Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence

Uromedica221 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence. The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.

This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

221

Conditions

Urinary Incontinence

Interventions

ACT (Adjustable Continence Therapy)DEVICE

surgically implanted device

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women * 18 years or older * Diagnosed with stress urinary incontinence with or without urethral hypermobility * Willing to sign informed consent * Candidates for surgical intervention for stress incontinence * Negative urinalysis or urine culture within 2 weeks of implantation * Normal cystourethroscopy * Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.) * May have failed suspension or sling procedures Exclusion Criteria: * Pregnant or lactating * Life expectancy of less than one year * Insulin dependant diabetic * Auto-immune disease * Undergoing radiation therapy * Active urinary tract infection * Detrusor instability refractory to meds * Reduced bladder compliance * Significant bladder residual \>100mls * Bladder cancer * Unsuccessfully treated bladder stones * Current urethral stricture preventing the passage of a 24 French endoscope * Neurogenic bladder * Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher * Prior pelvic radiotherapy * Artificial urinary sphincter implanted

Locations (7)

Kaiser Permanente

Los Angeles, California, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Lahey Clinic

Burlington, Massachusetts, United States

Metro Urology

Plymouth, Minnesota, United States

Outcomes

Primary Outcomes

Change of Stamey Grade From Baseline to 12 Months.

The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.