Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH): Durable 4-Year Results from Randomized Controlled Study
Andrew J. Tompkins, MD1, Kevin McVary, MD2, Claus Roehrborn, MD3
1Urology, Brown University, Plainville, MA, 2Stritch School of Medicine, Loyola University Medical, Chicago, IL, 3University of Texas Southwestern Medical Center, Dallas, TX
Introduction: A randomized controlled trial of water vapor thermal therapy was conducted to treat moderate to severe LUTS/BPH and to determine minimal important differences in International Prostate Symptom Scores (IPSS) associated with perceptible changes in quality of life (QOL). Methods: Total 188 subjects in active arm: 135 men ≥50 years old, IPSS ≥13, maximum flow rate (Qmax) ≤15 ml/s and prostate volume 30 to 80 cm3 treated with RezūmŽ System thermal therapy were followed 4 years; subset of 53 men, requalified for crossover from control to active treatment were followed 3 years. Results: IPSS, QOL, Qmax and BPH Impact Index improved ~50% and remained consistently durable throughout 4 years, p < .0001 (Figure); crossover subjects had similar sustained outcomes. At 4 years surgical retreatment rate was 4.4%, BPH medication resumption rate was 5.2%. Sexual function was preserved. IPSS and QOL scores strongly correlated; a mean IPSS change corresponding to a 1-point QOL improvement is ~ -5 points for IPSS 13-19, -8.2 for IPSS 20-26, -11.7 for severest LUTS of IPSS 27-35. Conclusion: Rezūm thermal therapy provides effective symptom relief and improved QOL with durability over 4 years, has limited impact on sexual function and is applicable to all prostate zones with procedures performed under local anesthesia in an office setting.
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