow-up                 57                 44  
Withdrawal by Subject                 14                 14  
Administratively withdrawn                 2                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Burch The Burch colposuspension
Sling Pubovaginal sling, using autologous rectus fascia
Total Total of all reporting groups

Baseline Measures
    Burch     Sling     Total  
Number of Participants  
[units: participants]
 		  329     326     655  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     289     285     574  
>=65 years     40     41     81  
Age  
[units: years]
Mean ± Standard Deviation 		  52.2  ± 10.5     51.6  ± 10.1     51.9  ± 10.3  
Gender  
[units: participants]
 		     
Female     329     326     655  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     329     326     655  



  Outcome Measures
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1.  Primary:   24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).   [ Time Frame: Two years ]
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2.  Primary:   24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)   [ Time Frame: Two years ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Patients received care at tertiary care centers which could limit the generalizability of the findings. Patients and providers were aware of treatment assignment which could lead to assessment bias.  


Results Point of Contact:  
Name/Title: Anne M. Stoddard, ScD
Organization: New England Research Institutes
phone: 617-972-3331
e-mail: astoddard@neriscience.com


Publications:

Publications automatically indexed to this study:


Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00064662     History of Changes
Other Study ID Numbers: UITN-RCT (completed)
Study First Received: July 10, 2003
Results First Received: March 26, 2012
Last Updated: May 8, 2013
Health Authority: United States: Federal Government