drugset / Trial / NCT00231491
Efficacy and Safety of Botulinum Toxin A for the Treatment of Refractory Overactive Bladder.
RandomizedParallel-groupDouble-blindTreatment
Summary
Overactive bladder induce urgency, urge incontinence, nocturia and pollakiuria. This condition is often resistant to anticholinergic drugs used as a first line treatment for this purpose. Moreover muscarinic side effects (constipation, mouth dryness) often limits the use of those treatments. This study is designed to evaluate the efficacy and safety of botulinum toxin A injected into the detrusor muscle to control symptoms and improve quality of life for patients resistant or intolerant to anticholinergic drugs.
Timeline
- Start
- 2005-11
- Primary completion
- 2010-04
- Completion
- 2010-04
Publications
- Background Rajkumar GN, Small DR, Mustafa AW, Conn G. A prospective study to evaluate the safety, tolerability, efficacy and durability of response of intravesical injection of botulinum toxin type A into detrusor muscle in patients with refractory idiopathic detrusor overactivity. BJU Int. 2005 Oct;96(6):848-52. doi: 10.1111/j.1464-410X.2005.05725.x.
- Denys P, Le Normand L, Ghout I, Costa P, Chartier-Kastler E, Grise P, Hermieu JF, Amarenco G, Karsenty G, Saussine C, Barbot F; VESITOX study group in France. Efficacy and safety of low doses of onabotulinumtoxinA for the treatment of refractory idiopathic overactive bladder: a multicentre, double-blind, randomised, placebo-controlled dose-ranging study. Eur Urol. 2012 Mar;61(3):520-9. doi: 10.1016/j.eururo.2011.10.028. Epub 2011 Oct 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 50 iu | Other |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 150 iu | Other |