Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Abstract

Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

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

“…Clinical evidence after thermal therapy indicates that the patient may expect that IPSS decreases to exceed this minimum AUA response criterion. A moderate symptom improvement (≥5-point decrease in IPSS) was shown to be sustained in 84% of men, and a marked reduction (≥8-point decrease in IPSS) in 74% of patients throughout 2 years in a pivotal trial 11. This level of improvement is superior to that achieved with modern oral pharmaceutical agents and, most importantly, are achieved within the first month after treatment.…”

“…IPSS changes throughout 24 months after convective RF thermal therapy in the RCT11 and pilot study14 and 12 months in the crossover study,11 showing similarity and durability of improvements in the three studies.…”

“…Of the total 188 subjects treated with convective RF thermal therapy in the RCT and crossover studies, a median lobe or elevated bladder neck from CZ hyperplasia was identified in 70/188 (37%) subjects, 58 of these subjects received treatment inclusive of the median lobe at investigators’ discretion 11. Improvements in IPSS and urinary flow in patients with or without a treated median lobe were similar and significant in both cohorts throughout 24 months as compared to baseline.…”

“…Little attention has been paid to understanding the prevalence of PZ/CZ or median zone hypertrophy and contribution to LUTS. In Rezūm clinical trials, 28% of all 253 patients presenting for treatment had a median lobe 11,14. Information on the prevalence of a median lobe in benign hypertrophic prostates was not found but will likely vary as does the individual expressions of LUTS in patients with BPH.…”

Minimally invasive techniques for the treatment of benign prostatic hyperplasia

“…Patients are discharged on the same day of the procedure and should keep an indwelling bladder catheter for 1 week. Available studies to date have demonstrated that, after procedure, there is an increase in urinary flow rate of up to 6 milliliters per second, as well as a 11-point improvement of symptoms as evaluated with the IPSS 18,19 . So far, efficacy of the results has been demonstrated at the end of a 2-year follow-up 19 .…”