Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

Carelon Research655 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

655

Conditions

Urinary Incontinence

Interventions

Burch Modified TanaghoPROCEDURE

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.

Autologous Fascia SlingPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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.

Locations (9)

University of Alabama

Birmingham, Alabama, United States

University of California

San Diego, California, United States

Loyola University Medical Center

Maywood, Illinois, United States

University of Maryland

Outcomes

Primary Outcomes

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.

Time frame: Two years

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.

Time frame: Two years

Data from ClinicalTrials.gov

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