<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/NCT03806855</url>
  </required_header>
  <id_info>
    <org_study_id>201810092RINB</org_study_id>
    <nct_id>NCT03806855</nct_id>
  </id_info>
  <brief_title>Health-related QoF Between OAB-wet and OAB-dry Women</brief_title>
  <official_title>Comparisons of Health-Related Quality of Life Between Overactive Bladder-wet and -Dry Women Based on Bladder Diary</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Overactive bladder syndrome (OAB) has a great negative impact on health-related quality of&#xD;
      life. In literatures, few studies reported the comparisons of health related quality of life&#xD;
      between OAB-wet and OAB-dry female patients. Thus, our aim is to compare the clinical&#xD;
      variables and health-related quality of life between OAB-wet and OAB-dry women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Between July 2009 and January 2018, all women with OAB visiting a medical center for&#xD;
      evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of&#xD;
      the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based&#xD;
      on the presence of at least one episode of urgency in her three-day bladder diary and with&#xD;
      the absence of stress urinary incontinence. The presence of at least one episode of urgency&#xD;
      associated incontinence was defined to be OAB-wet, otherwise, OAB-dry. Besides, only female&#xD;
      OAB patients with available King's Health Questionnaire (KHQ) data were reviewed in this&#xD;
      study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2009</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Quality of life</measure>
    <time_frame>Between July 2009 and January 2018</time_frame>
    <description>Use questionnaire to evaluate the difference in QoF of OAB-wet and OAB-dry women</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1071</enrollment>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>OAB-wet</arm_group_label>
    <description>The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OAB-dry</arm_group_label>
    <description>The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The absence of urgency associated incontinence was defined to be OAB-dry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Bladder diary</intervention_name>
    <description>3-day bladder diary</description>
    <arm_group_label>OAB-dry</arm_group_label>
    <arm_group_label>OAB-wet</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Between July 2009 and January 2018, all women older than 20-year-old with OAB visiting a&#xD;
        medical center for evaluation were enrolled.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. More than 20-year-old&#xD;
&#xD;
          2. Female&#xD;
&#xD;
          3. Diagnosed with overactive bladder by bladder diary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Younger than 20-year-old&#xD;
&#xD;
          2. Pregnant or planned to be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho-Hsiung Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.</citation>
    <PMID>19941278</PMID>
  </reference>
  <reference>
    <citation>Powell LC, Szabo SM, Walker D, Gooch K. The economic burden of overactive bladder in the United States: A systematic literature review. Neurourol Urodyn. 2018 Apr;37(4):1241-1249. doi: 10.1002/nau.23477. Epub 2018 Jan 13.</citation>
    <PMID>29331047</PMID>
  </reference>
  <reference>
    <citation>Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.</citation>
    <PMID>24456314</PMID>
  </reference>
  <reference>
    <citation>Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.</citation>
    <PMID>24007713</PMID>
  </reference>
  <reference>
    <citation>Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.</citation>
    <PMID>12811491</PMID>
  </reference>
  <reference>
    <citation>Onukwugha E, Zuckerman IH, McNally D, Coyne KS, Vats V, Mullins CD. The total economic burden of overactive bladder in the United States: a disease-specific approach. Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7.</citation>
    <PMID>19355803</PMID>
  </reference>
  <reference>
    <citation>Coyne KS, Sexton CC, Bell JA, Thompson CL, Dmochowski R, Bavendam T, Chen CI, Quentin Clemens J. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013 Mar;32(3):230-7. doi: 10.1002/nau.22295. Epub 2012 Jul 27.</citation>
    <PMID>22847394</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health Related Quality of Life</keyword>
  <keyword>Overactive Bladder</keyword>
  <keyword>Bladder Diary</keyword>
  <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/NCT03806855
org study id: 201810092RINB
nct id: NCT03806855
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Overactive bladder syndrome (OAB) has a great negative impact on health-related quality of
      life. In literatures, few studies reported the comparisons of health related quality of life
      between OAB-wet and OAB-dry female patients. Thus, our aim is to compare the clinical
      variables and health-related quality of life between OAB-wet and OAB-dry women.
Between July 2009 and January 2018, all women with OAB visiting a medical center for
      evaluation were reviewed. The classification of OAB-wet or OAB-dry is based on the record of
      the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based
      on the presence of at least one episode of urgency in her three-day bladder diary and with
      the absence of stress urinary incontinence. The presence of at least one episode of urgency
      associated incontinence was defined to be OAB-wet, otherwise, OAB-dry. Besides, only female
      OAB patients with available King's Health Questionnaire (KHQ) data were reviewed in this
      study.
observational model: Case-Only
time perspective: Retrospective
measure: Difference in Quality of life
time frame: Between July 2009 and January 2018
description: Use questionnaire to evaluate the difference in QoF of OAB-wet and OAB-dry women
arm group label: OAB-wet
description: The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet.
arm group label: OAB-dry
description: The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The absence of urgency associated incontinence was defined to be OAB-dry.
intervention type: Diagnostic Test
intervention name: Bladder diary
description: 3-day bladder diary
arm group label: OAB-dry
arm group label: OAB-wet
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Ho-Hsiung Lin, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
citation: Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.
PMID: 19941278
citation: Powell LC, Szabo SM, Walker D, Gooch K. The economic burden of overactive bladder in the United States: A systematic literature review. Neurourol Urodyn. 2018 Apr;37(4):1241-1249. doi: 10.1002/nau.23477. Epub 2018 Jan 13.
PMID: 29331047
citation: Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Economic burden of urgency urinary incontinence in the United States: a systematic review. J Manag Care Pharm. 2014 Feb;20(2):130-40. doi: 10.18553/jmcp.2014.20.2.130.
PMID: 24456314
citation: Milsom I, Coyne KS, Nicholson S, Kvasz M, Chen CI, Wein AJ. Global prevalence and economic burden of urgency urinary incontinence: a systematic review. Eur Urol. 2014 Jan;65(1):79-95. doi: 10.1016/j.eururo.2013.08.031. Epub 2013 Aug 27.
PMID: 24007713
citation: Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PMID: 12811491
citation: Onukwugha E, Zuckerman IH, McNally D, Coyne KS, Vats V, Mullins CD. The total economic burden of overactive bladder in the United States: a disease-specific approach. Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7.
PMID: 19355803
citation: Coyne KS, Sexton CC, Bell JA, Thompson CL, Dmochowski R, Bavendam T, Chen CI, Quentin Clemens J. The prevalence of lower urinary tract symptoms (LUTS) and overactive bladder (OAB) by racial/ethnic group and age: results from OAB-POLL. Neurourol Urodyn. 2013 Mar;32(3):230-7. doi: 10.1002/nau.22295. Epub 2012 Jul 27.
PMID: 22847394
responsible party type: Sponsor
sharing ipd: No