SBIR-STTR Award

Urinary and fecal incontinence affects 19 percent of Americans over age 60, including 45 percent of those in geriatric institutions. Geriatric incontinence care alone is estimated at $8 billion annually. Research has shown biofeedback training to be a highly effective treatment. A recent project produced an 87-percent reduction in urinary episodes after an average of only 3.5 sessions.A biofeedback system has been designed and breadboarded, integrating proven clinical measures with highly evolved visual and auditory feedback forms. It is the first biofeedback instrument to address the entire pelvic floor, and both urinary and fecal incontinence, which frequently coexist. Long-term objectives are to: (1) establish a treatment system for incontinence sufferers; (2) provide independence and a higher living standard for those afflicted by incontinence; and (3) develop other applications, such as sexual function, for this system.Phase I consists of obtaining the critiques and suggestions of leading clinicians, and integrating this input into the breadboard system to obtain a suitable clinical prototype. Clinical trials and the design of the commercial instrument will be carried out in Phase II.

Anticipated Results:
This instrument will find wide application in private and institutional clinics for behavioral treatment of incontinence disorders. Medical specialties include, but are not limited to, gerontology, urology, gastroenterology, uro-gynecology, rehabilitation, stress management, pediatrics, psychiatry, and psychology.National Institute on Aging

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.