Convective Water Vapor Thermal Therapy: 3-Year Durable Outcomes of a Randomized Controlled Study for Treatment of Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
Andrew J. Tompkins, MD1; Kevin T. McVary, MD2; Claus G. Roehrborn, MD3.
1Brown University, Providence, RI; 2Southern Illinois University School of Medicine, Springfield, IL; 3University of Texas Southwestern Medical Center, Dallas, TX
Objective: Convective water vapor thermal therapy is a unique minimally invasive procedure for rapid ablation of prostate obstructive tissue including the median lobe and hyperplastic central zone tissue. We report 3-year outcomes of a randomized, controlled trial for treatment of moderate to severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Methods: 197 men ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 mL/s and prostate volume 30 - 80 cc, enrolled in 15 centers were randomized 2:1 to thermal therapy with RezūmŽ System (136) or control (61). Control procedure was rigid cystoscopy with simulated active treatment sound. The total number of treatments in each lobe of the prostate was determined by the length of the prostatic urethra; it can be customized to the configuration of the gland including the median lobe/enlarged central zone. The primary endpoint compared IPSS reductions at 3 months after unblinding; evaluations continued annually for 3 years.
Results: Mean IPSS improvement by 3 months after thermal therapy was -11.2 vs -4.3 points for control (p<0.0001), remaining durable with 50% improvements from baseline throughout 3 years (p<0.001). Commensurate 50% improvements in quality of life and Qmax were sustained over 3 years (p<0.0001). Ablation of the median lobe in 30/135 subjects resulted in significantly decreased PVR. At 36 months PVR decrease was 61% of the mean baseline vs. 18% for subjects without a treated median lobe (p = 0.0109). No late related adverse events occurred; no de novo erectile dysfunction was reported. The surgical retreatment rate was 4.4% (6/135), primarily due to failure to initially treat the median lobe in 4/135 (3%) subjects.
Conclusion: The 3-years results indicate that convective water vapor thermal therapy achieves rapid and durable relief of LUTS, quality of life and flow rates and preservation of sexual function. This office or ambulatory outpatient procedure requires minimal anesthesia; subjects experience minimal transient perioperative side effects. The thermal therapy warrants positioning as a procedure for LUTS relief, both as an initial therapy versus medications and as an alternative to transurethral surgery for selected patients.
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