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.

Condition	Intervention	Phase
Urinary Incontinence	Device: ACT (Adjustable Continence Therapy)	Phase II Phase III

Further Study Details: 

Primary Outcomes: Efficacy: Determine whether use of the ACT device results in a mean reduction from baseline in Stamey score of greater than or equal to one grade at twelve months post implant.; Safety: Characterize the frequency of complications that occur among subjects implanted with the ACT system at the time of the procedure and continuing through the 12-month follow-up.
Secondary Outcomes: Assess the clinical utility of the ACT device in improving patient''''s quality of life.; Characterize the safety of the ACT device by quantifying the risk of anticipated and unanticipated adverse events.; Evaluate the technical feasibility of the delivery system to position the prosthetic at the bladder neck.; To assess the ability to adjust the amount of urethral coaptation and bladder neck support post-operatively.
Expected Total Enrollment:  160

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

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 FR endoscope
• Neurogenic bladder
• Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
• Prior pelvic radiotherapy
• Artificial urinary sphincter implanted

Please refer to this study by ClinicalTrials.gov identifier  NCT00113555

Diane Burnside      763-694-9880    dburnside@uromedica-inc.com

Louisiana
      Neil Baum Urology, New Orleans,  Louisiana,  70115,  United States; Recruiting

Study chairs or principal investigators

Tim Cook,  Study Director,  Uromedica, Inc.   

Study ID Numbers:  URM01-01-01
Record last reviewed:  June 2005
Last Updated:  June 8, 2005
Record first received:  June 8, 2005
ClinicalTrials.gov Identifier:  NCT00113555
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-06-21