NEUROTOX: Two Dosages of Type A Botulinic Toxin in Neurogenic Overactive Bladder

Phase 2 Terminated 80 enrolled University Hospital, Rouen

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine the efficacy and tolerance of 2 dosages (750 versus 500 units) of the Dysport type A botulinic toxin for patient suffering from neurogenic urinary incontinence by an overactive bladder and the failure of anticholinergic drugs.

Timeline

Start: 2003-12
Primary completion: 2007-09
Completion: 2007-10

Outcome

Missed primary endpoint

Stopped: “the study has concluded normally;”

paper respectively (p=0.056; one-sided χ(2) test to compare to α=0.025). PMID 20674149 ↗

Publications

Grise P, Ruffion A, Denys P, Egon G, Chartier Kastler E. Efficacy and tolerability of botulinum toxin type A in patients with neurogenic detrusor overactivity and without concomitant anticholinergic therapy: comparison of two doses. Eur Urol. 2010 Nov;58(5):759-66. doi: 10.1016/j.eururo.2010.06.035. Epub 2010 Jul 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Type A Botulinum toxin	Unknown	500 iu	Other
Subject	Type A Botulinum toxin	Unknown	750 iu	Other