NCT01716624

Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

A Pilot Study Comparing the Effects of Botulinum Toxin A and Standard Oxybutynin Therapy as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 5 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Bladder

Interventions

Type	Name	Description
DRUG	Oxybutynin	standard oral therapy
DRUG	Botulinum Toxin A injection	10 units/kg injected into the detrusor muscle using cystoscopy

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2012-10-30
• Last updated: 2012-10-30

Locations

1 site across 1 country: Canada