<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/NCT03801720</url>
  </required_header>
  <id_info>
    <org_study_id>1190457</org_study_id>
    <nct_id>NCT03801720</nct_id>
  </id_info>
  <brief_title>UltraWee: Ultrasound Bladder Stimulation</brief_title>
  <official_title>UltraWee: Ultrasound Bladder Stimulation to Help With Clean Catch Urine in Pre-Continent Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York - Upstate Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York - Upstate Medical University</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 UltraWee study is a prospective randomized controlled trial used to compare the success&#xD;
      rate of and time to obtaining a urine sample in pre-continent children between standard clean&#xD;
      catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives&#xD;
      of this study are to see if ultrasound stimulation increases success rate of micturition,&#xD;
      decreases time to micturition, and decreases the use of more invasive techniques for urine&#xD;
      collection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard procedure for obtaining urine samples in the pediatrics emergency department&#xD;
      consists of a clean catch urine (CCU). For those patients who are still pre-continent, this&#xD;
      involves cleaning the genitourinary (GU) area with betadine followed with waiting with a&#xD;
      specimen cup for the patient to produce urine.&#xD;
&#xD;
      Currently, the CCU technique has had mixed success rates of micturition, some studies showing&#xD;
      as low as 12% success rate. Because of the mixed success rates, often times these patients&#xD;
      are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs&#xD;
      in patients with clinical conditions that require urine samples under time sensitive&#xD;
      conditions.&#xD;
&#xD;
      Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a&#xD;
      novel study that showed a promising alternative to obtaining urine samples in pre-continent&#xD;
      children when compared to the CCU sample. This method served as a noninvasive way to obtain a&#xD;
      urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and&#xD;
      improving parent satisfaction scores.&#xD;
&#xD;
      The investigators hope to study the effectiveness of another technique for obtaining a urine&#xD;
      sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound&#xD;
      evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts&#xD;
      at obtaining a urine sample in pre-continent children less than thirty-six months of age.&#xD;
&#xD;
      The UltraWee study will be a prospective randomized controlled trial comparing success rate&#xD;
      of and time to obtaining a urine sample in pre-continent children between standard clean&#xD;
      catch urine method and using ultrasound stimulation clean catch methods. The objective of&#xD;
      this study is to see if ultrasound stimulation increases success rate and decreases time to&#xD;
      micturition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of miturition</measure>
    <time_frame>Less than 5 minutes</time_frame>
    <description>Recorded act of successfully initiating miturition/urination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Miturition</measure>
    <time_frame>0-5 minutes</time_frame>
    <description>Recorded time to miturition</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">354</enrollment>
  <condition>Urinalysis</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Utilize standard practice for obtaining a CCU in pre-continent children; this consists of cleaning the GU area with betadine and waiting 5 minutes for micturition to occur.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consists of cleaning the GU area with betadine followed by using an ultrasound probe to apply cool ultrasound gel and subprapubic pressure to the patient to induce micturition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Using ultrasound stimulation to induce micturition.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pre-continent children&#xD;
&#xD;
          -  Children between the ages of 1 month and 36 months&#xD;
&#xD;
          -  Children who require a urine sample as part of their workup&#xD;
&#xD;
          -  Children who are seen in the emergency department at University Hospital Downtown&#xD;
             Campus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who are continent&#xD;
&#xD;
          -  Children who are in foster care or who are wards of the state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vincent Calleo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State University of New York - Upstate Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York - Upstate Medical University</investigator_affiliation>
    <investigator_full_name>Vincent Calleo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Clean Catch Urine (CCU)</keyword>
  <keyword>Catherterization</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>Micturition</keyword>
  <keyword>Urine Collection</keyword>
  <keyword>Pre-Continent Children</keyword>
  <keyword>Pediatrics</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03801720
org study id: 1190457
nct id: NCT03801720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The UltraWee study is a prospective randomized controlled trial used to compare the success
      rate of and time to obtaining a urine sample in pre-continent children between standard clean
      catch urine (CCU) method and using ultrasound stimulation clean catch methods. The objectives
      of this study are to see if ultrasound stimulation increases success rate of micturition,
      decreases time to micturition, and decreases the use of more invasive techniques for urine
      collection.
Standard procedure for obtaining urine samples in the pediatrics emergency department
      consists of a clean catch urine (CCU). For those patients who are still pre-continent, this
      involves cleaning the genitourinary (GU) area with betadine followed with waiting with a
      specimen cup for the patient to produce urine.

      Currently, the CCU technique has had mixed success rates of micturition, some studies showing
      as low as 12% success rate. Because of the mixed success rates, often times these patients
      are subjected to the discomfort and trauma of a urinary catheter. Catheterization also occurs
      in patients with clinical conditions that require urine samples under time sensitive
      conditions.

      Less invasive ways of urine collections have been recently studied. The Quick-Wee study was a
      novel study that showed a promising alternative to obtaining urine samples in pre-continent
      children when compared to the CCU sample. This method served as a noninvasive way to obtain a
      urine sample, thus preventing uncomfortable and traumatic urinary catheterizations and
      improving parent satisfaction scores.

      The investigators hope to study the effectiveness of another technique for obtaining a urine
      sample without urinary catheterization: ultrasound stimulation. By incorporating ultrasound
      evaluation of the bladder, the UltraWee study hopes to decrease the number of failed attempts
      at obtaining a urine sample in pre-continent children less than thirty-six months of age.

      The UltraWee study will be a prospective randomized controlled trial comparing success rate
      of and time to obtaining a urine sample in pre-continent children between standard clean
      catch urine method and using ultrasound stimulation clean catch methods. The objective of
      this study is to see if ultrasound stimulation increases success rate and decreases time to
      micturition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Incidence of miturition
time frame: Less than 5 minutes
description: Recorded act of successfully initiating miturition/urination
measure: Time to Miturition
time frame: 0-5 minutes
description: Recorded time to miturition
arm group label: Control Group
arm group type: No Intervention
description: Utilize standard practice for obtaining a CCU in pre-continent children; this consists of cleaning the GU area with betadine and waiting 5 minutes for micturition to occur.
arm group label: Experimental Group
arm group type: Experimental
description: Consists of cleaning the GU area with betadine followed by using an ultrasound probe to apply cool ultrasound gel and subprapubic pressure to the patient to induce micturition.
intervention type: Other
intervention name: Ultrasound
description: Using ultrasound stimulation to induce micturition.
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 36 Months
healthy volunteers: No
last name: Vincent Calleo, MD
role: Principal Investigator
affiliation: State University of New York - Upstate Medical University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York - Upstate Medical University
investigator full name: Vincent Calleo
investigator title: Principal Investigator
sharing ipd: No