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

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Experimental	ACT (Adjustable Continence Therapy)	Open Label Study, ACT (Adjustable Continence Therapy)

Primary Outcome Measures

Name	Time	Method
Change of Stamey Grade From Baseline to 12 Months.	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.

Secondary Outcome Measures

Name	Time	Method
Incontinence Impact Questionnaire (IIQ-7)	Baseline to 12 months	Incontinence Impact Questionnaire (IIQ-7) change from baseline to 12 months. Scores range from 0-100. 0 being impact from incontinence, 100 being most impacted from incontinence.
Incontinence Quality of Life (IQoL) Questionnaire	Baseline to 12 months	Change on Incontinence Quality of Life (IQoL) Questionnaire from baseline to 12 months. 0 being lowest quality of life, 100 being highest quality of life.
Number of Incontinence Episodes Per Day (Voiding Diary)	Baseline to 12 months	Change in Number of Incontinence Episodes Per Day from baseline to 12 months. 0 being the best.
Urinary Distress Inventory (UDI-6)	Baseline to 12 months	Change on Urinary Distress Inventory (UDI-6) questionnaire from baseline to 12 months. 0 being not distressed, 100 being very distressed.
Number of Pads Changed Per Day (Voiding Diary)	Baseline to 12 months	Change in Number of Pads Changed Per Day from baseline to 12 months. 0 pads changed a day being the best.
Provocative Pad Weight	Baseline to 12 months	Change in weight of pads (gm) from baseline to 12 months. 0 gm pad weight being the best.

Locations (7): Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Emory University School of Medicine
🇺🇸
Atlanta, Georgia, United States
Metro Urology
🇺🇸
Plymouth, Minnesota, United States
Kansas City Urology Care
🇺🇸
Kansas City, Missouri, United States
CHUS-Fleurimont
🇨🇦
Fleurimont, Quebec, Canada
Can-Med Clinical Research Inc.
🇨🇦
Victoria, British Columbia, Canada
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States