title: Phase I/II examination of transurethral ethanol ablation of the prostate for the treatment of symptomatic benign prostatic hyperplasia.
abstract: OBJECTIVE
  We assessed the safety of transurethral ethanol ablation of the prostate as a treatment for men with symptomatic benign prostatic hyperplasia and determined the efficacy of this procedure.
  
  
  METHODS
  We performed a multicenter randomized trial on 79 men, 50 to 79 years old, who had drug refractory voiding symptoms (International Prostate Symptom Score greater than 12) and prostate volumes of 30 to 80 cc. Ethanol was injected transurethrally into the prostate with a curved cystoscopic needle in men randomly assigned to 1 of 3 doses: 15%, 25% or 40% of prostate volume by transrectal ultrasound. Followup evaluations were performed 1, 3 and 6 months later. Postoperative cystoscopy was performed on all patients to evaluate ablation extent and extraprostatic effects. Transrectal ultrasound volume determinations were obtained before and 6 months after transurethral ethanol ablation of the prostate.
  
  
  RESULTS
  Adverse events were generally mild or moderate, and included hematuria (42.9%), irritative voiding symptoms (40.3%), pain/discomfort (25.6%) and urinary retention (22.1%). No serious adverse events were reported. Statistically significant improvements were seen in International Prostate Symptom Score, quality of life, maximum flow rate and prostate volume reduction (p<0.05). Improvements were consistently observed across the 3 groups without an apparent dose effect.
  
  
  CONCLUSIONS
  In this randomized clinical trial transurethral ethanol ablation of the prostate was safe and effective at 6-month followup. No serious adverse events were encountered. Although ethanol can safely ablate prostatic tissue, further studies will be necessary before widespread clinical application.
authors.affiliation: University of Vermont College of Medicine, Burlington, Vermont 05405, USA. mark.plante@uvm.edu
authors.forename: M K
authors.initials: MK
authors.lastname: Plante
authors.forename: L S
authors.initials: LS
authors.lastname: Marks
authors.forename: R
authors.initials: R
authors.lastname: Anderson
authors.forename: C
authors.initials: C
authors.lastname: Amling
authors.forename: D
authors.initials: D
authors.lastname: Rukstalis
authors.forename: G
authors.initials: G
authors.lastname: Badlani
authors.forename: L
authors.initials: L
authors.lastname: Getlin
authors.forename: E
authors.initials: E
authors.lastname: Vang
mesh_terms: D000368:Aged; D003558:Cystoscopy; D004305:Dose-Response Relationship, Drug; D000431:Ethanol / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D012997:Solvents / Q000008:administration & dosage*; D016896:Treatment Outcome; D014521:Urethra
chemical_list: D012997:Solvents; D000431:Ethanol