Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Timeline

Start

2009-09

Primary completion

2011-08

Completion

2011-08

Outcome

Met primary endpoint

paper OnabotulinumtoxinA significantly decreased UI episodes per day at week 12 (-2.95 for onabotulinumtoxinA versus -1.03 for placebo; p<0.001). PMID 23608668 ↗

Publications

• Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5.
• Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.
• Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.

Drugs

Indications