Chronic urinary retention, or the inability to empty the bladder at will, may seem like a mere inconvenience compared to other men’s health issues such as prostate cancer or heart disease. However, men with acute or chronic urinary retention find that the condition limits their normal activities, causes embarrassment, and poses serious health risks. A 2007 study in the British Medical Journal found that men who were admitted to the hospital for acute urinary retention had a death rate three times higher than that of men in the general population.
Current technology to help men with this condition is both dated and inconvenient. Patients either have to rely on a 50-year-old product called the Foley catheter, or undergo intermittent catheterization four to six times a day. The Foley catheter is threaded through the urethra and into the bladder. The patient empties their bladder into an external bag, which must be emptied frequently. In addition, catheterization is known to cause urinary tract infections (UTI). The majority of intermittent catheter users develop a UTI at least once a year. Catheter-related UTIs create health costs of about $3.5 billion per year.
Urovalve of Newark, NJ, seeks to replace catheterization with an updated treatment that returns bladder control to the patient. The Surinate Bladder Management System is designed to free men from the hassles of catheterization, reduce the risk of UTIs, and improve patient quality of life. Surinate consists of a small magnetic valve placed within the urethra. The patient uses a handheld magnet to control the emptying of his bladder. Unlike a catheter, the valve does not extend outside the body, reducing the risk of bacterial migration that can lead to UTIs. Patients are not tied to a bag, and they have total control over the bladder-emptying process.
Over 92 million catheters are sold per year in the U.S., with an estimated global market of $3 billion. Urovalve believes that even a moderate share of the market could realize $800 million in potential sales within five years of launching Surinate. The company recently announced the successful completion of a feasibility study to evaluate the performance and safety of the magnetic valve used in Surinate. The study found that the valve’s performance exceeded expectations and did not pose significant health risks.
Urovalve plans to launch a pilot study with 10 to 20 patients before the year’s end.