<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/NCT02230540</url>
  </required_header>
  <id_info>
    <org_study_id>CP250</org_study_id>
    <nct_id>NCT02230540</nct_id>
  </id_info>
  <brief_title>Intermittent Catheterization in Spinal Cord Injured Men</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Coloplast A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Coloplast A/S</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this investigation is to study how the position of different catheters affect&#xD;
      drainage of the bladder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual Volume Less Than 100ml</measure>
    <time_frame>2-4 hours</time_frame>
    <description>The primary endpoint was &quot;Residual volume less than 100 ml (Yes/No)&quot; assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.&#xD;
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.&#xD;
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from &quot;300ml - collected volume &lt;100ml&quot; to &quot;collected volume &gt; 200ml&quot;, were used to interpret the primary endpoint.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product A in different positions. Measurement of residual urine at different positions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequence B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Based on results from sequence A, sequence B may or may not be initiated.&#xD;
Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product B in different positions. Measurement of residual urine at different positions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SelfCath (comparator)</intervention_name>
    <description>Commercially available CE-marked catheter for urinary drainage.</description>
    <arm_group_label>Sequence A</arm_group_label>
    <arm_group_label>Sequence B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Product A SelfCath and urine bag, Conveen Security+</intervention_name>
    <description>SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).</description>
    <arm_group_label>Sequence A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Product B SelfCath and urine bag, Conveen Contour</intervention_name>
    <description>SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).</description>
    <arm_group_label>Sequence B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has given written informed consent&#xD;
&#xD;
          -  Is at least 18 years of age and has full legal capacity&#xD;
&#xD;
          -  Is a male&#xD;
&#xD;
          -  Has an Spinal Cord Injury diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participating in other interventional clinical investigations or have previously&#xD;
             participated in this investigation&#xD;
&#xD;
          -  Known hypersensitivity toward any of the test products&#xD;
&#xD;
          -  Serious abdominal scars&#xD;
&#xD;
          -  Symptoms of urinary tract infections&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Bagi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Per Bagi</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>January 18, 2016</results_first_submitted>
  <results_first_submitted_qc>January 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 15, 2016</results_first_posted>
  <last_update_submitted>February 17, 2016</last_update_submitted>
  <last_update_submitted_qc>February 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 15, 2016</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>Spinal Cord Injuries</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Sequence A</title>
          <description>Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product A in different positions. Measurement of residual urine at different positions.&#xD;
SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.&#xD;
Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).</description>
        </group>
        <group group_id="P2">
          <title>Sequence B</title>
          <description>Based on results from sequence A, sequence B may or may not be initiated.&#xD;
Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product B in different positions. Measurement of residual urine at different positions.&#xD;
SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.&#xD;
Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0">The study was terminated before initiation of sequence B. Sequence B was therefore not initiated.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Sequence A</title>
          <description>Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product A in different positions and measurement of residual urine.&#xD;
SelfCath (comparator): Catheter for urinary drainage.&#xD;
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49.5" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Residual Volume Less Than 100ml</title>
        <description>The primary endpoint was &quot;Residual volume less than 100 ml (Yes/No)&quot; assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.&#xD;
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.&#xD;
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from &quot;300ml - collected volume &lt;100ml&quot; to &quot;collected volume &gt; 200ml&quot;, were used to interpret the primary endpoint.</description>
        <time_frame>2-4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sequence A</title>
            <description>Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product A in different positions and measurement of residual urine.&#xD;
SelfCath (comparator): Catheter for urinary drainage.&#xD;
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Volume Less Than 100ml</title>
          <description>The primary endpoint was &quot;Residual volume less than 100 ml (Yes/No)&quot; assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.&#xD;
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.&#xD;
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from &quot;300ml - collected volume &lt;100ml&quot; to &quot;collected volume &gt; 200ml&quot;, were used to interpret the primary endpoint.</description>
          <units>Subjects with successful catheterization</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Height 25cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height 20cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height 15cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height 10cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Height 0cm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sequence A</title>
          <description>Catheterization with SelfCath (comparator) followed by measurement of residual urine.&#xD;
Then catheterization with Product A in different positions and measurement of residual urine.&#xD;
SelfCath (comparator): Catheter for urinary drainage.&#xD;
Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Investigators who want to publish/present results based on own data from a Coloplast-sponsored investigation, must send the publication/presentation to sponsor for review 60 days prior to submission. Sponsor reserves the right to delay publications to avoid compromising intellectual property. Publications of sub-analyses may be delayed by sponsor until main results of investigation have been published.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Per Bagi, MD</name_or_title>
      <organization>Rigshospitalet, Department of Urology</organization>
      <phone>+45 3545 8310</phone>
      <email>Per.bagi@regionh.dk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02230540
org study id: CP250
nct id: NCT02230540
lead sponsor: 
has dmc: No
The aim of this investigation is to study how the position of different catheters affect
      drainage of the bladder.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Residual Volume Less Than 100ml
time frame: 2-4 hours
description: The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume <100ml" to "collected volume > 200ml", were used to interpret the primary endpoint.
arm group label: Sequence A
arm group type: Experimental
description: Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product A in different positions. Measurement of residual urine at different positions.
arm group label: Sequence B
arm group type: Experimental
description: Based on results from sequence A, sequence B may or may not be initiated.
Catheterization with SelfCath (comparator) followed by measurement of residual urine.
Then catheterization with Product B in different positions. Measurement of residual urine at different positions.
intervention type: Device
intervention name: SelfCath (comparator)
description: Commercially available CE-marked catheter for urinary drainage.
arm group label: Sequence A
arm group label: Sequence B
intervention type: Device
intervention name: Product A SelfCath and urine bag, Conveen Security+
description: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
arm group label: Sequence A
intervention type: Device
intervention name: Product B SelfCath and urine bag, Conveen Contour
description: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
arm group label: Sequence B
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Per Bagi, MD
role: Principal Investigator
affiliation: Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 