Rezūm Therapy Study on Benign Prostatic Hyperplasia (BPH)

By the seventh decade of life, approximately 70% of men have histological evidence of histological stromoglandular hyperplasia, namely benign prostatic hyperplasia (BPH). This hyperplasia is commonly associated with the progressive development of voiding and storage-related lower urinary tract symptoms (LUTS).

In a recent study, researchers have reported that many men with medium-sized glands will experience sustained improvements in BPH symptoms following Rezūm therapy. The study findings were published in The Journal of Urology, April 2021.

This newest Minimally Invasive Surgical Treatment (MIST) is a water vapor thermal therapy using radiofrequency to create thermal energy in the form of water vapor. It was specifically developed as a platform technology for transurethral energy transfer using the convective properties of water, releasing large amounts of stored thermal energy (540 calories/mL H₂O) as the vapor contacts prostate tissue and condenses back to water. Dr. Kevin T. McVary and his team conducted a study to present final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezūm water vapor therapy for the treatment of moderate-to-severe LUTS due to BPH.

The researchers included a total of 197 subjects >50 years of age, with IPSS ≥13, maximum flow rate (Qmax) ≤15 mL/s, and prostate volume 30 to 80 cc. The subjects were randomized and followed for 5 years. From the 61 subject control arm, a subset of 53 subjects requalified and after 3 months, received treatment as part of the crossover group and were also followed for 5 years. The researchers determined the total number of vapor treatments to each lobe of the prostate by the length of the prostatic urethra and included middle lobe treatment per physician discretion.

Key Findings of the Study

• Upon analysis, the researchers observed a significant improvement of LUTS at <3 months post thermal therapy, remaining durable through 5 years in the treatment group (IPSS reduced 48%, Quality of life increased by 45%, Qmax improved 44%, BPHII decreased 48%).
• They noted that the surgical retreatment rate was 4.4%, with no reports of device or procedure-related sexual dysfunction or sustained de novo erectile dysfunction.
• They observed similar results within the crossover group for 5 years.

The authors concluded, "Minimally invasive treatment with Rezūm water vapor thermal therapy provides significant and durable symptom relief as well as flow rate improvements through 5 years, with low surgical retreatment rates and without impacting sexual function. It is a versatile therapy, providing successful treatment to obstructive lateral and middle lobes."

For further information: Read the full study