Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Incontinence
Interventions Procedure: Burch Modified Tanagho
Procedure: Autologous Fascia Sling
Enrollment 655
Recruitment Details 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  
Arm/Group Title Burch Sling
Hide Arm/Group Description The Burch colposuspension Pubovaginal sling, using autologous rectus fascia
Period Title: Overall Study
Started 329 326
Completed 255 265
Not Completed 74 61
Reason Not Completed
Death             1             1
Lost to Follow-up             57             44
Withdrawal by Subject             14             14
Administratively withdrawn             2             2
Arm/Group Title Burch Sling Total
Hide Arm/Group Description The Burch colposuspension Pubovaginal sling, using autologous rectus fascia Total of all reporting groups
Overall Number of Baseline Participants 329 326 655
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 326 participants 655 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
289
  87.8%
285
  87.4%
574
  87.6%
>=65 years
40
  12.2%
41
  12.6%
81
  12.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 329 participants 326 participants 655 participants
52.2  (10.5) 51.6  (10.1) 51.9  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 329 participants 326 participants 655 participants
Female
329
 100.0%
326
 100.0%
655
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 329 participants 326 participants 655 participants
329 326 655
1.Primary Outcome
Title 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).
Hide Description 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.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were included in time to event analysis.
Arm/Group Title Burch Sling
Hide Arm/Group Description:
The Burch colposuspension
Pubovaginal sling, using autologous rectus fascia
Overall Number of Participants Analyzed 329 326
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % success at 24 months
38
(32 to 44)
47
(41 to 53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Burch, Sling
Comments Time to event analysis of 24 month success rates. Null hypothesis is that the distributions in the two groups are equal.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Other
Estimated Value 0
Estimation Comments [Not Specified]
2.Primary Outcome
Title 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)
Hide Description 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.
Time Frame Two years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants randomized were included in time to event analysis
Arm/Group Title Burch Sling
Hide Arm/Group Description:
The Burch colposuspension
Pubovaginal sling, using autologous rectus fascia
Overall Number of Participants Analyzed 329 326
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: % stress-specific success at 24 m
49
(43 to 55)
66
(60 to 71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Burch, Sling
Comments Time to event analysis of cumulative success rates in the two groups. Null hypothesis is that the distributions are equal in the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Chi-square
Estimated Value 16.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Burch, Sling
Comments Kaplan Meier time-to-event analysis of cumulative success rates. Used Wald test of equality of survival distributions.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kalpan Meier (Wald statistic)
Comments [Not Specified]
Method of Estimation Estimation Parameter Other
Estimated Value 0
Estimation Comments [Not Specified]
Time Frame 24 months
Adverse Event Reporting Description Site principal investigators reported adverse events to the adverse events committee comprised of four investigators who were blinded to site-specific information, including surgeon and study procedure. All adverse events were reviewed by the committee assigned a severity code.
 
Arm/Group Title Burch Sling
Hide Arm/Group Description The Burch colposuspension Pubovaginal sling, using autologous rectus fascia
All-Cause Mortality
Burch Sling
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Burch Sling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/329 (9.73%)      42/326 (12.88%)    
Gastrointestinal disorders     
Gastrointestinal   1/329 (0.30%)  1 1/326 (0.31%)  1
Injury, poisoning and procedural complications     
Pelvic pain   0/329 (0.00%)  0 2/326 (0.61%)  2
Bleeding   3/329 (0.91%)  3 1/326 (0.31%)  1
Wound complication requiring surgical intervention   12/329 (3.65%)  13 10/326 (3.07%)  11
Renal and urinary disorders     
Genitourinary   18/329 (5.47%)  22 29/326 (8.90%)  30
Respiratory, thoracic and mediastinal disorders     
Respiratory distress requiring intubation   0/329 (0.00%)  0 1/326 (0.31%)  1
Laryngospasm requiring reintubation   0/329 (0.00%)  0 1/326 (0.31%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Burch Sling
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   156/329 (47.42%)      206/326 (63.19%)    
Cardiac disorders     
Cardiovascular   0/329 (0.00%)  0 2/326 (0.61%)  2
Gastrointestinal disorders     
Gastrointestinal   7/329 (2.13%)  7 8/326 (2.45%)  8
General disorders     
Constitutional   3/329 (0.91%)  3 0/326 (0.00%)  0
Injury, poisoning and procedural complications     
Wound complication not requiring surgical intervention   62/329 (18.84%)  69 66/326 (20.25%)  71
Nervous system disorders     
Neurologic   6/329 (1.82%)  6 5/326 (1.53%)  5
Renal and urinary disorders     
Genitourinary   105/329 (31.91%)  203 157/326 (48.16%)  305
Respiratory, thoracic and mediastinal disorders     
Pulmonary   10/329 (3.04%)  10 9/326 (2.76%)  9
Skin and subcutaneous tissue disorders     
Allergic (hives, itching)   0/329 (0.00%)  0 2/326 (0.61%)  2
Dermatologic (rash, erythema)   2/329 (0.61%)  2 4/326 (1.23%)  4
Vascular disorders     
Vascular/ Hematologic   5/329 (1.52%)  5 9/326 (2.76%)  9
Indicates events were collected by systematic assessment
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.
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
Layout table for Results Point of Contact information
Name/Title: Anne M. Stoddard, ScD
Organization: New England Research Institutes
Phone: 617-972-3331
EMail: astoddard@neriscience.com
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00064662     History of Changes
Other Study ID Numbers: UITN-RCT (completed)
First Submitted: July 10, 2003
First Posted: July 11, 2003
Results First Submitted: March 26, 2012
Results First Posted: September 28, 2012
Last Update Posted: May 10, 2013