Urinary incontinence is a common problem for the elderly affecting approximately 13 million Americans, 80 to 85 percent of them women (15-35% of all adult women) and 15 to 20 percent men (primarily post radical prostethomy). Nearly one third of community-dwelling adults and 750,000 nursing home residents have urinary incontinence. Usually after more conservative approaches have failed, implantation of an artificial urethral sphincter (AUS) is considered and only for patients with stress urinary incontinence.
The Specific Aim of this proposal is to develop, prototype and evaluate an innovative semi-automatic artificial urinary sphincter (AUS) to be used to treat patients with urinary incontinence. Based on preliminary designs and stress evaluations, it is proposed to develop a semi-automated AUS using existing implantable pressure sensors, wireless signaling technology and shape memory alloy (SMA) biocompatible material. The system will monitor bladder pressure and then inform the user when it is time to urinate. The user will then use the control unit to signal the AUS to open and allow micturition. We will evaluate the AUS for longevity of the AUS device when subject to repeated on-off intervals replicating a year of usage. The system will be evaluated in an in-vitro urinary track model. We expect Phase II to proceed with animal trials and eventual human clinical trials. ? ? ? ?
