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.
Primary Outcome Measures:
- 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. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- 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. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Assess the clinical utility of the ACT device in improving patient's quality of life. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- Characterize the safety of the ACT device by quantifying the risk of anticipated and unanticipated adverse events. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- Evaluate the technical feasibility of the delivery system to position the prosthetic at the bladder neck. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- To assess the ability to adjust the amount of urethral coaptation and bladder neck support post-operatively. [ Time Frame: 2009 ] [ Designated as safety issue: No ]
| Estimated Enrollment: |
160 |
| Study Start Date: |
December 2001 |
| Estimated Study Completion Date: |
July 2009 |
| Primary Completion Date: |
July 2008 (Final data collection date for primary outcome measure) |
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Experimental: Experimental
Open Label Study
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Device: ACT (Adjustable Continence Therapy)
surgically implanted device
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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.
Purpose
