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

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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder
• Intervention / Treatment: Drug: Oxybutynin; Drug: Botulinum Toxin A injection

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre - Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Oxybutynin	Drug: Oxybutynin; standard oral therapy
EXPERIMENTAL: Botulinum Toxin A injection	Drug: Botulinum Toxin A injection; 10 units/kg injected into the detrusor muscle using cystoscopy

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Sumit Dave, MD, London Health Sciences Centre, Laweson Health Research Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): March 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (ESTIMATE): October 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Pediatric
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Oxybutynin; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: R-11-140; 17787 (REB)