<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/NCT03251300</url>
  </required_header>
  <id_info>
    <org_study_id>106001-F</org_study_id>
    <nct_id>NCT03251300</nct_id>
  </id_info>
  <brief_title>Mirabegron for Female OAB Patients: Comparison of Daytime and Nighttime Dosing</brief_title>
  <official_title>Mirabegron for Female Patients With Overactive Bladder Syndrome: Comparison of Daytime and Nighttime Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Far Eastern Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Far Eastern Memorial Hospital</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>
      The aim of this study is to elucidate whether night-time dosing of mirebegron can improve&#xD;
      nocturia, compared with daytime dosing of mirabegron.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of&#xD;
      nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from&#xD;
      a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with&#xD;
      nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to&#xD;
      elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.&#xD;
&#xD;
      Patients and Methods: The investigators will perform a prospective randomized controlled&#xD;
      trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics&#xD;
      and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron.&#xD;
      All enrolled OAB women will be allocated to two groups (group A and B). The women in group A&#xD;
      will receive daytime dosing of mirabegron treatment; and the women in group B will receive&#xD;
      nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency&#xD;
      Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health&#xD;
      questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron&#xD;
      treatment. STATA software is used for statistical analyses.&#xD;
&#xD;
      Possible Results: The investigators can answer whether night-time dosing of mirabegron can&#xD;
      improve nocturia, compared with daytime dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nocturia episodes</measure>
    <time_frame>12 weeks</time_frame>
    <description>comparison of baseline and post-treatment nocturia episodes from bladder diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of nocturia</measure>
    <time_frame>12 weeks</time_frame>
    <description>comparison of baseline and post-treatment severity of nocturia from questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Overactive Bladder Syndrome</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>daytime dosing of mirabegron</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nighttime dosing of mirabegron</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>daytime dosing of mirabegron</intervention_name>
    <description>All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron</description>
    <arm_group_label>group A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nighttime dosing of mirabegron</intervention_name>
    <description>All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron</description>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OAB symptoms for at least one month&#xD;
&#xD;
          -  &gt;20 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to mirabegron, urinary tract infections, unstable hypertension&#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_contact>
    <last_name>Sheng-Mou Hsiao, MD</last_name>
    <phone>+886289667000</phone>
    <phone_ext>1818</phone_ext>
    <email>smhsiao2@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sheng-Mou Hsiao, M.D.</last_name>
      <phone>+886-2-89667000</phone>
      <phone_ext>1424</phone_ext>
      <email>smhsiao2@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <results_reference>
    <citation>Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.</citation>
    <PMID>28714288</PMID>
  </results_reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Far Eastern Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Sheng-Mou Hsiao</investigator_full_name>
    <investigator_title>Chief, Department of Obstetrics &amp; Gynecology, Far Eastern Memorial Hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mirabegron</mesh_term>
  </intervention_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/NCT03251300
org study id: 106001-F
nct id: NCT03251300
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to elucidate whether night-time dosing of mirebegron can improve
      nocturia, compared with daytime dosing of mirabegron.
Background/Purpose: Women with overactive bladder syndrome (OAB) may have symptoms of
      nocturia, in addition to urgency and frequency. Women with nocturia are prone to suffer from
      a fall and fracture. Beta-3 agonist is an effective treatment for OAB. However, women with
      nocturia may need adjuvant desmopressin to improve nocturia. The aim of this study is to
      elucidate whether night-time dosing can improve nocturia, compared with daytime dosing.

      Patients and Methods: The investigators will perform a prospective randomized controlled
      trial to recruit 90 female OAB patients at the outpatient clinic of Department of Obstetrics
      and Gynecology of Far Eastern Memorial Hospital. All OAB women will be treated by mirabegron.
      All enrolled OAB women will be allocated to two groups (group A and B). The women in group A
      will receive daytime dosing of mirabegron treatment; and the women in group B will receive
      nighttime dosing of mirabegron. All OAB female patients will be asked to complete Urgency
      Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health
      questionnaires, 3-day bladder diary before, 4 weeks' and after 12 weeks' mirabegron
      treatment. STATA software is used for statistical analyses.

      Possible Results: The investigators can answer whether night-time dosing of mirabegron can
      improve nocturia, compared with daytime dosing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Nocturia episodes
time frame: 12 weeks
description: comparison of baseline and post-treatment nocturia episodes from bladder diary
measure: Severity of nocturia
time frame: 12 weeks
description: comparison of baseline and post-treatment severity of nocturia from questionnaires
arm group label: group A
arm group type: Experimental
description: daytime dosing of mirabegron
arm group label: group B
arm group type: Active Comparator
description: nighttime dosing of mirabegron
intervention type: Drug
intervention name: daytime dosing of mirabegron
description: All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
arm group label: group A
intervention type: Drug
intervention name: nighttime dosing of mirabegron
description: All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
arm group label: group B
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Sheng-Mou Hsiao, MD
phone: +886289667000
phone ext: 1818
email: smhsiao2@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Tsai KH, Hsiao SM, Lin HH. Tolterodine treatment of women with overactive bladder syndrome: Comparison of night-time and daytime dosing for nocturia. J Obstet Gynaecol Res. 2017 Nov;43(11):1719-1725. doi: 10.1111/jog.13438. Epub 2017 Jul 16.
PMID: 28714288
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief, Department of Obstetrics & Gynecology, Far Eastern Memorial Hospital
mesh term: Urinary Bladder, Overactive
mesh term: Syndrome
mesh term: Mirabegron