drugset / Trial / NCT01716624
Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Phase 3
Completed
20 enrolled
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy for children with neurogenic bladder due to spina bifida and compare results with standard oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain or improve bladder storage function without side effects associated with oxybutynin use.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-03
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 10 iu/kg | Other |
| Comparator | Oxybutynin | Small molecule | — | Oral |