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

PURPOSE:

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.

MATERIALS AND 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: Kevin T McVary, Claus G Roehrborn, Emmanuel Chartier-Kastler, Mitchell Efros, Denise Bugarin, Ru Chen, Anand Patel, Cornelia Haag-Molkenteller
• Journal: The Journal of urology (J Urol) Vol. 192 Issue 1 Pg. 150-6 (Jul 2014) ISSN: 1527-3792 [Electronic] United States
• PMID: 24508634 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Acetylcholine Release Inhibitors
• Botulinum Toxins, Type A

Topics

• Acetylcholine Release Inhibitors (therapeutic use)
• Aged
• Aged, 80 and over
• Botulinum Toxins, Type A (therapeutic use)
• Double-Blind Method
• Humans
• Lower Urinary Tract Symptoms (drug therapy, etiology)
• Male
• Middle Aged
• Prostatic Hyperplasia (complications)