<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/NCT04412876</url>
  </required_header>
  <id_info>
    <org_study_id>109017-F</org_study_id>
    <nct_id>NCT04412876</nct_id>
  </id_info>
  <brief_title>Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study</brief_title>
  <official_title>Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study</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>
    <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>
      To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological&#xD;
      distress, sexual function, bladder wall structure and blood flow in women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological&#xD;
      distress, sexual function, bladder wall structure and blood flow in women&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Failed to pass the Ministry of Science and Technology.&#xD;
  </why_stopped>
  <start_date type="Actual">May 31, 2020</start_date>
  <completion_date type="Actual">June 3, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2020</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the score of Urgency Severity Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of Urgency Severity Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the score of Overactive Bladder Symptom Score</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of Overactive Bladder Symptom Score</description>
  </other_outcome>
  <other_outcome>
    <measure>the score of King's health questionnaires</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of King's health questionnaires</description>
  </other_outcome>
  <other_outcome>
    <measure>the score of Brief symptom rating scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of Brief symptom rating scale</description>
  </other_outcome>
  <other_outcome>
    <measure>the score of Female sexual function index</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the score of Female sexual function index</description>
  </other_outcome>
  <other_outcome>
    <measure>Blood flow index of the bladder</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the changes of blood flow index of the bladder</description>
  </other_outcome>
  <other_outcome>
    <measure>Bladder wall thickness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Between-group difference in the changes of Bladder wall thickness</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Duloxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receive Duloxetine 30 mg treatment per day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imipramine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive Imipramine 25 mg treatment per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <description>Duloxetine 30 mg qd</description>
    <arm_group_label>Duloxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipramine</intervention_name>
    <description>Imipramine 25mg qd</description>
    <arm_group_label>Imipramine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Stress urinary incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Take monoamine oxidase&#xD;
&#xD;
          2. Myocardial infarction critical,cardiovascular insufficiency (such as room blocking,&#xD;
             arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive&#xD;
             heartbeat).&#xD;
&#xD;
          3. Allergy to duloxetine or imipramine&#xD;
&#xD;
          4. Uncontrolled angular glaucoma patients&#xD;
&#xD;
          5. Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital</name>
      <address>
        <city>Banqiao</city>
        <state>New Taipei</state>
        <zip>22050</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>August 14, 2022</last_update_submitted>
  <last_update_submitted_qc>August 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2022</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 of Department of Obstetrics &amp; Gynecology</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>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
    <mesh_term>Imipramine</mesh_term>
  </intervention_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/NCT04412876
org study id: 109017-F
nct id: NCT04412876
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological
      distress, sexual function, bladder wall structure and blood flow in women
To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological
      distress, sexual function, bladder wall structure and blood flow in women
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
time frame: 8 weeks
description: Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence
measure: the score of Urgency Severity Scale
time frame: 8 weeks
description: Between-group difference in the score of Urgency Severity Scale
measure: the score of Overactive Bladder Symptom Score
time frame: 8 weeks
description: Between-group difference in the score of Overactive Bladder Symptom Score
measure: the score of King's health questionnaires
time frame: 8 weeks
description: Between-group difference in the score of King's health questionnaires
measure: the score of Brief symptom rating scale
time frame: 8 weeks
description: Between-group difference in the score of Brief symptom rating scale
measure: the score of Female sexual function index
time frame: 8 weeks
description: Between-group difference in the score of Female sexual function index
measure: Blood flow index of the bladder
time frame: 8 weeks
description: Between-group difference in the changes of blood flow index of the bladder
measure: Bladder wall thickness
time frame: 8 weeks
description: Between-group difference in the changes of Bladder wall thickness
arm group label: Duloxetine
arm group type: Experimental
description: Receive Duloxetine 30 mg treatment per day
arm group label: Imipramine
arm group type: Active Comparator
description: Receive Imipramine 25 mg treatment per day
intervention type: Drug
intervention name: Duloxetine
description: Duloxetine 30 mg qd
arm group label: Duloxetine
intervention type: Drug
intervention name: Imipramine
description: Imipramine 25mg qd
arm group label: Imipramine
criteria: 
gender: Female
minimum age: 25 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Far Eastern Memorial Hospital
investigator full name: Sheng-Mou Hsiao
investigator title: Chief of Department of Obstetrics & Gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Duloxetine Hydrochloride
mesh term: Imipramine
sharing ipd: No