<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/NCT03043287</url>
  </required_header>
  <id_info>
    <org_study_id>CMO-US-URO-0506</org_study_id>
    <nct_id>NCT03043287</nct_id>
  </id_info>
  <brief_title>Voiding Efficiency, a Predictor of Clean Intermittent Catheterization (CIC)</brief_title>
  <official_title>Voiding Efficiency, a Predictor of CIC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allergan</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allergan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a retrospective chart review of patients treated with onabotulinumtoxinA&#xD;
      (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE)&#xD;
      cutoff ratios that predict post-procedure urinary retention requiring catheterization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®</measure>
    <time_frame>Pre-BOTOX® Injection (Baseline)</time_frame>
    <description>VE was calculated as the ratio of voided volume to the total bladder capacity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®</measure>
    <time_frame>12 Weeks</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">420</enrollment>
  <condition>Urinary Bladder, Overactive</condition>
  <arm_group>
    <arm_group_label>BOTOX®</arm_group_label>
    <description>Participants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is administered in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>onabotulinumtoxinA</intervention_name>
    <description>onabotulinumtoxinA (BOTOX®)100 to 200 U</description>
    <arm_group_label>BOTOX®</arm_group_label>
    <other_name>Botulinum Toxin Type A</other_name>
    <other_name>BOTOX®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with BOTOX® for Idiopathic OAB in clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with documented idiopathic OAB diagnosis&#xD;
&#xD;
          -  Patient was treated with 100-200U of BOTOX® for OAB&#xD;
&#xD;
          -  Urodynamics assessment within prior to first BOTOX® injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient had received botulinum toxin formulations other than BOTOX® in the bladder&#xD;
&#xD;
          -  Patient had symptoms of OAB associated with a neurological condition (eg, spinal cord&#xD;
             injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's&#xD;
             disease, etc).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana Fetterolf</last_name>
    <role>Study Director</role>
    <affiliation>Allergan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Urology</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chesapeake Urology Associates, LLC</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Urology</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.allerganclinicaltrials.com</url>
    <description>More Information</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03043287
org study id: CMO-US-URO-0506
nct id: NCT03043287
lead sponsor: 
has dmc: No
This study is a retrospective chart review of patients treated with onabotulinumtoxinA
      (BOTOX®) for idiopathic overactive bladder (OAB) and will determine voiding efficiency (VE)
      cutoff ratios that predict post-procedure urinary retention requiring catheterization.
observational model: Case-Only
time perspective: Retrospective
measure: Pre-BOTOX® Injection VE Cutoff-Ratios that Predict the Risk of CIC following Treatment with 100-200U of BOTOX®
time frame: Pre-BOTOX® Injection (Baseline)
description: VE was calculated as the ratio of voided volume to the total bladder capacity.
measure: Length of Time of CIC Use in Clinical Practice after Treatment with 100-200U BOTOX®
time frame: 12 Weeks
arm group label: BOTOX®
description: Participants who received 100 to 200 units (U) onabotulinumtoxinA (BOTOX®) as treatment for OAB. No study drug is administered in this study.
intervention type: Biological
intervention name: onabotulinumtoxinA
description: onabotulinumtoxinA (BOTOX®)100 to 200 U
arm group label: BOTOX®
other name: Botulinum Toxin Type A
other name: BOTOX®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dana Fetterolf
role: Study Director
affiliation: Allergan
facility: 
facility: 
facility: 
country: United States
url: http://www.allerganclinicaltrials.com
description: More Information
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
mesh term: Botulinum Toxins
mesh term: Botulinum Toxins, Type A
mesh term: abobotulinumtoxinA