Status:
COMPLETED
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
Lead Sponsor:
Uromedica
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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 si...
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 determi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00113555
Start Date
December 1 2001
End Date
November 1 2010
Last Update
July 9 2018
Active Locations (7)
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1
Kaiser Permanente
Los Angeles, California, United States, 90027
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
Lahey Clinic
Burlington, Massachusetts, United States, 01805
4
Metro Urology
Plymouth, Minnesota, United States, 55441