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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
standard oral therapy
10 units/kg injected into the detrusor muscle using cystoscopy
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
The following urodynamic parameters will be measured; 1. Change in end fill pressure or detrusor leak point pressure (cm H2O) 2. Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity 3. Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)
Time frame: Primary outcomes will be assessed at 3 and 6 months
Calculate accrual rate
Time frame: Secondary outcomes will be assessed at 6 months
Calculate cross over rate
Time frame: Secondary outcomes will be assessed at 6 months
Calculate adverse event rates
Time frame: Secondary outcomes will be assessed at 6 months
Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
Time frame: Secondary outcomes will be assessed at 6 months
Calculate drop out rate
Time frame: Secondary outcomes will be assessed at 6 months
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