<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/NCT03803878</url>
  </required_header>
  <id_info>
    <org_study_id>2018-162-KY</org_study_id>
    <nct_id>NCT03803878</nct_id>
  </id_info>
  <brief_title>Translation and Validation of MESA Questionnaire of Chinese Language Version</brief_title>
  <official_title>Medical, Epidemiologic, and Social Aspects of Aging (MESA) Urinary Incontinence Questionnaire: Translation and Validation of the Chinese Language Version in Women With Urgency-predominant Mixed Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</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 study is to translate the Medical, Epidemiologic, and Social aspects of Aging (MESA)&#xD;
      urinary incontinence questionnaire into a Chinese language version and test the reliability&#xD;
      and validity among women with urgency-predominant mixed urinary incontinence.&#xD;
&#xD;
      The hypothesis is that the Chinese language version of the MESA questionnaire will have&#xD;
      adequate measurement properties (e.g. reliability and validity).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mixed urinary incontinence(MUI) is regarded as urgency-predominant when urgency incontinence&#xD;
      episodes dominate over stress incontinence episodes, and vice versa. The treatment of MUI&#xD;
      often begins with the most bothersome symptoms.&#xD;
&#xD;
      MESA questionnaire is a reliable and validated tool to evaluate the severity and predominance&#xD;
      of stress or urgency urinary incontinence. At present, it hasn't been translated into a&#xD;
      Chinese language version and validated.&#xD;
&#xD;
      The validation study of MESA questionnaire is embedded in a randomized controlled trial&#xD;
      conducted among female patients, of which the data will be collected and analysed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.</measure>
    <time_frame>screening and baseline periods</time_frame>
    <description>The extended clinical evaluation mainly includes physical examination, 3-day voiding diary, cough stress teat, urinalysis and residual urine volume by ultrasonography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The criteria validity of MESA questionnaire compared with International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) in severity assessing among women with urgency-predominant mixed urinary incontinence.</measure>
    <time_frame>baseline</time_frame>
    <description>ICIQ SF is a validated questionnaire to evaluate both the severity of incontinence symptoms and influence on QoL in the past four weeks. The questionnaire is consisted of four items, including frequency, leakage amount, impact on QoL and the cause of urinary incontinence. The total score of the ICIQ SF ranges from 0 to 21, with a higher score indicating worse symptoms and QoL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.</measure>
    <time_frame>baseline</time_frame>
    <description>In 3-day voiding diary, the type and episodes of incontinence are all recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The test-retest reliability of MESA questionnaire</measure>
    <time_frame>screening and baseline periods</time_frame>
    <description>The test-retest reliability of MESA will be evaluated at the screening and baseline period with about one- to two-week interval among women with urgency-predominant mixed urinary incontinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The responsiveness of MESA questionnaire</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>The responsiveness of MESA questionnaire will be evaluated before and after the treatment among women with urgency-predominant mixed urinary incontinence compared with 3-day voiding diary and ICIQ SF.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Questionnaire</condition>
  <condition>Mixed Urinary Incontinence</condition>
  <condition>Urgency-predominant Mixed Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Group 1 is anticipated to consist of 300 women with MUI, and the categorization function of MESA questionnaire will be validated among those patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>Group 2 is anticipated to consist of 282 women with urgency-predominant MUI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>Group 3 is anticipated to consist of 94 women with urgency-predominant MUI.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The questionnaire validation is targeted at women with urgency-predominant mixed urinary&#xD;
        incontinence.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Female patients diagnosed with MUI in accordance with EAU guideline by history taking,&#xD;
             physical examination, laboratory tests and specialist diagnosis;&#xD;
&#xD;
          2. Age between 18 and 80 years old;&#xD;
&#xD;
          3. At least 4 episodes of UUI in 3-day voiding diary;&#xD;
&#xD;
          4. With MUI for at least 3 months, and urgency urinary incontinence dominates more than&#xD;
             50% of the total incontinence episodes in 3-day voiding diary;&#xD;
&#xD;
          5. Positive cough test;&#xD;
&#xD;
          6. A voluntarily-signed written informed content. For patients in group 1, inclusion&#xD;
             criteria of 1), 2), 5) and 6) are required to meet. Those also meeting the criteria of&#xD;
             3) and 4) will enter group 2 at the same time.&#xD;
&#xD;
        For patients in group 2 and groups 3, all inclusion criteria are required to meet.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Having pure SUI, pure UUI, overflow UI or neurogenic bladder;&#xD;
&#xD;
          2. Uncontrolled urinary tract infection;&#xD;
&#xD;
          3. Tumor in urinary system or pelvic organs;&#xD;
&#xD;
          4. Pelvic organ prolapse≥degreeⅡ;&#xD;
&#xD;
          5. Residual urine volume≥100ml;&#xD;
&#xD;
          6. Maximum flow rate&lt;15ml/s;&#xD;
&#xD;
          7. In the past 1 month, receiving treatment of acupuncture or positive medications&#xD;
             targeted at incontinence, such as antimuscarinic drugs;&#xD;
&#xD;
          8. Underwent anti-incontinence or pelvic organ surgery, including metrectomy;&#xD;
&#xD;
          9. Complication of severe diabetes or hypertension;&#xD;
&#xD;
         10. Complication of diseases in nervous system that could hamper hypourethral function,&#xD;
             such as multiple sclerosis, senile dementia, Parkinson's disease, spinal cord injury,&#xD;
             cauda equina nerve injury and multiple system atrophy;&#xD;
&#xD;
         11. Severe complications in cardiac, lungs, cerebrum, hepar, renal system, psychonosology&#xD;
             and coagulation function, or obvious cognitive disability;&#xD;
&#xD;
         12. Installed a cardiac pacemaker;&#xD;
&#xD;
         13. Allergic to Solifenacin or with contraindications to antimuscarinic drug, including&#xD;
             urinary retention, gastrointestinal peristalsis paralysis, myasthenia gravis,&#xD;
             ulcerative colitis and angle-closure glaucoma;&#xD;
&#xD;
         14. Allergic to metal or intolerant to the stimulation of electroacupuncture;&#xD;
&#xD;
         15. Pregnant or plan to conceive in the future 1 year, or delivery in the past one year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhishun Liu, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Guang An Men Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhishun Liu, PhD</last_name>
    <phone>86-010-88002331</phone>
    <email>zhishunjournal@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuanjie Sun, Master</last_name>
    <phone>86-010-18810337542</phone>
    <email>puzhisun@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guang An Men Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100053</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuanjie Sun, Master</last_name>
      <phone>8610-010-88002331</phone>
      <email>puzhisun@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>September 13, 2020</last_update_submitted>
  <last_update_submitted_qc>September 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Liu Zhishun</investigator_full_name>
    <investigator_title>Principle investigator</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>Enuresis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03803878
org study id: 2018-162-KY
nct id: NCT03803878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is to translate the Medical, Epidemiologic, and Social aspects of Aging (MESA)
      urinary incontinence questionnaire into a Chinese language version and test the reliability
      and validity among women with urgency-predominant mixed urinary incontinence.

      The hypothesis is that the Chinese language version of the MESA questionnaire will have
      adequate measurement properties (e.g. reliability and validity).
Mixed urinary incontinence(MUI) is regarded as urgency-predominant when urgency incontinence
      episodes dominate over stress incontinence episodes, and vice versa. The treatment of MUI
      often begins with the most bothersome symptoms.

      MESA questionnaire is a reliable and validated tool to evaluate the severity and predominance
      of stress or urgency urinary incontinence. At present, it hasn't been translated into a
      Chinese language version and validated.

      The validation study of MESA questionnaire is embedded in a randomized controlled trial
      conducted among female patients, of which the data will be collected and analysed.
observational model: Case-Only
time perspective: Prospective
measure: The criteria validity of MESA questionnaire compared with extended clinical evaluation in deciding predominant components of MUI.
time frame: screening and baseline periods
description: The extended clinical evaluation mainly includes physical examination, 3-day voiding diary, cough stress teat, urinalysis and residual urine volume by ultrasonography.
measure: The criteria validity of MESA questionnaire compared with International Consultation on Incontinence Questionnaire Short Form (ICIQ SF) in severity assessing among women with urgency-predominant mixed urinary incontinence.
time frame: baseline
description: ICIQ SF is a validated questionnaire to evaluate both the severity of incontinence symptoms and influence on QoL in the past four weeks. The questionnaire is consisted of four items, including frequency, leakage amount, impact on QoL and the cause of urinary incontinence. The total score of the ICIQ SF ranges from 0 to 21, with a higher score indicating worse symptoms and QoL.
measure: The criteria validity of MESA questionnaire compared with 3-day voiding diary in severity assessing among women with urgency-predominant mixed urinary incontinence.
time frame: baseline
description: In 3-day voiding diary, the type and episodes of incontinence are all recorded.
measure: The test-retest reliability of MESA questionnaire
time frame: screening and baseline periods
description: The test-retest reliability of MESA will be evaluated at the screening and baseline period with about one- to two-week interval among women with urgency-predominant mixed urinary incontinence.
measure: The responsiveness of MESA questionnaire
time frame: baseline, week 12
description: The responsiveness of MESA questionnaire will be evaluated before and after the treatment among women with urgency-predominant mixed urinary incontinence compared with 3-day voiding diary and ICIQ SF.
arm group label: Group 1
description: Group 1 is anticipated to consist of 300 women with MUI, and the categorization function of MESA questionnaire will be validated among those patients.
arm group label: Group 2
description: Group 2 is anticipated to consist of 282 women with urgency-predominant MUI.
arm group label: Group 3
description: Group 3 is anticipated to consist of 94 women with urgency-predominant MUI.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Zhishun Liu, PhD
role: Study Chair
affiliation: Guang An Men Hospital
last name: Zhishun Liu, PhD
phone: 86-010-88002331
email: zhishunjournal@163.com
last name: Yuanjie Sun, Master
phone: 86-010-18810337542
email: puzhisun@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Liu Zhishun
investigator title: Principle investigator
mesh term: Urinary Incontinence
mesh term: Enuresis