Clinical trial NCT00064662: Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence
Surgery
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: University of California, San Diego
name: University of Maryland
name: University of Pittsburgh
name: University of Texas
name: The University of Texas at San Antonio
name: University of Utah
name: Beaumont Hospital
name: Loyola University
First posted: 2003-07-11
Enrollment: 655
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).
timeFrame: Two years
measure: 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: University of California
state: California
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas, Southwestern
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Sciences Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Virginia
name: William D. Steers, M.D.
role: STUDY_CHAIR
References:
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