Urovalve Bladder Management System Shows Early Promise in Clinical Trial

toiletNewark, New Jersey-based medical device company Urovalve recently announced promising early results in a multi-site clinical trial of its Surinate Bladder Management System. The Surinate system is designed to treat men who suffer from acute and chronic urinary retention, an inability to empty the bladder. Out of 13 patients who had the Surinate catheter inserted, all were able to successfully use the device to empty the bladder for more than 24 hours. Subjects kept the device in for a mean period of 14.1 days, and no damage to the urethra was observed.

Men who experience chronic urinary retention usually relieve themselves using a 60-year-old product called a Foley catheter attached to a urine collection bag, or undergo intermittent catheterization four to six times a day. A urine collection bag can be inconvenient and embarrassing for patients, and catheterization may cause discomfort and lead to urinary tract infections. The majority of intermittent catheter users develop a UTI at least once a year.

The Surinate system consists of a magnetic valve inside a catheter that allows the bladder to fill. Once the patient is ready to empty his bladder, he uses an external magnet to open the valve and drain his bladder. The system gives the patient control over his bladder-emptying process and eliminates the need for a collection bag. The Surinate catheter is designed to remain in the body for 30 days. According to Urovalve president Harvey D. Homan, reaching this 30-day milestone is a primary endpoint of the current trial.

Chronic urinary retention is more than just a socially embarrassing, inconvenient condition. In addition to UTIs associated with catheterization, chronic urinary retention may cause bladder damage and chronic kidney disease over time. Chronic urinary retention can be caused by a wide variety of conditions and diseases. One common cause of urinary retention in men is benign prostatic hyperplasia, or an enlarged prostate gland. As men age, the prostate naturally becomes larger and may press against the urethra. Over time, this can weaken the bladder’s ability to empty itself. Over 23 million  men worldwide suffer from benign prostatic hyperplasia.

Minneapolis-based Urologix is among the companies developing a treatment for benign prostatic hyperplasia. The company’s Cooled ThermoTherapy technology uses targeted microwave energy to heat and destroy enlarged prostate tissue while a cooling mechanism protecting the healthy surrounding tissue. Approximately 225,000 patients worldwide have undergone the treatment so far. Nymox Pharmaceutical Corporation is advancing an investigational drug to treat benign prostatic hyperplasia; the drug is currently in Phase III trials. Other companies working to treat this condition include Focus Surgery, AndroScience Corporation, Protox Therapeutics, and ProstaLund.

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