Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

Phase 2 Completed 380 enrolled Allergan

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study was to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia.

Timeline

Start: 2005-12
Primary completion: 2009-05
Completion: 2010-05

Outcome

Missed primary endpoint

paper in IPSS, Q(max), TPV, and TZV were observed for all groups, including placebo, at week 12 (p<0.001), with no significant differences between onabotulinumtoxinA and placebo. PMID 23098762 ↗

Publications

Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	100 iu	Intrathecal
Subject	Botulinum toxin type A	Protein / enzyme biologic	200 iu	Intrathecal
Subject	Botulinum toxin type A	Protein / enzyme biologic	300 iu	Intrathecal