<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/NCT04445051</url>
  </required_header>
  <id_info>
    <org_study_id>CP322</org_study_id>
    <nct_id>NCT04445051</nct_id>
  </id_info>
  <brief_title>Investigation of New Intermittent Catheters in Healthy Volunteers</brief_title>
  <official_title>Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers</official_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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigation of non-CE marked intermittent catheters. The study was a randomized, single&#xD;
      blinded, cross-over investigation comparing two new catheters with a comparator catheter in&#xD;
      30 adult healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CP322 study investigated a novel non-CE marked intermittent catheter for males and&#xD;
      females, designed in two different variants, Variant 1 and Variant 2, respectively. The study&#xD;
      was conducted in Denmark and was a randomized, single blinded, cross-over investigation&#xD;
      comparing the two new variant catheters with a comparator catheter in 30 adult healthy&#xD;
      volunteers.&#xD;
&#xD;
      For each participant, the study thus contained three test visits/treatment arms (Comparator,&#xD;
      Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a&#xD;
      randomization sequence of six (i.e., there were six different random options for the order in&#xD;
      which the participants tested the three catheters). There were 4-14 days between the test&#xD;
      visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Residual Urine at 1st Flow-stop</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
    <description>The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-void Residual Urine</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 15 min.</time_frame>
    <description>The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheterization Insertion Discomfort</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
    <description>Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catheterization Urination Discomfort</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
    <description>Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Withdrawal Discomfort</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
    <description>Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Catheterization Discomfort</measure>
    <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
    <description>Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-catheterization Urination Discomfort</measure>
    <time_frame>Immediately after the first normal void following the procedure/catheterization, up to 5 min.</time_frame>
    <description>Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Retention, Urinary</condition>
  <arm_group>
    <arm_group_label>Intermittent catheter; SpeediCath® Standard male or female</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>New intermittent catheter Variant 1 for male or female</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>New intermittent catheter Variant 2 for male or female</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SpeediCath® Standard male or female</intervention_name>
    <description>Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.</description>
    <arm_group_label>Intermittent catheter; SpeediCath® Standard male or female</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New intermittent Variant 1 catheter for male or female</intervention_name>
    <description>Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.</description>
    <arm_group_label>New intermittent catheter Variant 1 for male or female</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New intermittent Variant 2 catheter for male or female</intervention_name>
    <description>Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.</description>
    <arm_group_label>New intermittent catheter Variant 2 for male or female</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum 18 years of age and with full legal capacity&#xD;
&#xD;
          -  Written informed consent and signed letter of authority and secrecy agreement given&#xD;
&#xD;
          -  Willing to comply with not using analgesics 1 up to 24 hours prior to catheterization&#xD;
             visits&#xD;
&#xD;
          -  Urine Multistix negative for erythrocytes (hematuria)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in any other clinical investigations during this investigation&#xD;
&#xD;
          -  Known hypersensitivity towards any of the test products&#xD;
&#xD;
          -  Symptoms of urinary tract infection (UTI) (Investigators judgement)&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Bagi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urologisk klinik, Afsnit 2112, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Copenhagen Ø</state>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <results_first_submitted>February 4, 2022</results_first_submitted>
  <results_first_submitted_qc>August 8, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2023</results_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</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 Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT04445051/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Between March 2020 and September 2020, 30 users were recruited for the study from one site (Denmark) and encompassed the safety population.</recruitment_details>
      <pre_assignment_details>The 30 recruited participant were randomized into the three treatment arms, using a randomization sequence of six. No participants were excluded, one was discontinued after Visit 2 due to an adverse event.&#xD;
Two participants total had an adverse event, both were classified as mild, non-serious, 'Possibly related' and 'Not related' (for details; see Adverse Events section).&#xD;
Thus, 30 participants constituted the intention to treat (ITT) population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Comparator, Then Variant 2, Then Variant 1</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.</description>
        </group>
        <group group_id="P2">
          <title>Variant 2, Then Variant 1, Then Comparator</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.</description>
        </group>
        <group group_id="P3">
          <title>Comparator, Then Variant 1, Then Variant 2</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Comparator. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.</description>
        </group>
        <group group_id="P4">
          <title>Variant 1, Then Comparator, Then Variant 2</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 2.</description>
        </group>
        <group group_id="P5">
          <title>Variant 1, Then Variant 2, Then Comparator</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Variant 1. Washout: 4-14 days. Second intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Third intervention: Day of catheterization with Comparator.</description>
        </group>
        <group group_id="P6">
          <title>Variant 2, Then Comparator, Then Variant 1</title>
          <description>On three separate visits and in the listed random order, the participants underwent three interventions:&#xD;
First intervention: Day of catheterization with Variant 2. Washout: 4-14 days. Second intervention: Day of catheterization with Comparator. Washout: 4-14 days. Third intervention: Day of catheterization with Variant 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Female ITT Population</title>
          <description>Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard female), the new Variant 1 female catheter, or the new Variant 2 female catheter.</description>
        </group>
        <group group_id="B2">
          <title>Male ITT Population</title>
          <description>Each treatment arm consisted of three test visits with 4-14 days between each crossover. On each visit, the participants underwent intermittent catheterization through the urethra, draining the bladder, and tested a different intermittent catheter: The comparator catheter (SpeediCath® Standard male), the new Variant 1 male catheter, or the new Variant 2 male catheter.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31" spread="12"/>
                    <measurement group_id="B2" value="32" spread="8"/>
                    <measurement group_id="B3" value="32" spread="10"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Denmark</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematuria positive</title>
          <description>Blood in the urine; dipstick analysis positive.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematuria negative</title>
          <description>Blood in the urine; dipstick analysis negative.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                    <count group_id="B2" value="15"/>
                    <count group_id="B3" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Residual Urine at 1st Flow-stop</title>
        <description>The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Residual Urine at 1st Flow-stop</title>
          <description>The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0" spread="71.0"/>
                    <measurement group_id="O2" value="1.1" spread="2.6"/>
                    <measurement group_id="O3" value="0.2" spread="0.7"/>
                    <measurement group_id="O4" value="37.0" spread="40.0"/>
                    <measurement group_id="O5" value="2.2" spread="6.2"/>
                    <measurement group_id="O6" value="1.0" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>32.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.3</ci_lower_limit>
            <ci_upper_limit>57.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.007</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>34.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.8</ci_lower_limit>
            <ci_upper_limit>58.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.908</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.1</ci_lower_limit>
            <ci_upper_limit>25.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>35.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>10.8</ci_lower_limit>
            <ci_upper_limit>59.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>36.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.9</ci_lower_limit>
            <ci_upper_limit>61.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.899</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.3</ci_lower_limit>
            <ci_upper_limit>26.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-void Residual Urine</title>
        <description>The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 15 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-void Residual Urine</title>
          <description>The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="11.4"/>
                    <measurement group_id="O2" value="1.5" spread="6.1"/>
                    <measurement group_id="O3" value="27.6" spread="104.1"/>
                    <measurement group_id="O4" value="5.3" spread="8.9"/>
                    <measurement group_id="O5" value="24.3" spread="79.1"/>
                    <measurement group_id="O6" value="16.3" spread="31.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.665</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>8.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.9</ci_lower_limit>
            <ci_upper_limit>49.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.375</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-58.7</ci_lower_limit>
            <ci_upper_limit>22.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.188</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-27.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-67.6</ci_lower_limit>
            <ci_upper_limit>13.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.361</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-18.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-59.3</ci_lower_limit>
            <ci_upper_limit>21.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.600</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-10.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-52.3</ci_lower_limit>
            <ci_upper_limit>30.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.707</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>7.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-33.5</ci_lower_limit>
            <ci_upper_limit>49.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Catheterization Insertion Discomfort</title>
        <description>Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Catheterization Insertion Discomfort</title>
          <description>Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.51" spread="0.72"/>
                    <measurement group_id="O2" value="0.81" spread="0.96"/>
                    <measurement group_id="O3" value="0.86" spread="1.15"/>
                    <measurement group_id="O4" value="2.32" spread="2.24"/>
                    <measurement group_id="O5" value="2.31" spread="1.97"/>
                    <measurement group_id="O6" value="2.79" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.615</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.08</ci_lower_limit>
            <ci_upper_limit>0.65</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.480</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.17</ci_lower_limit>
            <ci_upper_limit>0.56</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.839</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.95</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.894</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.92</ci_lower_limit>
            <ci_upper_limit>0.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.195</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>0.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.242</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.52</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.40</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Catheterization Urination Discomfort</title>
        <description>Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Catheterization Urination Discomfort</title>
          <description>Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.18" spread="0.23"/>
                    <measurement group_id="O2" value="0.47" spread="0.83"/>
                    <measurement group_id="O3" value="0.55" spread="0.93"/>
                    <measurement group_id="O4" value="0.93" spread="1.62"/>
                    <measurement group_id="O5" value="0.74" spread="0.86"/>
                    <measurement group_id="O6" value="1.51" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.639</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.20</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.492</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.33</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.30</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.828</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.07</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.744</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.81</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.208</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.62</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.116</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.79</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.77</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Withdrawal Discomfort</title>
        <description>Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Withdrawal Discomfort</title>
          <description>Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" spread="0.70"/>
                    <measurement group_id="O2" value="0.83" spread="0.94"/>
                    <measurement group_id="O3" value="1.11" spread="1.32"/>
                    <measurement group_id="O4" value="2.05" spread="2.55"/>
                    <measurement group_id="O5" value="1.42" spread="1.86"/>
                    <measurement group_id="O6" value="2.28" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.798</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.11</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.75</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.556</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.10</ci_lower_limit>
            <ci_upper_limit>0.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.399</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.36</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>0.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.198</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.30</ci_lower_limit>
            <ci_upper_limit>1.41</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.365</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.40</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>0.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.033</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.82</ci_lower_limit>
            <ci_upper_limit>-0.08</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Catheterization Discomfort</title>
        <description>Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
        <time_frame>Immediately after the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Catheterization Discomfort</title>
          <description>Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.66" spread="0.65"/>
                    <measurement group_id="O2" value="0.72" spread="0.63"/>
                    <measurement group_id="O3" value="1.04" spread="1.63"/>
                    <measurement group_id="O4" value="1.99" spread="2.19"/>
                    <measurement group_id="O5" value="1.71" spread="1.57"/>
                    <measurement group_id="O6" value="2.58" spread="2.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.882</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.478</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.21</ci_lower_limit>
            <ci_upper_limit>0.57</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.391</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.27</ci_lower_limit>
            <ci_upper_limit>0.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.657</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.69</ci_lower_limit>
            <ci_upper_limit>1.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.125</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.62</ci_lower_limit>
            <ci_upper_limit>0.20</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.051</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.81</ci_lower_limit>
            <ci_upper_limit>0.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-catheterization Urination Discomfort</title>
        <description>Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
        <time_frame>Immediately after the first normal void following the procedure/catheterization, up to 5 min.</time_frame>
        <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
        <group_list>
          <group group_id="O1">
            <title>Intermittent Catheter; SpeediCath® Standard Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O2">
            <title>New Intermittent Catheter Variant 1 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O3">
            <title>New Intermittent Catheter Variant 2 for Female</title>
            <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O4">
            <title>Intermittent Catheter; SpeediCath® Standard Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O5">
            <title>New Intermittent Catheter Variant 1 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
          <group group_id="O6">
            <title>New Intermittent Catheter Variant 2 for Male</title>
            <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-catheterization Urination Discomfort</title>
          <description>Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.</description>
          <population>The intention to treat population (full analysis set) constituted all randomized subjects with a valid informed consent who was exposed to at least one product, and with valid information on at least one product with respect to the endpoints.</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.29" spread="0.63"/>
                    <measurement group_id="O2" value="0.09" spread="0.16"/>
                    <measurement group_id="O3" value="0.35" spread="0.72"/>
                    <measurement group_id="O4" value="0.66" spread="1.56"/>
                    <measurement group_id="O5" value="0.66" spread="0.84"/>
                    <measurement group_id="O6" value="1.88" spread="2.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.877</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.83</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.351</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.42</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.31</ci_lower_limit>
            <ci_upper_limit>0.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.278</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.38</ci_lower_limit>
            <ci_upper_limit>0.40</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O5</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.711</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.73</ci_lower_limit>
            <ci_upper_limit>1.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O4</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.024</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.97</ci_lower_limit>
            <ci_upper_limit>-0.15</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O5</group_id>
              <group_id>O6</group_id>
            </group_id_list>
            <groups_desc>Due to the exploratory nature of this investigation, no formal pass/fail criteria were applied.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>The P-values were not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Random effect: Subject. Fixed effects: Visit (Visit 1, 2 and 3), Treatment (comparator, Variant 1 and Variant 2)*Gender (male and females)</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.23</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.14</ci_lower_limit>
            <ci_upper_limit>-0.31</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each participant was enrolled for 3 x 4-14 days for the entire investigation, thus a maximum of 42 days.</time_frame>
      <desc>The relationship to the investigational or comparator products was collected. The safety population constituted the subjects who had given informed consent and were thus 30 participants.&#xD;
An adverse event was reported as either: &quot;Not related&quot;, &quot;Unlikely related&quot;, &quot;Possibly related&quot;, &quot;Probably related&quot;, or &quot;Definitely related&quot;, to the comparator to the Variant 1 or Variant 2 products.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intermittent Catheter; SpeediCath® Standard Female</title>
          <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard female (active comparator). The catheterizations were performed by a trained nurses.</description>
        </group>
        <group group_id="E2">
          <title>New Intermittent Catheter Variant 1 for Female</title>
          <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for females. The catheterizations were performed by a trained nurses.</description>
        </group>
        <group group_id="E3">
          <title>New Intermittent Catheter Variant 2 for Female</title>
          <description>Female participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for females. The catheterizations were performed by a trained nurses.</description>
        </group>
        <group group_id="E4">
          <title>Intermittent Catheter; SpeediCath® Standard Male</title>
          <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with standard of care intermittent catheter; SpeediCath® Standard male (active comparator). The catheterizations were performed by a trained nurses.</description>
        </group>
        <group group_id="E5">
          <title>New Intermittent Catheter Variant 1 for Male</title>
          <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 1 for males. The catheterizations were performed by a trained nurses.</description>
        </group>
        <group group_id="E6">
          <title>New Intermittent Catheter Variant 2 for Male</title>
          <description>Male participants underwent intermittent catheterization through the urethra, draining the bladder. Catheterization was performed with new intermittent catheter Variant 2 for males. The catheterizations were performed by a trained nurses.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <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="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Possibly related</sub_title>
                <description>Urinary tract infection (UTI)</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Vice President, Medical Affairs</name_or_title>
      <organization>Coloplast A/S</organization>
      <phone>+4549111111</phone>
      <email>clinical-studies@coloplast.com</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/NCT04445051
org study id: CP322
nct id: NCT04445051
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigation of non-CE marked intermittent catheters. The study was a randomized, single
      blinded, cross-over investigation comparing two new catheters with a comparator catheter in
      30 adult healthy volunteers.
The CP322 study investigated a novel non-CE marked intermittent catheter for males and
      females, designed in two different variants, Variant 1 and Variant 2, respectively. The study
      was conducted in Denmark and was a randomized, single blinded, cross-over investigation
      comparing the two new variant catheters with a comparator catheter in 30 adult healthy
      volunteers.

      For each participant, the study thus contained three test visits/treatment arms (Comparator,
      Variant 1 and Variant 2, respectively), to which the 30 participants were randomized using a
      randomization sequence of six (i.e., there were six different random options for the order in
      which the participants tested the three catheters). There were 4-14 days between the test
      visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Residual Urine at 1st Flow-stop
time frame: Immediately after the procedure/catheterization, up to 5 min.
description: The residual urine at 1st flow-stop during catheterization (performed by a nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.
measure: Post-void Residual Urine
time frame: Immediately after the procedure/catheterization, up to 15 min.
description: The volume of residual urine (urine left in the bladder) post catheterization (performed by the nurse) measured in triplicates using an ultrasound scanner.
measure: Catheterization Insertion Discomfort
time frame: Immediately after the procedure/catheterization, up to 5 min.
description: Discomfort measured at catheter insertion, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
measure: Catheterization Urination Discomfort
time frame: Immediately after the procedure/catheterization, up to 5 min.
description: Discomfort measured during catheter emptying/urination, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
measure: Withdrawal Discomfort
time frame: Immediately after the procedure/catheterization, up to 5 min.
description: Discomfort measured during catheter withdrawal, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
measure: Overall Catheterization Discomfort
time frame: Immediately after the procedure/catheterization, up to 5 min.
description: Discomfort measured for the overall/entire catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
measure: Post-catheterization Urination Discomfort
time frame: Immediately after the first normal void following the procedure/catheterization, up to 5 min.
description: Discomfort measured for the first normal void/urination after the catheterization procedure, using the Visual Analogue Scale (VAS). The VAS is a tool used to rate the intensity of certain sensations and feelings, e.g. discomfort/pain. It is a straight line of 10 cm (in this case horizontal) with one end meaning no discomfort/pain (0 cm) and the other end meaning the worst discomfort/pain imaginable (10 cm). The subject visualizes and marks a point on the line that matches the amount of discomfort/pain experienced. A high score reflects a worse outcome than a lower score.
arm group label: Intermittent catheter; SpeediCath® Standard male or female
arm group type: Active Comparator
description: Participants underwent catheterization with standard of care intermittent catheter. The catheterization was performed by a trained nurse.
arm group label: New intermittent catheter Variant 1 for male or female
arm group type: Experimental
description: Participants underwent catheterization with the new intermittent catheter Variant 1 for males or females. The catheterization was performed by a trained nurse.
arm group label: New intermittent catheter Variant 2 for male or female
arm group type: Experimental
description: Participants underwent catheterization with the new intermittent catheter Variant 2 for males or females. The catheterization was performed by a trained nurse.
intervention type: Device
intervention name: SpeediCath® Standard male or female
description: Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male or female.
arm group label: Intermittent catheter; SpeediCath® Standard male or female
intervention type: Device
intervention name: New intermittent Variant 1 catheter for male or female
description: Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 for male or female.
arm group label: New intermittent catheter Variant 1 for male or female
intervention type: Device
intervention name: New intermittent Variant 2 catheter for male or female
description: Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 for male or female.
arm group label: New intermittent catheter Variant 2 for male or female
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Per Bagi, MD
role: Principal Investigator
affiliation: Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Urinary Retention
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 