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UroLift System (NeoTract Inc.) for Treatment of Benign Prostatic Hyperplasia

AT A GLANCE

Focus of Report: This health technology assessment focuses on use of the UroLift System for treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).

Technology Description: The UroLift System is a minimally invasive prostatic urethral lift (PUL) system that provides anterolateral mechanical traction of the lateral lobes of the prostate, opening the urethral lumen, and reducing urinary obstruction. The UroLift System is generally implanted by an urologist in an outpatient setting. The delivery device contains a preloaded implant that deploys, self-adjusts, tensions, and trims a permanent tensioning suture. The suture runs from the urethra to the outer prostatic capsule and serves to compress the lateral lobe of the prostate. Implants are delivered bilaterally to separate the encroaching lobes. Typically, 4 to 5 implants are inserted, but the number varies with the size and shape of the prostate.

Health Problem: BPH is an enlargement or growth of the prostate that affects approximately 8 million men in the United States, including 30% of men older than 50 years of age and nearly 70% of men older than 70 years of age. The enlarged prostate restricts the urethra and applies pressure on the base of the bladder. This restriction of the urethra can result in urination difficulties. BPH is typically diagnosed by the clinical features, including an enlarged prostate and mild-to-severe LUTS, such as obstruction, incomplete emptying, intermittency, weak stream, hesitancy, frequency, urgency, and nocturia. BPH and associated LUTS may result in decreased quality of life (QOL) and depression. Initial treatment for BPH includes pharmacologic therapy; however, 30% of patients require surgical intervention. Current surgical treatment of BPH involves a transurethral resection of the prostate (TURP), an inpatient procedure that requires general or spinal anesthesia and is associated with considerable complications. Less invasive techniques that can be performed as outpatient procedures have been developed in an attempt to reduce associated complications and preserve sexual function.

Patient Population: The UroLift System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to BPH in men ≥ 50 years of age. The UroLift may be used to treat prostate glands measuring < 80 milliliters (mL) in size in the United States and < 100 mL in Europe and Australia.

Evidence Base: The literature search identified 5 clinical studies (n=51 to 206 patients) reported in 13 publications that evaluated the efficacy and safety of PUL using the UroLift System for BPH. Two studies were randomized controlled trials (RCTs), 2 were prospective pretest/posttest studies, and 1 study was a retrospective database review...

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