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news.Urovalve, a medical device company, has initiated patient enrollment for a pilot study of its Surinate bladder management system-designed to improve the quality of life of men who suffer from acute or chronic urinary retention, an inability to empty the bladder caused by obstruction of the urethra.
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The pilot study is being conducted at four sites: VA Boston Healthcare System; VA New Jersey Healthcare System; Vanderbilt University Medical Center, Department of Urologic Surgery; and The Virginia Urology Center.
The pilot study is expected to conclude by the end of January 2009. The company intends to commence a pivotal clinical study in the first half of 2009.
Harvey Homan, president and CEO of Urovalve, said: “Urinary retention is a common and distressing condition that can have a profound impact on a man’s quality of life. Men with this condition currently have to rely on a half-century-old product called the Foley catheter, or intermittent catheterization four to six times a day.
“On the other hand, Surinate is designed so that the patient is no longer tethered to an external urine-collection bag; thus no one has to know that the patient has a urinary retention condition.”