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
The University of Texas at San Antonio
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
Results First Received: March 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   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
No text entered.

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Administratively withdrawn                2                2 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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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 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)
Study First Received: July 10, 2003
Results First Received: March 26, 2012
Last Updated: May 8, 2013