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

Phase 3

Completed

• Conditions: Neurogenic Bladder
• Interventions: Drug: Botulinum Toxin A injection; Drug: Oxybutynin

• Registration Number: NCT01716624
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-29
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Status Verified: 2012-10
• Study First Submitted QC: 2012-10-25
• Last Update Submitted: 2012-10-25
• Study First Posted: 2012-10-30
• Last Update Posted: 2012-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin A injection	Botulinum Toxin A injection	-
Oxybutynin	Oxybutynin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Calculate accrual rate	Secondary outcomes will be assessed at 6 months
Calculate cross over rate	Secondary outcomes will be assessed at 6 months
Calculate drop out 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

Trial Locations

Locations (1)

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada