<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/NCT03810027</url>
  </required_header>
  <id_info>
    <org_study_id>201810091RIND</org_study_id>
    <nct_id>NCT03810027</nct_id>
  </id_info>
  <brief_title>Prevalence and Risk Factors Nocturnal Polyuria in Female OAB</brief_title>
  <official_title>Prevalence and Risk Factors of Nocturnal Polyuria in Female Overactive Bladder Syndrome</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>
      Nocturnal polyuria may decrease the treatment efficacy of overactive bladder syndrome (OAB);&#xD;
      and adjuvant medication, such as desmopressin, may be needed for the treatment of nocturnal&#xD;
      polyuria. The knowledge of prevalence and risk factors of nocturnal polyuria might be&#xD;
      important for the treatment of OAB. Thus, our aim is to describe the prevalence and risk&#xD;
      factors of nocturnal polyuria in women with OAB.&#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.&#xD;
&#xD;
      Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour&#xD;
      voided volume was greater than 33% for ≥65-year-old women, and when the proportion of&#xD;
      nighttime voided volume over 24-hour voided volume was greater than 20% for &lt;65-year-old&#xD;
      women.&#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>Nocturnal polyuria</measure>
    <time_frame>Between July 2009 and January 2018</time_frame>
    <description>Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for &lt;65 year-old women.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1071</enrollment>
  <condition>Nocturia</condition>
  <arm_group>
    <arm_group_label>OAB with nocturnal polyuria</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. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for &lt;65 year-old women. Precence of nocturnal polyuria will be classified in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OAB without nocturnal polyuria</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. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for &lt;65 year-old women. Absence of nocturnal polyuria will be classified in this group.</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 with nocturnal polyuria</arm_group_label>
    <arm_group_label>OAB without nocturnal polyuria</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Between July 2009 and January 2018, all women elder 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&#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>December 2018</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nocturnal polyuria</keyword>
  <keyword>Overactive bladder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polyuria</mesh_term>
    <mesh_term>Nocturia</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/NCT03810027
org study id: 201810091RIND
nct id: NCT03810027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nocturnal polyuria may decrease the treatment efficacy of overactive bladder syndrome (OAB);
      and adjuvant medication, such as desmopressin, may be needed for the treatment of nocturnal
      polyuria. The knowledge of prevalence and risk factors of nocturnal polyuria might be
      important for the treatment of OAB. Thus, our aim is to describe the prevalence and risk
      factors of nocturnal polyuria in women with OAB.
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.

      Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour
      voided volume was greater than 33% for ≥65-year-old women, and when the proportion of
      nighttime voided volume over 24-hour voided volume was greater than 20% for <65-year-old
      women.
observational model: Case-Only
time perspective: Retrospective
measure: Nocturnal polyuria
time frame: Between July 2009 and January 2018
description: Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women.
arm group label: OAB with nocturnal polyuria
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. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Precence of nocturnal polyuria will be classified in this group.
arm group label: OAB without nocturnal polyuria
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. Nocturnal polyuria was defined when the proportion of nighttime voided volume over 24-hour voided volume was greater than 33% for ≥65 year-old women, and when the proportion of nighttime voided volume over 24-hour voided volume was greater than 20% for <65 year-old women. Absence of nocturnal polyuria will be classified in this group.
intervention type: Diagnostic Test
intervention name: Bladder diary
description: 3-day bladder diary
arm group label: OAB with nocturnal polyuria
arm group label: OAB without nocturnal polyuria
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
mesh term: Polyuria
mesh term: Nocturia
sharing ipd: No