<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01716624</url>
  </required_header>
  <id_info>
    <org_study_id>R-11-140</org_study_id>
    <secondary_id>17787</secondary_id>
    <nct_id>NCT01716624</nct_id>
  </id_info>
  <brief_title>Botox Versus Oxybutynin as First Line Treatment for the Poorly Compliant Pediatric Neurogenic Bladder</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the use of Botulinum Toxin A as primary therapy&#xD;
      for children with neurogenic bladder due to spina bifida and compare results with standard&#xD;
      oral oxybutynin therapy. This study hopes to demonstrate that Botulinum Toxin A can maintain&#xD;
      or improve bladder storage function without side effects associated with oxybutynin use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess urodynamic effects of intravesical botulinum toxin A injection to standard oral dose therapy</measure>
    <time_frame>Primary outcomes will be assessed at 3 and 6 months</time_frame>
    <description>The following urodynamic parameters will be measured;&#xD;
Change in end fill pressure or detrusor leak point pressure (cm H2O)&#xD;
Change in 20 and 30 cm H2O below volumes expressed as percentage of bladder capacity&#xD;
Change in reflex volume (percentage of bladder capacity at which neurogenic detrusor overactivity starts)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Calculate accrual rate</measure>
    <time_frame>Secondary outcomes will be assessed at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate cross over rate</measure>
    <time_frame>Secondary outcomes will be assessed at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate adverse event rates</measure>
    <time_frame>Secondary outcomes will be assessed at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare the side effects of standard oral therapy compared to Botulinum toxin A injection</measure>
    <time_frame>Secondary outcomes will be assessed at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculate drop out rate</measure>
    <time_frame>Secondary outcomes will be assessed at 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Neurogenic Bladder</condition>
  <arm_group>
    <arm_group_label>Oxybutynin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Botulinum Toxin A injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxybutynin</intervention_name>
    <description>standard oral therapy</description>
    <arm_group_label>Oxybutynin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botulinum Toxin A injection</intervention_name>
    <description>10 units/kg injected into the detrusor muscle using cystoscopy</description>
    <arm_group_label>Botulinum Toxin A injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of spina bifida and neurogenic bladder&#xD;
&#xD;
          -  Performing clean intermittent catheterization (CIC)&#xD;
&#xD;
          -  Taking 0.3-0.4 mg/kg/day of oxybutynin for a poorly compliant bladder&#xD;
&#xD;
          -  Has not had previous bladder surgery&#xD;
&#xD;
          -  Has had a urodynamic or videourodynamic study done within the last 6 months&#xD;
&#xD;
          -  Upper motor neuron (UMN) type bladder demonstrated on last urodynamic study&#xD;
&#xD;
          -  Urodynamic study (UDS) showing either detrusor leak point pressure &gt;40cm H2O; 30cm&#xD;
             below capacity &lt;60% of total bladder capacity, 20 cm capacity &lt;70% of bladder capacity&#xD;
&#xD;
          -  Able and willing to complete CIC Diaries and Quality of Life Questionnaires&#xD;
&#xD;
          -  Consent and assent given to participate in trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of lung disease, recurrent aspiration or severe neurological impairment which&#xD;
             may increase risk of Botox toxicity or anesthesia&#xD;
&#xD;
          -  Positive urine culture&#xD;
&#xD;
          -  Known allergy to Botox&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sumit Dave, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre, Laweson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre - Victoria Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>June 29, 2011</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 30, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Sumit Dave</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxybutynin</mesh_term>
    <mesh_term>Botulinum Toxins</mesh_term>
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
    <mesh_term>abobotulinumtoxinA</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716624
org study id: R-11-140
secondary id: 17787
nct id: NCT01716624
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 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
description: 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)
measure: Calculate accrual rate
time frame: Secondary outcomes will be assessed at 6 months
measure: Calculate cross over rate
time frame: Secondary outcomes will be assessed at 6 months
measure: Calculate adverse event rates
time frame: Secondary outcomes will be assessed at 6 months
measure: Compare the side effects of standard oral therapy compared to Botulinum toxin A injection
time frame: Secondary outcomes will be assessed at 6 months
measure: Calculate drop out rate
time frame: Secondary outcomes will be assessed at 6 months
arm group label: Oxybutynin
arm group type: Active Comparator
arm group label: Botulinum Toxin A injection
arm group type: Experimental
intervention type: Drug
intervention name: Oxybutynin
description: standard oral therapy
arm group label: Oxybutynin
intervention type: Drug
intervention name: Botulinum Toxin A injection
description: 10 units/kg injected into the detrusor muscle using cystoscopy
arm group label: Botulinum Toxin A injection
criteria: 
gender: All
minimum age: 5 Years
maximum age: 20 Years
healthy volunteers: No
last name: Sumit Dave, MD
role: Principal Investigator
affiliation: London Health Sciences Centre, Laweson Health Research Institute
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Sumit Dave
investigator title: Principal Investigator
mesh term: Urinary Bladder, Neurogenic
mesh term: Oxybutynin
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA