Neurogenic Bladder
Conditions
Keywords
Pediatric
Brief 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.
Interventions
DRUGOxybutynin
standard oral therapy
10 units/kg injected into the detrusor muscle using cystoscopy
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of spina bifida and neurogenic bladder * Performing clean intermittent catheterization (CIC) * Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder * Has not had previous bladder surgery * Has had a urodynamic or videourodynamic study done within the last 6 months * Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study * Urodynamic study (UDS) showing either detrusor leak point pressure \>40cm H2O; 30cm below capacity \<60% of total bladder capacity, 20 cm capacity \<70% of bladder capacity * Able and willing to complete CIC Diaries and Quality of Life Questionnaires * Consent and assent given to participate in trial
Exclusion criteria
* History of lung disease, recurrent aspiration or severe neurological impairment which may increase risk of Botox toxicity or anesthesia * Positive urine culture * Known allergy to Botox
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy | Primary outcomes will be assessed at 3 and 6 months | 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) |
Secondary
| Measure | Time frame |
|---|---|
| Calculate accrual rate | Secondary outcomes will be assessed at 6 months |
| Calculate cross over rate | Secondary outcomes will be assessed at 6 months |
| Calculate adverse event rates | Secondary outcomes will be assessed at 6 months |
| Compare the side effects of standard oral therapy compared to Botulinum toxin A injection | Secondary outcomes will be assessed at 6 months |
| Calculate drop out rate | Secondary outcomes will be assessed at 6 months |
Countries
Canada
Outcome results
None listed