<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/NCT04433715</url>
  </required_header>
  <id_info>
    <org_study_id>01/2020</org_study_id>
    <nct_id>NCT04433715</nct_id>
  </id_info>
  <brief_title>Identification of the UDI-6 and the IIQ-7 Cutoff Scores in Urinary Incontinent Women</brief_title>
  <official_title>Identification of the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 Cutoff Scores in Urinary Incontinent Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lublin</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>
      Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)&#xD;
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose&#xD;
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on&#xD;
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We&#xD;
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.&#xD;
&#xD;
      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without&#xD;
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.&#xD;
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6&#xD;
      (n=134) and asymptomatic ICIQ &lt; 6 (n=60). The Receiver Operating Characteristics (ROC) curve&#xD;
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI&#xD;
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6&#xD;
      and IIQ-7 Total Score efficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)&#xD;
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose&#xD;
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on&#xD;
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We&#xD;
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.&#xD;
&#xD;
      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without&#xD;
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.&#xD;
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6&#xD;
      (n=134) and asymptomatic ICIQ &lt; 6 (n=60). The Receiver Operating Characteristics (ROC) curve&#xD;
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI&#xD;
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6&#xD;
      and IIQ-7 Total Score efficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2016</start_date>
  <completion_date type="Actual">July 1, 2016</completion_date>
  <primary_completion_date type="Actual">June 30, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>patients with sympthomatic UI- ICIQ-SF ≥6</measure>
    <time_frame>01.03.2016-30.06.2016</time_frame>
    <description>symptomatic ICIQ-SF ≥6</description>
  </primary_outcome>
  <primary_outcome>
    <measure>asymphomatic patients ICIQ-SF&lt;6</measure>
    <time_frame>01.03.2016-30.06.2016</time_frame>
    <description>ICIQ&lt;6</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">155</enrollment>
  <condition>Quality of Life</condition>
  <condition>Urinary Incontinence,Stress</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>patients with UI symptoms</arm_group_label>
    <description>All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients without UI symptoms</arm_group_label>
    <description>All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ICIQ-SF</intervention_name>
    <description>All participants completed ICIQ-SF,</description>
    <arm_group_label>patients with UI symptoms</arm_group_label>
    <arm_group_label>patients without UI symptoms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>UDI-6</intervention_name>
    <description>All participants completed UDI-6</description>
    <arm_group_label>patients with UI symptoms</arm_group_label>
    <arm_group_label>patients without UI symptoms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IIQ-7</intervention_name>
    <description>All participants completed IIQ-7</description>
    <arm_group_label>patients with UI symptoms</arm_group_label>
    <arm_group_label>patients without UI symptoms</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study involved a total of 205 women aged between 31 and 83 years who were recruited&#xD;
        from women attending the Gynecological Outpatient Clinic due to UI symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  UI symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  lack of consent, oncological diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>31 Years</minimum_age>
    <maximum_age>83 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Rechberger</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Lublin</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Katarzyna Skorupska</name>
      <address>
        <city>Lublin</city>
        <zip>20-059</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Katarzyna Skorupska</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Incontinence Impact Questionnaire-7</keyword>
  <keyword>Urogenital Distress Inventory-6</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We would like to share UDI-6 and IIQ-7 cutoff scores</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>2020</ipd_time_frame>
    <ipd_access_criteria>email co PI kasiaperzylo@hotmail.com</ipd_access_criteria>
  </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/NCT04433715
org study id: 01/2020
nct id: NCT04433715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6
      (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6
      and IIQ-7 Total Score efficiency.
Purpose Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire-7 (IIQ-7)
      and The International Consultation on Incontinence (ICIQ-SF) Short Form are used to diagnose
      individuals with urinary incontinence (UI) and to assess the impact of the dysfunction on
      patient quality of life. While ICIQ-SF has fixed cutoff values - UDI-6 and IIQ-7 do not. We
      aimed to find the cutoff scores for UDI-6 and IIQ-7 in women with UI.

      Methods The study involved 205 women aged between 31 and 83 years - 155 with, and 50 without
      UI symptoms. All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
      Patients were categorized according to their ICIQ-SF scores, as symptomatic ICIQ-SF ≥6
      (n=134) and asymptomatic ICIQ < 6 (n=60). The Receiver Operating Characteristics (ROC) curve
      was used to test how well UDI-6 allowed a discrimination between patients suffering from UI
      and those who do not. AUC (Area under Curve) statistic was calculated to measure the UDI-6
      and IIQ-7 Total Score efficiency.
observational model: Case-Control
time perspective: Prospective
measure: patients with sympthomatic UI- ICIQ-SF ≥6
time frame: 01.03.2016-30.06.2016
description: symptomatic ICIQ-SF ≥6
measure: asymphomatic patients ICIQ-SF<6
time frame: 01.03.2016-30.06.2016
description: ICIQ<6
arm group label: patients with UI symptoms
description: All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
arm group label: patients without UI symptoms
description: All participants completed all three questionnaires: ICIQ-SF, UDI-6 and IIQ-7.
intervention type: Diagnostic Test
intervention name: ICIQ-SF
description: All participants completed ICIQ-SF,
arm group label: patients with UI symptoms
arm group label: patients without UI symptoms
intervention type: Diagnostic Test
intervention name: UDI-6
description: All participants completed UDI-6
arm group label: patients with UI symptoms
arm group label: patients without UI symptoms
intervention type: Diagnostic Test
intervention name: IIQ-7
description: All participants completed IIQ-7
arm group label: patients with UI symptoms
arm group label: patients without UI symptoms
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 31 Years
maximum age: 83 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tomasz Rechberger
role: Study Director
affiliation: Medical University of Lublin
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Katarzyna Skorupska
investigator title: Principal Investigator
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Yes
ipd description: We would like to share UDI-6 and IIQ-7 cutoff scores
ipd info type: Study Protocol
ipd time frame: 2020
ipd access criteria: email co PI kasiaperzylo@hotmail.com