<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/NCT04410822</url>
  </required_header>
  <id_info>
    <org_study_id>GREEN GRC01 FITAS</org_study_id>
    <nct_id>NCT04410822</nct_id>
  </id_info>
  <brief_title>Fecal Incontinence Type Assessment Scale</brief_title>
  <official_title>Fecal Incontinence Type Assessment Scale (FITAS): a New Tool to Distinguish Among Subgroups of Fecal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gérard Amarenco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre and Marie Curie University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the&#xD;
      International Continence Society. Urge FI is described as &quot;the inability to defer defecation&#xD;
      once the urge is perceived for long enough to reach a toilet&quot; and passive FI as &quot;the&#xD;
      involuntary leakage of faeces without forewarning&quot;. If several validated questionnaires are&#xD;
      available for FI, all of these questionnaires were developed to assess FI severity. In&#xD;
      literature, there is only a small number of studies that investigated clinical and&#xD;
      paraclinical characteristics of the different phenotype of FI. Moreover, there is an&#xD;
      heterogenicity in the definitions used for both urge and passive FI among these studies.&#xD;
      Lastly, patients with mixed FI were commonly excluded from these studies. It can be&#xD;
      established that there is a lack of validate tools to distinguish patients between subgroups&#xD;
      of FI.&#xD;
&#xD;
      The aim of the present study was to develop and to validate a new tool in order to&#xD;
      investigate and classify patients among the different subgroups of FI (active, passive and&#xD;
      mixed) defined by Rome IV criteria.&#xD;
&#xD;
      A monocentric prospective study was conducted in the Neuro-urology Department of a University&#xD;
      Hospital. All consecutive patients presenting in the Department with FI between December 2019&#xD;
      and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an&#xD;
      age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion&#xD;
      criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor&#xD;
      not treated, rectal or hemorrhoidal prolapses and specific inability regarding the&#xD;
      questionnaire (i.e. cognitive disorders, inability to read and to understand questions).&#xD;
&#xD;
      Phase 1: review of literature and qualitative interviews: To determine the dimensions of the&#xD;
      different subgroups of faecal incontinence, a literature review was performed using Pubmed&#xD;
      without date limitation until February 2020. The key words used were &quot;active faecal&#xD;
      incontinence&quot;, &quot;active fecal incontinence&quot;, &quot;passive faecal incontinence&quot;, &quot;passive fecal&#xD;
      incontinence&quot;, &quot;urge faecal incontinence&quot;, &quot;urge fecal incontinence&quot;, &quot;questionnaire&quot;,&#xD;
      &quot;scale&quot;, &quot;score&quot; and &quot;tool&quot;. In parallel to this literature review, semi-structured&#xD;
      interviews were performed on 20 patients from December 2019 to February 2020. During this&#xD;
      phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term&#xD;
      of all interviews, dimensions that were both the most used by patients and the most&#xD;
      discriminative among subgroups of FI were included in the questionnaire. Redaction of&#xD;
      questions was then performed by the panel expert.&#xD;
&#xD;
      Phase 2: feasibility study: The feasibility study was conducted from February to April 2020&#xD;
      on 30 patients. Each patient was asked to rate each version of the 2 questions with a&#xD;
      four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding&#xD;
      acceptance and comprehension of the questions.&#xD;
&#xD;
      Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a&#xD;
      validation study was performed from April to June 2020 on 100 consecutive patients. In order&#xD;
      to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the&#xD;
      questionnaire by mail with a second evaluation from 7 days to 10 days after the first one.&#xD;
      The &quot;intra-class correlation coefficient&quot; (ICC) was used to determine if these evaluations&#xD;
      could lead to similar results for each question. An ICC &gt; 0.70 was necessary to define&#xD;
      reproducibility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility of FITAS</measure>
    <time_frame>1 day</time_frame>
    <description>Patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The &quot;intra-class correlation coefficient&quot; (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC &gt; 0.70 was necessary to define reproducibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of FITAS</measure>
    <time_frame>1 day</time_frame>
    <description>Each patient was asked to rate acceptability of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>comprehension of FITAS</measure>
    <time_frame>1 day</time_frame>
    <description>Each patient was asked to rate comprehension of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Faecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Patients enrolled</arm_group_label>
    <description>an age older than 18 years old and symptoms of FI according to Rome IV criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical tests</intervention_name>
    <description>Semi-qualitative interviews and questionnaire FITAS</description>
    <arm_group_label>Patients enrolled</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients consulting in a tertiary center in neuro-urology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age older than 18 years old&#xD;
&#xD;
          -  symptoms of FI according to Rome IV criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anorectal fistula&#xD;
&#xD;
          -  Active inflammatory bowel disease&#xD;
&#xD;
          -  Anorectal malignant tumor not treated&#xD;
&#xD;
          -  Rectal or hemorrhoidal prolapses&#xD;
&#xD;
          -  Specific inability regarding the questionnaire (i.e. cognitive disorders, inability to&#xD;
             read and to understand questions)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charlotte Desprez</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Gérard Amarenco</investigator_full_name>
    <investigator_title>Head of Neuro-Urology Department</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410822
org study id: GREEN GRC01 FITAS
nct id: NCT04410822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Urge faecal incontinence (FI) and passive FI are the two subgroups of FI described by the
      International Continence Society. Urge FI is described as "the inability to defer defecation
      once the urge is perceived for long enough to reach a toilet" and passive FI as "the
      involuntary leakage of faeces without forewarning". If several validated questionnaires are
      available for FI, all of these questionnaires were developed to assess FI severity. In
      literature, there is only a small number of studies that investigated clinical and
      paraclinical characteristics of the different phenotype of FI. Moreover, there is an
      heterogenicity in the definitions used for both urge and passive FI among these studies.
      Lastly, patients with mixed FI were commonly excluded from these studies. It can be
      established that there is a lack of validate tools to distinguish patients between subgroups
      of FI.

      The aim of the present study was to develop and to validate a new tool in order to
      investigate and classify patients among the different subgroups of FI (active, passive and
      mixed) defined by Rome IV criteria.

      A monocentric prospective study was conducted in the Neuro-urology Department of a University
      Hospital. All consecutive patients presenting in the Department with FI between December 2019
      and June 2020 were screened for inclusion in the present study. Criteria of inclusion were an
      age older than 18 years old and symptoms of FI according to Rome IV criteria. Exclusion
      criteria were anorectal fistula, active inflammatory bowel disease, anorectal malignant tumor
      not treated, rectal or hemorrhoidal prolapses and specific inability regarding the
      questionnaire (i.e. cognitive disorders, inability to read and to understand questions).

      Phase 1: review of literature and qualitative interviews: To determine the dimensions of the
      different subgroups of faecal incontinence, a literature review was performed using Pubmed
      without date limitation until February 2020. The key words used were "active faecal
      incontinence", "active fecal incontinence", "passive faecal incontinence", "passive fecal
      incontinence", "urge faecal incontinence", "urge fecal incontinence", "questionnaire",
      "scale", "score" and "tool". In parallel to this literature review, semi-structured
      interviews were performed on 20 patients from December 2019 to February 2020. During this
      phase, a panel expert of 9 neuro-urologists and gastroenterologists was composed. At the term
      of all interviews, dimensions that were both the most used by patients and the most
      discriminative among subgroups of FI were included in the questionnaire. Redaction of
      questions was then performed by the panel expert.

      Phase 2: feasibility study: The feasibility study was conducted from February to April 2020
      on 30 patients. Each patient was asked to rate each version of the 2 questions with a
      four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding
      acceptance and comprehension of the questions.

      Phase 3: validation study: To investigate the psychometric properties of the questionnaire, a
      validation study was performed from April to June 2020 on 100 consecutive patients. In order
      to evaluate the FITAS' test reproducibility, patients were asked to answer a second time the
      questionnaire by mail with a second evaluation from 7 days to 10 days after the first one.
      The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations
      could lead to similar results for each question. An ICC > 0.70 was necessary to define
      reproducibility.
observational model: Cohort
time perspective: Prospective
measure: Reproducibility of FITAS
time frame: 1 day
description: Patients were asked to answer a second time the questionnaire by mail with a second evaluation from 7 days to 10 days after the first one. The "intra-class correlation coefficient" (ICC) was used to determine if these evaluations could lead to similar results for each question. An ICC > 0.70 was necessary to define reproducibility.
measure: Acceptability of FITAS
time frame: 1 day
description: Each patient was asked to rate acceptability of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.
measure: comprehension of FITAS
time frame: 1 day
description: Each patient was asked to rate comprehension of FITAS with a four-point Likert scale (A: very good, B: good, C: difficult, D: very difficult) regarding acceptance and comprehension of the questions.
arm group label: Patients enrolled
description: an age older than 18 years old and symptoms of FI according to Rome IV criteria.
intervention type: Other
intervention name: Clinical tests
description: Semi-qualitative interviews and questionnaire FITAS
arm group label: Patients enrolled
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor-Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Gérard Amarenco
investigator title: Head of Neuro-Urology Department
mesh term: Fecal Incontinence
sharing ipd: Undecided