FDA Approves Marketing New Device To Treat Urinary Symptoms Related to Enlarged Prostate

First Posted: Sep 16, 2013 04:32 AM EDT
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The FDA has approved marketing of a new device that can be used to treat urinary symptoms related to enlarged prostate.

The device, known as UroLift system is the first machine that can be used to relieve low or blocked urine flow in men of age 50 and older, who suffer from enlarged prostate.

The prostate gland is located below the bladder in men. As men begin to age, this gland also begins to enlarge leading to a condition scientifically known as benign prostatic hyperplasia (BPH). Enlargement of the gland leads to restricted or blocked urine flow. More than half of all men in their sixties and more than 90 percent of men in their seventies and eighties have some symptoms of BPH like frequent urination with hesitant, interrupted or weak stream, poor bladder control and leaking.

Current treatment options to relieve symptoms associated with BPH include drug therapy or surgical procedures including removal of the enlarged part of the prostate.

"The UroLift provides a less invasive alternative to treating BPH than surgery," said Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health. "This device also may offer relief to men who cannot tolerate available drug therapies." 

Marketing approval was provided after the FDA conducted two clinical studies of men with BPH implanted with UroLift. Researchers observed a 30 percent increase in urine flow and a steady amount of residual urine in the bladder.

Some of the adverse effects of using the device included pain or burning during urination, blood in the urine, frequent or urgent need to urinate, incomplete emptying of the bladder, and decreased urine flow. However, investigators didn't find any serious side effects of using the device.

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