PD23-10 CONVECTIVE RADIOFREQUENCY THERMAL THERAPY: DURABLE TWO-YEAR OUTCOMES OF A RANDOMIZED CONTROLLED AND PROSPECTIVE CROSSOVER STUDY TO RELIEVE LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA

Abstract

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III1 Apr 2017PD23-10 CONVECTIVE RADIOFREQUENCY THERMAL THERAPY: DURABLE TWO-YEAR OUTCOMES OF A RANDOMIZED CONTROLLED AND PROSPECTIVE CROSSOVER STUDY TO RELIEVE LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA Claus Roehrborn, Steven Gange, Marc Gittelman, Kenneth Goldberg, Kalpesh Patel, Neal Shore, Richard Levin, Michael Rousseau, J. Randolf Beahrs, Jed Kaminetsky, Barrett Cowen, Christopher Cantrill, Lance Mynderse, James Ulchaker, Thayne Larson, Christopher Dixon, and Kevin McVary Claus RoehrbornClaus Roehrborn More articles by this author , Steven GangeSteven Gange More articles by this author , Marc GittelmanMarc Gittelman More articles by this author , Kenneth GoldbergKenneth Goldberg More articles by this author , Kalpesh PatelKalpesh Patel More articles by this author , Neal ShoreNeal Shore More articles by this author , Richard LevinRichard Levin More articles by this author , Michael RousseauMichael Rousseau More articles by this author , J. Randolf BeahrsJ. Randolf Beahrs More articles by this author , Jed KaminetskyJed Kaminetsky More articles by this author , Barrett CowenBarrett Cowen More articles by this author , Christopher CantrillChristopher Cantrill More articles by this author , Lance MynderseLance Mynderse More articles by this author , James UlchakerJames Ulchaker More articles by this author , Thayne LarsonThayne Larson More articles by this author , Christopher DixonChristopher Dixon More articles by this author , and Kevin McVaryKevin McVary More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1074AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We report 2-year outcomes of a randomized controlled trial (RCT) plus 1-year results of a crossover trial after treatment with convective radiofrequency (RF) water vapor thermal therapy (Rezum System) for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). RF energy generates wet thermal energy in the form of water vapor that convectively disperses through tissue interstices, remaining confined within prostate zones to achieve rapid ablation of obstructive tissue. METHODS Men ≥ 50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤ 15 ml/s and prostate volume 30-80 cc were randomized 2:1 to RF thermal therapy with the Rezum System and control. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months, control subjects were requalified for the crossover study. The primary endpoint compared IPSS reduction at 3 months and evaluations continued to 24 months RESULTS Mean IPSS was reduced by 50% after RF thermal therapy (-11.2) vs. 20% (-4.3) for control at 3 months (p<0.0001); relief of LUTS remained durable with 51% improvements at 2 years (p<0.0001). The ≥5 (moderate) or ≥8 point (marked) IPSS decreases occurred in 84% and 74% of men through 24 months, respectively; 75% of these had severe LUTS (IPSS ≥19). Qmax increased 68% (6.2 ml/s) at 3 months vs. no change in controls (p <0.0001) and remained significantly improved at 2 years. Crossover subjects (n=53) had IPSS, Qmax and quality of life markedly improved after RF thermal therapy vs. prior control procedure (p <0.024 - <0.0001). Median lobe treatments were performed in 58 of 188 (31%) subjects in both studies; those with and without median lobe ablation achieved similarly reduced IPSS and improved Qmax. Sexual function assessments with the International Index of Erectile Function and Male Sexual Health Questionnaire remained stable. No de novo erectile dysfunction was reported. CONCLUSIONS Convective RF thermal therapy is a minimally invasive office or outpatient procedure requiring minimal anesthesia to achieve early, clinically meaningful LUTS relief and improved flow rate that remain durable for at least 2 years. Therapy is applicable to all obstructed prostate zones including median lobe. Patients experience minimal side effects. Rezum therapy conserves sexual function and presents an attractive alternative for men exploring a nonsurgical option for moderate to severe LUTS/BPH. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e450-e451 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Claus Roehrborn More articles by this author Steven Gange More articles by this author Marc Gittelman More articles by this author Kenneth Goldberg More articles by this author Kalpesh Patel More articles by this author Neal Shore More articles by this author Richard Levin More articles by this author Michael Rousseau More articles by this author J. Randolf Beahrs More articles by this author Jed Kaminetsky More articles by this author Barrett Cowen More articles by this author Christopher Cantrill More articles by this author Lance Mynderse More articles by this author James Ulchaker More articles by this author Thayne Larson More articles by this author Christopher Dixon More articles by this author Kevin McVary More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...