<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/NCT03785262</url>
  </required_header>
  <id_info>
    <org_study_id>113221</org_study_id>
    <nct_id>NCT03785262</nct_id>
  </id_info>
  <brief_title>Low Energy Surface Waves for Neurogenic Bladder Patients With Indwelling Catheters</brief_title>
  <official_title>Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Uroshield device is a commercially available device with two parts: a disposable actuator&#xD;
      which attaches to the external portion of the catheter and a portable battery. The device&#xD;
      sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These&#xD;
      acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of&#xD;
      biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can&#xD;
      reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an&#xD;
      indwelling catheter, as well as improve urinary quality of life and symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacteriuria</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion with bacteriuria &gt;10^5 cfu at day 30</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurogenic bladder symptom score (NBSS)</measure>
    <time_frame>30 days</time_frame>
    <description>Validated symptom score that measures symptoms related to neurogenic bladder dysfunction and urinary quality of life. Total scale ranges from 0-74, and a lower number is considered a better outcome and represents lower symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient subjective rating of amount of sediment/debris at the end of the 30 days</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total bacterial cell counts</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiome comparison of biofilms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scanning electron microscopy of biofilms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Neurogenic Bladder</condition>
  <condition>Urinary Tract Infections</condition>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Inactive uroshield device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Uroshield</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active uroshield device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Uroshield</intervention_name>
    <description>The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.</description>
    <arm_group_label>Active Uroshield</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Uroshield</intervention_name>
    <description>The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt;18 years of age&#xD;
&#xD;
          2. Spinal cord injury (&gt;1 year), multiple sclerosis (&gt;1 year), spina bifida, parkinsons&#xD;
             (&gt;1 year)&#xD;
&#xD;
          3. Indwelling catheter (urethral or suprapubic) for &gt;3 months, and used as primary&#xD;
             bladder management mechanism&#xD;
&#xD;
          4. &gt;1 urinary tract infection in the last 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Intravesical botox in the last 6 months&#xD;
&#xD;
          2. Chronic antibiotic suppressive therapy&#xD;
&#xD;
          3. Active symptomatic UTI on day of randomization&#xD;
&#xD;
          4. Unable to understand written and spoken English&#xD;
&#xD;
          5. Prior/current utilization of the Uroshield device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St Josephs Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 12, 2022</last_update_submitted>
  <last_update_submitted_qc>December 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</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>Infections</mesh_term>
    <mesh_term>Urinary Tract Infections</mesh_term>
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </patient_data>
  <!-- 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/NCT03785262
org study id: 113221
nct id: NCT03785262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Uroshield device is a commercially available device with two parts: a disposable actuator
      which attaches to the external portion of the catheter and a portable battery. The device
      sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These
      acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of
      biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can
      reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an
      indwelling catheter, as well as improve urinary quality of life and symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bacteriuria
time frame: 30 days
description: Proportion with bacteriuria >10^5 cfu at day 30
measure: Neurogenic bladder symptom score (NBSS)
time frame: 30 days
description: Validated symptom score that measures symptoms related to neurogenic bladder dysfunction and urinary quality of life. Total scale ranges from 0-74, and a lower number is considered a better outcome and represents lower symptom burden.
measure: Patient subjective rating of amount of sediment/debris at the end of the 30 days
time frame: 30 days
measure: Total bacterial cell counts
time frame: 30 days
measure: Microbiome comparison of biofilms
time frame: 30 days
measure: Scanning electron microscopy of biofilms
time frame: 30 days
arm group label: Sham
arm group type: Sham Comparator
description: Inactive uroshield device
arm group label: Active Uroshield
arm group type: Experimental
description: Active uroshield device
intervention type: Device
intervention name: Uroshield
description: The Uroshield device sends out low-frequency ultrasound waves which run along the surface of the catheter.
arm group label: Active Uroshield
intervention type: Device
intervention name: Sham Uroshield
description: The sham Uroshield device is identical to the active machine, but it does not send out low-frequency ultrasound waves along the surface of the catheter.
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infections
mesh term: Urinary Tract Infections
mesh term: Urinary Bladder, Neurogenic
sharing ipd: No
ipd description: No plan