The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia.
As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia. When the prostate is enlarged it can restrict or block urine flow. The UroLift system relieves the urine flow by pulling back the prostate tissue that is pressing on the urethra.
More than half of all men in their 60s and as many as 90% of men in their 70s and 80s have some symptoms of benign prostatic hyperplasia, such as more frequent urination with hesitant, interrupted, or weak stream and urgency and leaking. Severe benign prostatic hyperplasia can lead to serious problems over time, such as strain on the bladder, urinary tract infections, bladder or kidney damage, bladder stones, and incontinence. Current treatment options to relieve symptoms associated with benign prostatic hyperplasia include drug therapy or surgical procedures including removal of the enlarged part of the prostate.
“The UroLift provides a less invasive alternative to treating [benign prostatic hyperplasia] 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.”
The FDA’s review of the UroLift system included data from two clinical studies of men with benign prostatic hyperplasia implanted with two or more UroLift sutures. The first study included 64 men between the ages of 53 and 83, and the second study included 210 men between the ages of 49 and 86. Both studies showed that physicians successfully inserted UroLift in 98% of participants.
The studies also measured participant urine flow and ability to empty the bladder, and throughout the study period, found a 30% increase in urine flow and a steady amount of residual urine in the bladder. Study participants answered validated questionnaires about their benign prostatic hyperplasia–related symptoms and quality of life, reporting a decrease in symptoms and an increase in quality of life in the 2 years following treatment.
Minor adverse events reported 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. Investigators did not report any serious device-related adverse events.
The FDA reviewed the UroLift system through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.
The UroLift System is manufactured by NeoTract Inc of Pleasanton, California. ■