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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01716624
Recruitment Status : Completed
First Posted : October 30, 2012
Last Update Posted : October 30, 2012
Information provided by (Responsible Party):
Sumit Dave, 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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Drug: Oxybutynin Drug: Botulinum Toxin A injection Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

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

Primary Outcome Measures :
  1. 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 ]

    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 :
  1. Calculate accrual rate [ Time Frame: Secondary outcomes will be assessed at 6 months ]
  2. Calculate cross over rate [ Time Frame: Secondary outcomes will be assessed at 6 months ]
  3. Calculate adverse event rates [ Time Frame: Secondary outcomes will be assessed at 6 months ]
  4. Compare the side effects of standard oral therapy compared to Botulinum toxin A injection [ Time Frame: Secondary outcomes will be assessed at 6 months ]
  5. Calculate drop out rate [ Time Frame: Secondary outcomes will be assessed at 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01716624

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Canada, Ontario
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Sumit Dave, MD London Health Sciences Centre, Laweson Health Research Institute
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Responsible Party: Sumit Dave, Principal Investigator, Lawson Health Research Institute Identifier: NCT01716624    
Other Study ID Numbers: R-11-140
17787 ( Other Identifier: REB )
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: October 2012
Keywords provided by Sumit Dave, Lawson Health Research Institute:
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Urological Agents