title: A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia.
abstract: OBJECTIVE
  We assessed the efficacy and tolerability of onabotulinumtoxinA 200 U vs placebo to treat lower urinary tract symptoms/benign prostatic hyperplasia in men previously treated with oral benign prostatic hyperplasia medication in a 24-week phase 2, multicenter, double-blind, randomized, placebo controlled, parallel group trial.
  
  
  METHODS
  Patients with I-PSS (International Prostate Symptom Score) 14 or greater, peak urinary flow rate 4 to 15 ml per second and total prostate volume 30 to 80 ml were randomized 1:1 to a single intraprostatic treatment of onabotulinumtoxinA 200 U or placebo. A single-blind sham procedure followed by a 4-week run-in was included to attempt to minimize any potential placebo effect. Patients who still met eligibility criteria after the run-in entered the double-blind active treatment period. The primary end point was the change from baseline in total I-PSS at week 12. Other end points assessed at weeks 6, 12 and 24 included the change from baseline in total I-PSS, peak urinary flow rate, total prostate volume and post-void residual urine volume.
  
  
  RESULTS
  Of 427 patients enrolled 315 were randomized and treated. Decreases from baseline in I-PSS were observed in the onabotulinumtoxinA and placebo groups (-6.3 vs -5.6 points, p <0.001) with no difference between the groups overall or in subgroups. Improvement was observed in the peak urinary flow rate, which was significant only at week 6 compared to placebo. Improvement was significant at all time points in a patient subgroup on stable concurrent α-blockers or 5α-reductase inhibitors during the study. Adverse events were similar in the 2 treatment groups.
  
  
  CONCLUSIONS
  OnabotulinumtoxinA 200 U and placebo improved I-PSS and were well tolerated but no between group difference in efficacy was observed.
authors: Southern Illinois University School of Medicine, Springfield, Illinois. Electronic address: kmcvary@siumed.edu.
authors: Kevin T
authors: KT
authors: McVary
authors: University of Texas Southwestern Medical Center, Dallas, Texas.
authors: Claus G
authors: CG
authors: Roehrborn
authors: Université Paris 6, Assistance Publique-Hôpitaux de Paris, Paris, France.
authors: Emmanuel
authors: E
authors: Chartier-Kastler
authors: Accumed Research, Inc., Garden City, New York.
authors: Mitchell
authors: M
authors: Efros
authors: Allergan, Inc., Irvine, California.
authors: Denise
authors: D
authors: Bugarin
authors: Allergan, Inc., Irvine, California.
authors: Ru
authors: R
authors: Chen
authors: Allergan, Inc., Irvine, California.
authors: Anand
authors: A
authors: Patel
authors: Allergan, Inc., Irvine, California.
authors: Cornelia
authors: C
authors: Haag-Molkenteller
mesh_terms: D065087:Acetylcholine Release Inhibitors / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications*
chemical_list: D065087:Acetylcholine Release Inhibitors; D019274:Botulinum Toxins, Type A
keywords: benign prostatic hyperplasia; lower urinary tract symptoms; onabotulinumtoxinA; prostate; prostatic hyperplasia