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

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Burch Modified Tanagho
Autologous Fascia Sling
Sponsored by
Carelon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Stress urinary incontinence, Surgery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama
  • University of California
  • Loyola University Medical Center
  • University of Maryland
  • Beaumont Hospital
  • University of Pittsburgh
  • University of Texas, Southwestern
  • University of Texas Health Sciences Center
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Burch

Sling

Arm Description

The Burch colposuspension

Pubovaginal sling, using autologous rectus fascia

Outcomes

Primary Outcome Measures

24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).
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)
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.

Secondary Outcome Measures

Full Information

First Posted
July 10, 2003
Last Updated
May 8, 2013
Sponsor
Carelon Research
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
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1. Study Identification

Unique Protocol Identification Number
NCT00064662
Brief Title
Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
Acronym
SISTEr
Official Title
Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Stress urinary incontinence, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
655 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Burch
Arm Type
Other
Arm Description
The Burch colposuspension
Arm Title
Sling
Arm Type
Other
Arm Description
Pubovaginal sling, using autologous rectus fascia
Intervention Type
Procedure
Intervention Name(s)
Burch Modified Tanagho
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Autologous Fascia Sling
Intervention Description
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
Primary Outcome Measure Information:
Title
24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).
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
Title
24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D. Steers, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249-7333
Country
United States
Facility Name
University of California
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Texas, Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9110
Country
United States
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.uitn.net
Description
www.uitn.net

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Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

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