Incontinence affects at least 12 million Americans, at a cost of more than $10 billion annually. A significant percentage can be cured or improved through Neuromuscular Retraining techniques (Biofeedback). The 1988 NIH Consensus Development Conference on Urinary incontinence stated: Behavioral techniques should be tried first, unless contraindicated. Biofeedback serves as an alternate and/or adjunct therapy to surgery and Pharmacology. Long term objectives of this research are: 1. Establish a Biofeedback treatment system for Incontinence. 2. Provide independence and a higher quality of life for those afflicted. 3. Develop other applications, such as : Irritable Bowel Syndrome, Prostatitis, and Sexual Function for this system. Commercial Potential: 5000 clinical stations are required to treat today's domestic incontinent populations. Prospects for export are excellent. Phase I solicited critique of the breadboard instrument by clinicians, through demonstrations and a questionnaire. Phase II begins with construction of Clinical Prototype Instruments. Clinical trials will be conducted at several Medical Centers currently treating Incontinence. Comparisons will be made with previous instrumentation. Open-ended and Structured critique operational factors by Patient and Clinician Staff will be gleaned toward a final refinement. A pre-production model will be assigned, constructed, and clinically evaluated. Production documentation and preparation for FDA submission will conclude Phase II.
