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 Rezūm 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.
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