Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurogenic Bladder
Intervention: Oxybutynin (Drug); Botulinum Toxin A injection (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s):
Sumit Dave, MD, Principal Investigator, Affiliation: London Health Sciences Centre, Laweson Health Research Institute
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy
Secondary outcome: Calculate accrual rateCalculate cross over rate Calculate adverse event rates Compare the side effects of standard oral therapy compared to Botulinum toxin A injection Calculate drop out rate
Eligibility
Minimum age: 5 Years.
Maximum age: 20 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
London Health Sciences Centre - Victoria Hospital, London, Ontario N6A 5W9, Canada
Additional Information
Starting date: May 2011
Last updated: October 25, 2012
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