Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study

OBJECTIVE To report 4-year outcomes of the randomized controlled trial of water vapor thermal therapy for treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia. MATERIALS AND METHODS Total 188 subjects; 135 men >= 50 years old, International Prostate Symptom Score >= 13, maximum flow rate (Qmax) <= 15 mL/s and prostate volume 30 to 80 cc treated with Rezum System thermal therapy were followed 4 years; subset of 53 men who requalified for crossover from control to active treatment were followed 3 years. RESULTS Lower urinary tract symptoms were significantly improved within <= 3 months after thermal therapy and remained consistently durable (International Prostate Symptom Score 47%, quality of life 43%, Qmax 50%, Benign Prostatic Hyperplasia Impact Index 52%) throughout 4 years (P <. 0001); outcomes were similarly sustained in crossover subjects at 3 years. Surgical retreatment rate was 4.4% over 4 years. No disturbances in sexual function were reported. CONCLUSION The minimally invasive thermal therapy provides effective symptom relief and improved quality of life that remains durable for over 4 years. It is applicable to all prostate zones with procedures performed under local anesthesia in an office setting. (C) 2019 The Authors. Published by Elsevier Inc.