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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sumit Dave, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01716624
First received: June 29, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Neurogenic Bladder
 Drug: Oxybutynin
Drug: Botulinum Toxin A injection
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy [ Time Frame: Primary outcomes will be assessed at 3 and 6 months ] [ Designated as safety issue: No ]

    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:
  • Calculate accrual rate [ Time Frame: Secondary outcomes will be assessed at 6 months ] [ Designated as safety issue: No ]
  • Calculate cross over rate [ Time Frame: Secondary outcomes will be assessed at 6 months ] [ Designated as safety issue: No ]
  • Calculate adverse event rates [ Time Frame: Secondary outcomes will be assessed at 6 months ] [ Designated as safety issue: No ]
  • Compare the side effects of standard oral therapy compared to Botulinum toxin A injection [ Time Frame: Secondary outcomes will be assessed at 6 months ] [ Designated as safety issue: No ]
  • Calculate drop out rate [ Time Frame: Secondary outcomes will be assessed at 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2011
Study Completion Date: April 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716624

Locations
Canada, Ontario
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Sumit Dave, MD London Health Sciences Centre, Laweson Health Research Institute
  More Information

No publications provided

Responsible Party: Sumit Dave, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01716624     History of Changes
Other Study ID Numbers: R-11-140, 17787
Study First Received: June 29, 2011
Last Updated: October 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Pediatric

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Botulinum Toxins, Type A
Oxybutynin
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013