Urinary incontinence affects 15 - 35% of American women and accounts for a direct health care cost of over $26.3 billion per year. It is a major cause of deterioration of quality of life in women as they age. The predominant type of incontinence is called genuine stress urinary incontinence, which is associated with involuntary loss of urine with coughing, sneezing, or laughing. The mainstay of therapy for stress incontinence since the l900s has been to suspend the bladder neck via one of several invasive surgical techniques, which is associated with significant morbidity. A minimally invasive, non-surgical therapy for stress incontinence would provide great advantage. We propose such a solution: the INtraurethral COntinent PROsthesis (INCOPRO). The INCOPRO is an """"""""intelligent"""""""" artificial urethral sphincter which is allows a woman to maintain continence until she desires to void. It is based on a novel helical sphincter design which utilizes conducting polymer technology. In Phase I, we intend to investigate a biomimetic conducting polymer and to build and test a prototype using the helical sphincter design. We will test the INCOPRO in an in vitro model and subsequently in a rabbit model for up to two week use. It is our long-term goal to see the INCOPRO used as an effective minimally invasive solution to the debilitating problem of stress incontinence.
We have interviewed numerous gynecologists and urogynecologists, and found unanimous agreement that a simple office-based solution to the problem of urinary incontinence, such as our device, would be very well received. Given that the direct health care cost of incontinence for women is estimated at $26.3 billion per year, it is safe to say that the commercial potential for INCOPRO is very high.
