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

May 8, 2013 updated by: HealthCore-NERI

Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

655

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-7333
        • University of Alabama
    • California
      • San Diego, California, United States, 92037
        • University of California
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75390-9110
        • University of Texas, Southwestern
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Sciences Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Burch
The Burch colposuspension
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.
Other: Sling
Pubovaginal sling, using autologous rectus fascia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Two years
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.
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

University of California, San Diego
University of Maryland
University of Alabama at Birmingham
University of Pittsburgh
University of Texas
University of Utah
Loyola University
The University of Texas at San Antonio
Beaumont Hospital

Investigators

  • Study Chair: William D. Steers, M.D., University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

July 10, 2003

First Submitted That Met QC Criteria

July 10, 2003

First Posted (Estimate)

July 11, 2003

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UITN-RCT (completed)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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