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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Neurogenic Bladder

Intervention / Treatment
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* Drug: Oxybutynin
* Drug: Botulinum Toxin A injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxybutynin<br> | Drug: Oxybutynin<br>* standard oral therapy<br>|
| Experimental: Botulinum Toxin A injection<br> | Drug: Botulinum Toxin A injection<br>* 10 units/kg injected into the detrusor muscle using cystoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy | The following urodynamic parameters will be measured; Change in end fill pressure or detrusor leak point pressure (cm H2O) Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts) | Primary outcomes will be assessed at 3 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric