Health Problem: Benign prostatic hyperplasia (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.

Technology Description: The Rezūm System is a minimally invasive, transurethral treatment for BPH that utilizes convective radiofrequency water vapor energy to ablate the hyperplastic tissue. The Rezūm System consists of a radiofrequency power generator and a disposable delivery device. The rigid shaft of the delivery device contains a needle that injects wet thermal energy (i.e., steam) into the diseased prostatic tissue. The steam immediately condenses to water thereby dispersing thermal energy and killing the surrounding cells. The dead cells are eventually absorbed, which reduces the volume of prostatic tissue and opens the urethra.

Controversy: The chief goals of treatment for BPH are the reduction of lower urinary tract symptoms (LUTS) and the prevention of disease progression. Initial treatment includes pharmacologic therapy designed to relieve and limit the progression of symptoms; however, this often provides only modest relief and > 30% of patients require surgical intervention. Transurethral resection of the prostate (TURP), a surgical treatment for BPH, requires general or spinal anesthesia and inpatient hospitalization. TURP is associated with complications, including sexual dysfunction, ejaculatory dysfunction, erectile dysfunction, urinary incontinence, bladder neck contractures, urethral stricture, and septic shock. Less invasive techniques, performed as outpatient procedures, have been developed in an attempt to reduce associated complications and preserve sexual function.

Key Questions:

  • Is the Rezūm System effective for reducing LUTS associated with BPH?
  • How does the Rezūm System compare with alternative treatments for BPH?
  • Is the Rezūm System safe for treatment of BPH?
  • Have definitive patient selection criteria been identified for use of the Rezūm System to treat BPH?

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