Minimally Invasive Prostate Convective Water Vapor Energy (WAVE) Ablation: A Multicenter, Randomized, Controlled Study for Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

This report reveals results of a multicenter randomized-control study utilizing transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).

Men 50 years old or greater with International Prostate Symptom Scores (IPSS) 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary endpoint compared IPSS reduction at 3 months. Treatment subjects were followed for 12 months.

There were 197 men randomized (active 136, control 61). Thermal therapy and control IPSS was reduced by 11. 2 ± 7. 6 and 4. 3 ± 6. 9 respectively (p<0. 0001). Treatment subject baseline IPSS of 22 decreased at 2 weeks (18. 6, p=0. 0006) and by 50% or greater at 3, 6 and 12 months, p<0. 0001. Peak flow rate increased by 6. 2 ml per second at 3 months and was sustained throughout 12 months (p<0. 0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly.

Convective water vapor thermal therapy treatment provides rapid and durable improvements in BPH symptoms and preserves erectile and ejaculatory function. Treatment can be delivered in an office or hospital setting using oral pain medication and is applicable to all prostate zones including median lobe.

The Journal of urology. 2015 Nov 22 [Epub ahead of print]

Kevin T McVary, Steven N Gange, Marc C Gittelman, Kenneth A Goldberg, Kalpesh Patel, Neal D Shore, Richard M Levin, Michael Rousseau, J Randolf Beahrs, Jed Kaminetsky, Barrett E Cowan, Christopher H Cantrill, Lance A Mynderse, James C Ulchaker, Thayne R Larson, Christopher M Dixon, Claus G Roehrborn