Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of Rezūm Water Vapor Thermal Therapy for Treatment of Moderate-To-Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

OBJECTIVE: To present final 5-year outcomes of the multicenter randomized sham-controlled trial of Rezum water vapor therapy for treatment of moderate-to-severe LUTS due to BPH.
MATERIALS AND METHODS: 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 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 total number of vapor treatments to each lobe of the prostate was determined by length of prostatic urethra and included middle lobe treatment per physician discretion.
RESULTS: Significant improvement of LUTS was observed at <3 months post thermal therapy, remaining durable through 5 years in the treatment group (IPSS reduced 48%, QOL increased 45%, Qmax improved 44%, BPHII decreased 48%. Surgical retreatment rate was 4.4% with no reports of device or procedure related sexual dysfunction or sustained de novo erectile dysfunction. Results within the crossover group were similar through 5 years.
CONCLUSION: Minimally invasive treatment with Rezum 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.

RCT Entities:   Population Interventions Outcomes