<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/NCT04483609</url>
  </required_header>
  <id_info>
    <org_study_id>2018/23-21</org_study_id>
    <nct_id>NCT04483609</nct_id>
  </id_info>
  <brief_title>SF-QUALIVEEN Turkish Validity and Reliability Study</brief_title>
  <official_title>SF-QUALIVEEN Turkish Cultural Adaptation, Validity and Reliability Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Aydın University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Aydın University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence&#xD;
      has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a&#xD;
      significant deterioration in the quality of life of people with MS. In chronic diseases such&#xD;
      as MS, patients experiences need to be measured directly in order to have information about&#xD;
      patients perceptions about the effect of the disease on quality of life. However, there are a&#xD;
      small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated&#xD;
      scale for patients with MS who assess the urinary-specific quality of life by examining the&#xD;
      impact of a wide range of bladder problems.The aim of our study is to make the Turkish&#xD;
      cultural adaptation, validity and reliability of the SF-Qualiveen scale.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability&#xD;
      of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory&#xD;
      (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple&#xD;
      sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients&#xD;
      with multiple sclerosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SF-Qualiveen score</measure>
    <time_frame>Baseline</time_frame>
    <description>To evaluate the impact of urological problems on quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urogenital Distress Inventory (UDI-6)</measure>
    <time_frame>Baseline</time_frame>
    <description>To assess problems caused by urinary symptoms</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">63</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>pre-test Group</arm_group_label>
    <description>10 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation and Reliability Group</arm_group_label>
    <description>80 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire administration pre test</intervention_name>
    <description>After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.</description>
    <arm_group_label>pre-test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire administration validation and reliability</intervention_name>
    <description>After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.</description>
    <arm_group_label>Validation and Reliability Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pre-test: 10 patients with multiple sclerosis will be evaluated.Inclusion and exlusion&#xD;
        criteria listed above.&#xD;
&#xD;
        Validation and reliability: 70 patients with multiple sclerosis will be evaluated.Inclusion&#xD;
        and exlusion criteria listed above.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18-65;&#xD;
&#xD;
          2. definitive diagnosis of MS according to McDonald criteria;&#xD;
&#xD;
          3. ability to read and write in Turkish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. acute attacks of MS (within 3 months);&#xD;
&#xD;
          2. cognitive impairment (Mini Mental test result 24 points and below);&#xD;
&#xD;
          3. any chronic disease other than MS;&#xD;
&#xD;
          4. active malignant tumors;&#xD;
&#xD;
          5. symptomatic urinary tract infections;&#xD;
&#xD;
          6. patients who changed treatment within the test-retest period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>İstanbul Üniversitesi-Cerrahpaşa</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>June 14, 2021</last_update_submitted>
  <last_update_submitted_qc>June 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Aydın University</investigator_affiliation>
    <investigator_full_name>Uğur OVACIK</investigator_full_name>
    <investigator_title>Instructor</investigator_title>
  </responsible_party>
  <keyword>multiple sclerosis</keyword>
  <keyword>urological dysfunction</keyword>
  <keyword>assessment</keyword>
  <keyword>scale</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT04483609
org study id: 2018/23-21
nct id: NCT04483609
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Urological dysfunction is common in patients with Multiple Sclerosis (MS) and its prevalence
      has been reported at a high rate of 32-97%. Bladder dysfunction is associated with a
      significant deterioration in the quality of life of people with MS. In chronic diseases such
      as MS, patients experiences need to be measured directly in order to have information about
      patients perceptions about the effect of the disease on quality of life. However, there are a
      small number of valid and reliable Turkish scales on this subject.SF-Qualiveen is a validated
      scale for patients with MS who assess the urinary-specific quality of life by examining the
      impact of a wide range of bladder problems.The aim of our study is to make the Turkish
      cultural adaptation, validity and reliability of the SF-Qualiveen scale.
The aim of this study is to reveal the Turkish cultural adaptation, validity and reliability
      of the SF-Qualiveen scale. In our study, Sf-Qualiveen and Urogenital Distress Inventory
      (UDI-6) scales will be used. Pre-testing will be done in 10 patients with multiple
      sclerosis.Then, the validity and reliability of the scale will be performed in 80 patients
      with multiple sclerosis.
observational model: Case-Only
time perspective: Cross-Sectional
measure: SF-Qualiveen score
time frame: Baseline
description: To evaluate the impact of urological problems on quality of life
measure: Urogenital Distress Inventory (UDI-6)
time frame: Baseline
description: To assess problems caused by urinary symptoms
arm group label: pre-test Group
description: 10 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period.
arm group label: Validation and Reliability Group
description: 80 people with multiple sclerosis. The eligibility criteria were: (1) age 18-65; (2) definitive diagnosis of MS according to McDonald criteria; (3) ability to read and write in Turkish. The exclusion criteria are: (1) acute attacks of MS (within 3 months); (2) cognitive impairment (Mini Mental test result 24 points and below); (3) any chronic disease other than MS; (4) active malignant tumors; (5) symptomatic urinary tract infections; (6) patients who changed treatment within the test-retest period.
intervention type: Other
intervention name: Questionnaire administration pre test
description: After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.
arm group label: pre-test Group
intervention type: Other
intervention name: Questionnaire administration validation and reliability
description: After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.
arm group label: Validation and Reliability Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Aydın University
investigator full name: Uğur OVACIK
investigator title: Instructor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided