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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


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 rate

Calculate 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


Minimum age: 5 Years. Maximum age: 20 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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