U.S. FDA Gives Urolift the Green Light for BPH Treatment

by | Sep 16, 2013 | Blog, Procedures, Technology News

The US Food and Drug Administration recently approved Urolift, a new minimally invasive treatment for men who suffer blocked urine flow due to an enlarged prostate.

The Urolift system is manufactured by NeoTract Inc., California, and is the first permanent implant to relieve partially or completely blocked urine flow in men aged 50 and over with BPH.

Benign prostatic hyperplasia (BHP) is also known as prostate enlargement and has traditionally been treated with drug therapy or surgery. Commonly used medications include alpha blockers or 5 alpha reductase inhibitors that can cause side effects and don’t always result in adequate urinary symptom relief.

The prostate is a walnut sized gland which sits below the bladder. As men with BHP get older the prostate will increase in size and partially or completely block the urethra. The Urolift works by holding the lateral lobes of the prostate apart to increase the diameter of the urethra to significantly improve a man’s urinary function.

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

Until now the Urolift system has only been available in select centers in Europe, Canada and Australia. The U.S. FDA’s approval was largely a result of two clinical studies conducted on men with BPH who were implanted with two or more Urolift sutures.

The studies of 264 men aged between 40 and 86 showed a 30% increase in urine flow and a 98% implant success rate. Minor effects in some men included pain and burning while urinating, some blood in the urine, frequent need to urinate and incomplete bladder emptying. Investigators say that these symptoms were not device related.

Urolift provides men suffering from BHP with a less invasive treatment that is much easier to recover from. The benefits of Urolift include avoiding the side effects of medication, a more sustained urinary function improvement and avoiding sexual complications.