Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Completed · Not applicable
Conditions studied: Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT00113555
- Run by
- Uromedica
- People needed
- 221
- Starts
- 2001-12-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2018-07-09
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
- Kansas City Urology Care — Kansas City, Missouri, United States
- Can-Med Clinical Research Inc. — Victoria, British Columbia, Canada
- CHUS-Fleurimont — Fleurimont, Quebec, Canada
Full record on ClinicalTrials.gov
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