OBJECTIVETo 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 METHODSTotal 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.
RESULTSLower 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. UROLOGY 126: 171−179, 2019. B y 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 progressive development of voiding and storage related lower urinary tract symptoms (LUTS). Several options exist for BPH management with a significant range of invasiveness, efficacy, and cost. The therapy a patient pursues should rely on careful physical evaluation and informed discussion with his provider. Decision making varies according to severity of symptoms, gland size, anatomical features, and efficacy and safety of the different treatments. Minimally invasive surgical treatments (MISTs), both thermal and mechanical expander options, represent alternative intervention before or after any pharmacotherapy.The newest MIST is water vapor thermal therapy using radiofrequency to create thermal energy (Rezum System, Boston Scientific, Marlborough, MA) in the form of water vapor. This therapy 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 H 2 O) as the vapor contacts prostate tissue and condenses back to water.