title: 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: We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia.
  
  
  
  A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores.
  
  
  
  Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at 24 months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p = 0.024 to <0.0001). No de novo erectile dysfunction was reported.
  
  
  
  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.
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas. Electronic address: Claus.roehrborn@utsouthwestern.edu.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Steven N
authors.initials: SN
authors.lastname: Gange
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Marc C
authors.initials: MC
authors.lastname: Gittelman
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Goldberg
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Kalpesh
authors.initials: K
authors.lastname: Patel
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Neal D
authors.initials: ND
authors.lastname: Shore
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Levin
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Michael
authors.initials: M
authors.lastname: Rousseau
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: J Randolf
authors.initials: JR
authors.lastname: Beahrs
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Jed
authors.initials: J
authors.lastname: Kaminetsky
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Barrett E
authors.initials: BE
authors.lastname: Cowan
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Cantrill
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Lance A
authors.initials: LA
authors.lastname: Mynderse
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: James C
authors.initials: JC
authors.lastname: Ulchaker
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Thayne R
authors.initials: TR
authors.lastname: Larson
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Dixon
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center (CGR), Dallas, Texas.
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
mesh_terms: D018481:Convection; D018592:Cross-Over Studies; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications; D000078702:Radiofrequency Therapy / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome
keywords: convection; lower urinary tract symptoms; prostate; prostatic hyperplasia