<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/NCT03801239</url>
  </required_header>
  <id_info>
    <org_study_id>01/2019</org_study_id>
    <nct_id>NCT03801239</nct_id>
  </id_info>
  <brief_title>Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS)</brief_title>
  <official_title>Reliability of Polish-Version Overactive Bladder Syndrom Scores (OABSS) Questionnaire and the Correlation of OABSS With the Results of UDI-6 and IIQ-7 Questionnaires</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>
      The aim of this study was to develop and assess the effectiveness of a Polish version of&#xD;
      OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7&#xD;
      questionnaires&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The translation into Polish followed standardized procedures. Women aged between 18-75 years&#xD;
      were included into the study. All patients were recruited from women attending the Outpatient&#xD;
      Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed&#xD;
      in 290 cases; OAB in 283 patients and 249 had MUI (confirmed by medical history, and&#xD;
      urodynamic investigation). All patients completed the Polish version of the OABSS on two&#xD;
      separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of OABSS questionnaire and Urodynamic study</measure>
    <time_frame>2 weeks</time_frame>
    <description>Results of polish version of OABSS are correlated with Urodynamic study results</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of OABSS questionnaire with UDI-6 results</measure>
    <time_frame>2 weeks</time_frame>
    <description>Results of polish version of OABSS are correlated with UDI-6 results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of OABSS questionnaire with IIQ-7 results</measure>
    <time_frame>2 weeks</time_frame>
    <description>Results of polish version of OABSS are correlated with IIQ-7 results</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">822</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>patients with Overactive Bladder (OAB)</arm_group_label>
    <description>Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with Mixed Urinary incontinence (MUI)</arm_group_label>
    <description>Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with Stress Urinary Incontinence (SUI)</arm_group_label>
    <description>Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Urodynamic Study</intervention_name>
    <description>during visit Week 0 patients had urodynamic study</description>
    <arm_group_label>patients with Mixed Urinary incontinence (MUI)</arm_group_label>
    <arm_group_label>patients with Overactive Bladder (OAB)</arm_group_label>
    <arm_group_label>patients with Stress Urinary Incontinence (SUI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>OABSS questionnaire fulfilment</intervention_name>
    <description>during visit Week 0 and Week 2 patients fulfilled OABSS</description>
    <arm_group_label>patients with Mixed Urinary incontinence (MUI)</arm_group_label>
    <arm_group_label>patients with Overactive Bladder (OAB)</arm_group_label>
    <arm_group_label>patients with Stress Urinary Incontinence (SUI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>UDI-6 questionnaire fulfilment</intervention_name>
    <description>during visit Week 2 patients fulfilled UDI-6 questionnaire</description>
    <arm_group_label>patients with Mixed Urinary incontinence (MUI)</arm_group_label>
    <arm_group_label>patients with Overactive Bladder (OAB)</arm_group_label>
    <arm_group_label>patients with Stress Urinary Incontinence (SUI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IIQ-7 questionnaire fulfilment</intervention_name>
    <description>during visit Week 2 patients fulfilled IIQ-7 questionnaire</description>
    <arm_group_label>patients with Mixed Urinary incontinence (MUI)</arm_group_label>
    <arm_group_label>patients with Overactive Bladder (OAB)</arm_group_label>
    <arm_group_label>patients with Stress Urinary Incontinence (SUI)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients were recruited from women attending the Outpatient Clinic of the 2nd&#xD;
        Gynecology Department of the Medical University in Lublin. SUI was observed in 290 cases;&#xD;
        OAB in 283 patients and 249 had MUI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed Urinary Incontinence in Urodynamic study (SUI, OAB, MUI)&#xD;
&#xD;
          -  female aged 18-75 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  malignant disorders&#xD;
&#xD;
          -  uncontrolled diabetes&#xD;
&#xD;
          -  inability to understand informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of Lublin</name>
      <address>
        <city>Lublin</city>
        <state>Lubelskie</state>
        <zip>20-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Andrzej Wróbel</investigator_full_name>
    <investigator_title>PhD, MD associated professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03801239
org study id: 01/2019
nct id: NCT03801239
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to develop and assess the effectiveness of a Polish version of
      OABSS and to correlate the OABSS with urodynamic study results and UDI-6, IIQ-7
      questionnaires
The translation into Polish followed standardized procedures. Women aged between 18-75 years
      were included into the study. All patients were recruited from women attending the Outpatient
      Clinic of the 2nd Gynecology Department of the Medical University in Lublin. SUI was observed
      in 290 cases; OAB in 283 patients and 249 had MUI (confirmed by medical history, and
      urodynamic investigation). All patients completed the Polish version of the OABSS on two
      separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
observational model: Cohort
time perspective: Retrospective
measure: Correlation of OABSS questionnaire and Urodynamic study
time frame: 2 weeks
description: Results of polish version of OABSS are correlated with Urodynamic study results
measure: Correlation of OABSS questionnaire with UDI-6 results
time frame: 2 weeks
description: Results of polish version of OABSS are correlated with UDI-6 results
measure: Correlation of OABSS questionnaire with IIQ-7 results
time frame: 2 weeks
description: Results of polish version of OABSS are correlated with IIQ-7 results
arm group label: patients with Overactive Bladder (OAB)
description: Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
arm group label: patients with Mixed Urinary incontinence (MUI)
description: Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
arm group label: patients with Stress Urinary Incontinence (SUI)
description: Patients completed the Polish version of the OABSS on two separate visits: Week 0 and Week 2 and additionally UDI-6, IIQ-7 during visit- Week 2.
intervention type: Diagnostic Test
intervention name: Urodynamic Study
description: during visit Week 0 patients had urodynamic study
arm group label: patients with Mixed Urinary incontinence (MUI)
arm group label: patients with Overactive Bladder (OAB)
arm group label: patients with Stress Urinary Incontinence (SUI)
intervention type: Diagnostic Test
intervention name: OABSS questionnaire fulfilment
description: during visit Week 0 and Week 2 patients fulfilled OABSS
arm group label: patients with Mixed Urinary incontinence (MUI)
arm group label: patients with Overactive Bladder (OAB)
arm group label: patients with Stress Urinary Incontinence (SUI)
intervention type: Diagnostic Test
intervention name: UDI-6 questionnaire fulfilment
description: during visit Week 2 patients fulfilled UDI-6 questionnaire
arm group label: patients with Mixed Urinary incontinence (MUI)
arm group label: patients with Overactive Bladder (OAB)
arm group label: patients with Stress Urinary Incontinence (SUI)
intervention type: Diagnostic Test
intervention name: IIQ-7 questionnaire fulfilment
description: during visit Week 2 patients fulfilled IIQ-7 questionnaire
arm group label: patients with Mixed Urinary incontinence (MUI)
arm group label: patients with Overactive Bladder (OAB)
arm group label: patients with Stress Urinary Incontinence (SUI)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Andrzej Wróbel
investigator title: PhD, MD associated professor
mesh term: Urinary Incontinence
mesh term: Urinary Bladder, Overactive
sharing ipd: No