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

Abstract

Convective water vapor thermal therapy provides rapid and durable improvements in benign prostatic hyperplasia 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 the median lobe.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

“…The results from this open-label study of convective RF water vapor thermal therapy are consistent with the recently published results from a randomized study with a similar reduction in IPSS at 1 year (−11.7 vs. −12.5 points observed in the present study) 13. This provides evidence of stability and durability for this minimally invasive thermal procedure with a continuing IPSS reduction of 12.1 points at 2 years.…”

“…Analyses of randomized, controlled clinical trials for LUTS/BPH with drugs, endoscopic procedures, and surgeries have shown that placebo effects are to be considered in evaluating the outcomes of active treatments 21,22. However, as the improvements in IPSS and Q max in this study are comparable to those observed in the prospective, controlled pivotal convective RF thermal therapy trial, and similarly durable,13 the validity of the therapeutic responses are substantiated.…”

“…The IPSS reductions documented in this pilot study closely resemble those in a previously published randomized controlled study of convective RF thermal therapy in which mean reductions of ~12 points (≥50%) were documented over 12 months (Figure 2). 13…”

“…The procedure was performed utilizing the Rezūm System previously described in detail 10–13. Briefly, water vapor thermal energy is created with RF current against an inductive coil heater in the handle of the device.…”

<div>Perspective on the Rezūm^&reg; System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy</div>

“…A registration-directed pivotal, randomized controlled trial (Rezūm II RCT) of the convective RF water vapor thermal therapy was conducted to evaluate the effectiveness and safety of the Rezūm System for the treatment of men with moderate-to-severe LUTS associated with BPH 19. The study compared thermal therapy with a control/sham procedure of rigid cystoscopy and simulated active treatment sounds.…”