Urinary incontinence affects an estimated 2 to 3 million American men. Men can become incontinent as the result of prostate surgery due to damage of the nervous system controlling the bladder or have leakage due to an enlarged prostate or other medical problems. One method of controlling incontinence is the use of external clamps. Such devices cause pressure to be applied upon the urethra, which consequently stops the flow of urine through the penis but at the same time restricts blood flow to the organ. We have designed a unique clamp that prevents the involuntary loss of urine, allows the user quick, one handed release for voiding or removal and, it is hypothesized, allows adequate blood flow to prevent ischemia. We propose to perform standard urodynamic and blood flow measurements on incontinent males using our device and other commercially available devices. In addition we propose to determine the contact pressure of these devices on the organ.
It is very difficult to estimate the annual usage of male incontinent clamps as it is a very niche market. It is estimated that the device would retail in the $30 to $50 range, comparable to current devices. The initial market for the proposed device will be the prostate cancer patient of whom 90% are incontinent for 2 to 24 weeks post surgery after which we will target the 2 million medically incontinent men. Assuming a 10% and l% market penetration, respectively, BEC's revenues would exceed $800,000.
