title: 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: OBJECTIVE
  This report reveals the results of a multicenter, randomized, controlled study using transurethral prostate convective water vapor thermal energy to treat lower urinary tract symptoms associated with benign prostatic hyperplasia.
  
  
  METHODS
  Men 50 years old or older with an International Prostate Symptom Score of 13 or greater, maximum flow rate of 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 between thermal therapy with the Rezūm® System and control. Thermal water vapor was injected into the transition zone and median lobe as needed. The control procedure was rigid cystoscopy with simulated active treatment sounds. The primary end point compared International Prostate Symptom Score reduction at 3 months. Treatment subjects were followed for 12 months.
  
  
  RESULTS
  There were 197 men randomized (active 136, control 61). Thermal therapy and control International Prostate Symptom Score was reduced by 11.2 ± 7.6 and 4.3 ± 6.9 respectively (p <0.0001). Treatment subject baseline International Prostate Symptom Score of 22 decreased at 2 weeks (18.6, p=0.0006) and by 50% or greater at 3, 6 and 12 months, p <0.0001. The peak flow rate increased by 6.2 ml per second at 3 months and was sustained throughout 12 months (p <0.0001). No de novo erectile dysfunction was reported. Adverse events were mild to moderate and resolved quickly.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Southern Illinois University, Springfield, Illinois. Electronic address: kmcvary@siumed.edu.
authors.forename: Kevin T
authors.initials: KT
authors.lastname: McVary
authors.affiliation: Western Urologic Clinic, Salt Lake City, Utah.
authors.forename: Steven N
authors.initials: SN
authors.lastname: Gange
authors.affiliation: South Florida Medical Research, Aventura, Florida.
authors.forename: Marc C
authors.initials: MC
authors.lastname: Gittelman
authors.affiliation: Texas Urology, Carrollton, Texas.
authors.forename: Kenneth A
authors.initials: KA
authors.lastname: Goldberg
authors.affiliation: Arizona Institute of Urology, Tucson, Arizona.
authors.forename: Kalpesh
authors.initials: K
authors.lastname: Patel
authors.affiliation: Carolina Urologic Research Center, Myrtle Beach, South Carolina.
authors.forename: Neal D
authors.initials: ND
authors.lastname: Shore
authors.affiliation: Chesapeake Urology Research Associates, Towson, Maryland.
authors.forename: Richard M
authors.initials: RM
authors.lastname: Levin
authors.affiliation: The Urology Group, Cincinnati, Ohio.
authors.forename: Michael
authors.initials: M
authors.lastname: Rousseau
authors.affiliation: Metro Urology, Woodbury, Minnesota.
authors.forename: J Randolf
authors.initials: JR
authors.lastname: Beahrs
authors.affiliation: Manhattan Medical Research, New York, New York.
authors.forename: Jed
authors.initials: J
authors.lastname: Kaminetsky
authors.affiliation: Urology Associates of Denver, Englewood, Colorado.
authors.forename: Barrett E
authors.initials: BE
authors.lastname: Cowan
authors.affiliation: Urology San Antonio Research, San Antonio, Texas.
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Cantrill
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Lance A
authors.initials: LA
authors.lastname: Mynderse
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: James C
authors.initials: JC
authors.lastname: Ulchaker
authors.affiliation: Institute of Medical Research, Scottsdale, Arizona.
authors.forename: Thayne R
authors.initials: TR
authors.lastname: Larson
authors.affiliation: Lenox Hill Hospital, New York, New York.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Dixon
authors.affiliation: University of Texas Southwestern, Dallas, Texas.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
mesh_terms: D003558:Cystoscopy; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D006979:Hyperthermia, Induced / Q000379:methods*; D059411:Lower Urinary Tract Symptoms / Q000209:etiology / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011470:Prostatic Hyperplasia / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D013227:Steam; D013997:Time Factors; D020728:Transurethral Resection of Prostate / Q000379:methods*; D016896:Treatment Outcome; D014563:Urodynamics / Q000502:physiology*
chemical_list: D013227:Steam
keywords: lower urinary tract symptoms; prostate; prostatic hyperplasia; thermal conductivity