Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with RezĹ«m system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia
Authors Darson MF, Alexander EE, Schiffman ZJ, Lewitton M, Light RA, Sutton MA, Delgado-Rodriguez C, Gonzalez RR
Received 10 June 2017
Accepted for publication 31 July 2017
Published 21 August 2017 Volume 2017:9 Pages 159—168
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Akshita Wason
Peer reviewer comments 2
Editor who approved publication: Dr Jan Colli
Micheal F Darson,1 Erik E Alexander,1 Zvi J Schiffman,2 Michael Lewitton,2 Robert A Light,2 Mark A Sutton,2 Carlos Delgado-Rodriguez,2 Ricardo R Gonzalez2
1Arizona Urology Specialists, Scottsdale, AZ, 2Houston Metro Urology, Houston, TX, USA
Objective: This report evaluates clinical experience with the RezĹ«m system after US Food and Drug Administration clearance in consecutive cases accrued by multiple community urologists for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Treatment techniques for transurethral convective radiofrequency water-vapor thermal therapy and outcomes with up to 12 months’ follow-up are presented.
Materials and methods: A total of 131 patients with moderate–severe LUTS were included in a retrospective analysis of BPH procedures with the RezĹ«m system. Pre- and postprocedure assessments included International Prostate Symptom Score (IPSS), quality of life, peak urinary flow rate, voided volume, and postvoid residual urine volume. Urologists used their own discretion for patient selection, with variable prostate sizes, LUTS severity, urinary retention, or presence of an obstructing median lobe. Safety signals and surgical retreatment rates were monitored prospectively.
Results: Men aged 47–96 years with prostates 13–183 cm3 showed significant improvement in IPSS, quality of life, and postvoid residual volume durable through 12 months after thermal therapy. Patients with either moderate (IPSS 8–19) or severe (IPSS 20–35) symptoms achieved significantly improved scores. Postprocedure adverse events normally anticipated and related to endoscopic instrumentation were transient and mild–moderate in nature. No de novo erectile or ejaculatory dysfunction was reported.
Conclusion: This study corroborates prior published pilot and randomized controlled trial results indicating significant relief of urinary symptoms and reproducibility of responses to thermal therapy. Convective radiofrequency thermal therapy with the RezĹ«m system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.
Keywords: prostate, prostatic hyperplasia, lower urinary tract symptoms, convective RF thermal therapy, minimally invasive procedure
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