<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/NCT02989545</url>
  </required_header>
  <id_info>
    <org_study_id>Shaare Zedek Medical Center FI</org_study_id>
    <nct_id>NCT02989545</nct_id>
  </id_info>
  <brief_title>The Use of an &quot;Anal-Tape&quot; in Patients With Fecal Incontinence</brief_title>
  <official_title>The Use of an &quot;Anal-Tape&quot; in Patients With Fecal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shaare Zedek Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months&#xD;
      and is a devastating disease. The negative impact on quality of life has been consistently&#xD;
      demonstrated. The prevalence of FI is probably underestimated in most studies. Currently&#xD;
      conservative treatment is only modestly effective and surgical treatment is complex and&#xD;
      expensive with less than optimal efficacy.&#xD;
&#xD;
      The investigators developed an &quot;anal tape&quot; using a commercially available elastic band with a&#xD;
      special adhesive that is approved for use in the skin. A special design of the tape can be&#xD;
      applied to the skin surrounding the anus providing support and additional pressure forces to&#xD;
      the anal sphincter.&#xD;
&#xD;
      This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and&#xD;
      safety of this device in patients with FI. The primary endpoint will be improvement in&#xD;
      quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)</measure>
    <time_frame>2 weeks</time_frame>
    <description>The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 &quot;excellent&quot; to 5 &quot;poor&quot; and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 &quot;extremely so&quot; to 6 &quot;not at all.&quot; The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A 50% Reduction in the Number of Episodes of FI Per Week</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Wexner Score</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Redction in Wexner Scale Compared to Baseline</measure>
    <time_frame>2 weeks</time_frame>
    <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Satisfaction</measure>
    <time_frame>2 weeks</time_frame>
    <description>General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness of the Patient to Continue Using the Anal Tape After the Study.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Off treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>2 week period without intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment period</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 week period with intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anal Tape</intervention_name>
    <arm_group_label>Treatment period</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  Fecal incontinence for more than 6 months&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Understand the study procedures&#xD;
&#xD;
          -  Is able to apply and remove the &quot;anal tape&quot; without significant assistance of others.&#xD;
&#xD;
          -  Have done sigmoidsocopy or colonoscopy and anal manometry within five year of&#xD;
             screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Advanced full thickness rectal prolapse.&#xD;
&#xD;
          -  Injured, inflamed or any significant disease in the peri-anal skin.&#xD;
&#xD;
          -  Allergy to any component of the device, either known or developed during testing in&#xD;
             the screening visit.&#xD;
&#xD;
          -  Moderate to severe proctitis of any etiology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>December 3, 2019</results_first_submitted>
  <results_first_submitted_qc>April 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 2, 2020</results_first_posted>
  <last_update_submitted>April 1, 2020</last_update_submitted>
  <last_update_submitted_qc>April 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shaare Zedek Medical Center</investigator_affiliation>
    <investigator_full_name>Dan Livovsky</investigator_full_name>
    <investigator_title>Dr. Dan M. Livovsky and Dr. Joseph Lysy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</mesh_term>
  </condition_browse>
  <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>December 25, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT02989545/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Per Sequence</title>
          <description>Off treatment first for 14 days Treatment period second for 14 days</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Control Period - no Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment Period - Anal Tape Provided</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Patients</title>
          <description>2 week period without intervention then 2 week period with anal tape intervention</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" lower_limit="56.5" upper_limit="69.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)</title>
        <description>The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 &quot;excellent&quot; to 5 &quot;poor&quot; and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 &quot;extremely so&quot; to 6 &quot;not at all.&quot; The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off Treatment</title>
            <description>2 week period without intervention</description>
          </group>
          <group group_id="O2">
            <title>Treatment Period</title>
            <description>2 week period with intervention - Anal tape</description>
          </group>
        </group_list>
        <measure>
          <title>Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)</title>
          <description>The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 &quot;excellent&quot; to 5 &quot;poor&quot; and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 &quot;extremely so&quot; to 6 &quot;not at all.&quot; The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lifestyle</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="0.69"/>
                    <measurement group_id="O2" value="3.3" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coping/Behaivoir</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.64"/>
                    <measurement group_id="O2" value="2.5" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression/Self-Perception</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.75"/>
                    <measurement group_id="O2" value="3.5" spread="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Embarrassment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" spread="0.67"/>
                    <measurement group_id="O2" value="2.65" spread="0.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>A 50% Reduction in the Number of Episodes of FI Per Week</title>
        <description>Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study</description>
        <time_frame>4 weeks</time_frame>
        <population>Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.</population>
        <group_list>
          <group group_id="O1">
            <title>Off Treatment</title>
            <description>2 week period without intervention</description>
          </group>
          <group group_id="O2">
            <title>Treatment Period</title>
            <description>2 week period with intervention&#xD;
Anal Tape</description>
          </group>
        </group_list>
        <measure>
          <title>A 50% Reduction in the Number of Episodes of FI Per Week</title>
          <description>Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study</description>
          <population>Note that this outcome was obtained by free text stool diaries that patients had to keep at home. Only 15 patient out of 20 provided full diaries, therefore the analysis is limited to 15 instead of all 20.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Wexner Score</title>
        <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off Treatment</title>
            <description>2 week period without intervention</description>
          </group>
          <group group_id="O2">
            <title>Treatment Period</title>
            <description>2 week period with intervention&#xD;
Anal Tape</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Wexner Score</title>
          <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="3.5"/>
                    <measurement group_id="O2" value="10.3" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Redction in Wexner Scale Compared to Baseline</title>
        <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Off Treatment</title>
            <description>2 week period without intervention</description>
          </group>
          <group group_id="O2">
            <title>Treatment Period</title>
            <description>2 week period with intervention&#xD;
Anal Tape</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Redction in Wexner Scale Compared to Baseline</title>
          <description>The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="1.7"/>
                    <measurement group_id="O2" value="1.95" spread="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>General Satisfaction</title>
        <description>General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
        <time_frame>2 weeks</time_frame>
        <population>Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Period</title>
            <description>2 week period with intervention&#xD;
Anal Tape</description>
          </group>
        </group_list>
        <measure>
          <title>General Satisfaction</title>
          <description>General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
          <population>Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.</population>
          <units>mm in VAS scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="50" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Willingness of the Patient to Continue Using the Anal Tape After the Study.</title>
        <description>Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
        <time_frame>4 weeks</time_frame>
        <population>Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Period</title>
            <description>2 week period with intervention&#xD;
Anal Tape</description>
          </group>
        </group_list>
        <measure>
          <title>Willingness of the Patient to Continue Using the Anal Tape After the Study.</title>
          <description>Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.</description>
          <population>Note that in 3 patients these data were missing, therefore the analysis if for 17 out of 20 participants.</population>
          <units>mm in VAS scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="50" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4 weeks study period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control Period - No Intervention</title>
          <description>Consiting of the first 14 days of the study during which patients were off treatment and baseline and safety data was collected</description>
        </group>
        <group group_id="E2">
          <title>Treatment Period - Anal Tape Provided</title>
          <description>Consiting of the second 14 days of the study (day 15 to 28) during which patients were provided with the &quot;anal tape&quot; device and during this period efficacy and safety data was collected.</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>other</default_vocab>
        <default_assessment>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="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Mild difficulty to remove the device</sub_title>
                <description>Mild difficulty to remove the device</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="20"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Short term, single center, open label</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Dan Livovsky</name_or_title>
      <organization>Shaare Zedek Medical Center</organization>
      <phone>+972525622398</phone>
      <email>danlivo@szmc.org.il</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/NCT02989545
org study id: Shaare Zedek Medical Center FI
nct id: NCT02989545
lead sponsor: 
has dmc: No
Fecal incontinence (FI), defined as the involuntary passage of stool for more than 3 months
      and is a devastating disease. The negative impact on quality of life has been consistently
      demonstrated. The prevalence of FI is probably underestimated in most studies. Currently
      conservative treatment is only modestly effective and surgical treatment is complex and
      expensive with less than optimal efficacy.

      The investigators developed an "anal tape" using a commercially available elastic band with a
      special adhesive that is approved for use in the skin. A special design of the tape can be
      applied to the skin surrounding the anus providing support and additional pressure forces to
      the anal sphincter.

      This is a 4 week, prospective, non blinded, cross-over study to explore the efficacy and
      safety of this device in patients with FI. The primary endpoint will be improvement in
      quality of life.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Any Improvment in the Fecal Incontince Quality of Life Scale (FIQoLs)
time frame: 2 weeks
description: The FIQoL is a validated, condition-specific tool that evaluates quality of life (QoL) in patients with fecal incontinence (FI) it consisting of 29 questions, subdivided into four domains: Lifestyle, Coping/Behavior, Depression/Self-perception, and Embarrassment. Item 1, general health, is graded from 1 "excellent" to 5 "poor" and is reversely scored. Items 2 to 28 are graded on a 4-point Likert-scale (1 = lower QoL). Item 29, FI specific depression, is graded from 1 "extremely so" to 6 "not at all." The average score for each domain is calculated separately and is calculated only if half or more of the items in the particular domain have been answered. Scales range from 1 to 5, with a 1 indicating a lower quality of life. Each domain or subscale is reported separately (Range 1 to 5), a total score including all four domains is not calculated.
measure: A 50% Reduction in the Number of Episodes of FI Per Week
time frame: 4 weeks
description: Number of pateints with reduction of more than 50% in the absolute number of FI events during each week of the study
measure: Mean Wexner Score
time frame: 2 weeks
description: The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
measure: Mean Redction in Wexner Scale Compared to Baseline
time frame: 2 weeks
description: The Wexner Scale is a measure of frequency and severity of anal incontinence. It comprises five items, three regarding frequency of involuntary passage of gas, liquid, or solid stool, frequency of pad wearing, and frequency of lifestyle alteration, scored in a 5-point Likert-scale (never=0, rarely=1, sometimes=2, usually=3, always=4). A sum of all scores from 0 to 20 is calculated with higher scores meaning more severe incontince.
measure: General Satisfaction
time frame: 2 weeks
description: General satisfaction with the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their satisfaction with the device between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
measure: Willingness of the Patient to Continue Using the Anal Tape After the Study.
time frame: 4 weeks
description: Willingness of the patient to continue using the device was assessed using a standard 100 mm visual analog scale. Patients were asked to grade their willingness to use the device in the future between 0 and 100 by drawing a perpendicular line in the 100 mm visual analog scale. Then the distance in mm was measured in mm from 0 to the perpendicular line and the score was calculated. Higher scores meaning better satisfaction.
arm group label: Off treatment
arm group type: No Intervention
description: 2 week period without intervention
arm group label: Treatment period
arm group type: Experimental
description: 2 week period with intervention
intervention type: Device
intervention name: Anal Tape
arm group label: Treatment period
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Shaare Zedek Medical Center
investigator full name: Dan Livovsky
investigator title: Dr. Dan M. Livovsky and Dr. Joseph Lysy
mesh term: Fecal Incontinence
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Short term, single center, open label
point of contact: 