xml: <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/NCT05968885</url>
    </required_header>
    <id_info>
      <org_study_id>22MMHIS039e</org_study_id>
      <nct_id>NCT05968885</nct_id>
    </id_info>
    <brief_title>Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity</brief_title>
    <official_title>Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mackay Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mackay Memorial Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To investigates the effects of botulinum toxin type A bladder injection compared to combined&#xD;
        pharmacotherapy with Mirabegron and Solifenacin.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with detrusor overactivity who were refractory to monotherapy with either&#xD;
        anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient&#xD;
        were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined&#xD;
        pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and&#xD;
        impact on quality of life were evaluated by short form of Urinary Distress Inventory,&#xD;
        (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score&#xD;
        (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary&#xD;
        incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at&#xD;
        first involuntary detrusor contraction and volume at first involuntary detrusor contraction&#xD;
        were measured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">October 1, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2025</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>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Short form of Urinary Distress Inventory (UDI-6)</measure>
      <time_frame>Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment</time_frame>
      <description>UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short form of Incontinence Impact Questionnaire (IIQ-7)</measure>
      <time_frame>Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment</time_frame>
      <description>The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships &amp; emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overactive Bladder Symptom Score (OABSS)</measure>
      <time_frame>Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment</time_frame>
      <description>The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maximum cystometric capacity</measure>
      <time_frame>Assess during 3 months - 1year after treatment</time_frame>
      <description>One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum detrusor pressure at first involuntary detrusor contraction</measure>
      <time_frame>Assess during 3 months - 1year after treatment</time_frame>
      <description>One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Volume at first involuntary detrusor contraction</measure>
      <time_frame>Assess during 3 months - 1year after treatment</time_frame>
      <description>One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Urinary Bladder, Overactive</condition>
    <condition>Urodynamics</condition>
    <condition>Effect of Drug</condition>
    <arm_group>
      <arm_group_label>Intradetrusor onabotulinumtoxinA injection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combination pharmacotherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Combine Mirabegron and Solifenacin.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Intradetrusor Botox® (onabotulinumtoxinA) injection</intervention_name>
      <description>The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.</description>
      <arm_group_label>Intradetrusor onabotulinumtoxinA injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Combine Mirabegron and Solifenacin.</intervention_name>
      <description>Combination pharmacotherapy</description>
      <arm_group_label>Combination pharmacotherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with detrusor overactivity which defined as a urodynamic observation&#xD;
               characterized by involuntary detrusor contractions during the filling phase. Those who&#xD;
               were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor&#xD;
               agonists were enrolled for prospective study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Postvoid urine retention before treatment&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>The study focus on female detrusor overactivity.</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hui-Hsuan Lau, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mackay Memorial Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui-Hsuan Lau, MD</last_name>
      <phone>+886-2-25433535</phone>
      <email>huihsuan1220@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mackay Memorial Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jiun Chyi Hwang, MD</last_name>
        <phone>+886-2-2543-3535</phone>
        <email>jiun1989@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <reference>
      <citation>Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.</citation>
      <PMID>31039103</PMID>
    </reference>
    <reference>
      <citation>Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.</citation>
      <PMID>30644570</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mackay Memorial Hospital</investigator_affiliation>
      <investigator_full_name>Hui-Hsuan Lau</investigator_full_name>
      <investigator_title>Head of urogynecology, Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Detrusor overactivity</keyword>
    <keyword>Urodynamic study</keyword>
    <keyword>Combined pharmacotherapy</keyword>
    <keyword>Botulinum Toxins</keyword>
    <keyword>Effectiveness</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Solifenacin Succinate</mesh_term>
      <mesh_term>Mirabegron</mesh_term>
      <mesh_term>Botulinum Toxins, Type A</mesh_term>
      <mesh_term>abobotulinumtoxinA</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968885
  org study id: 22MMHIS039e
  nct id: NCT05968885
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  To investigates the effects of botulinum toxin type A bladder injection compared to combined
        pharmacotherapy with Mirabegron and Solifenacin.
  Patients with detrusor overactivity who were refractory to monotherapy with either
        anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient
        were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined
        pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and
        impact on quality of life were evaluated by short form of Urinary Distress Inventory,
        (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score
        (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary
        incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at
        first involuntary detrusor contraction and volume at first involuntary detrusor contraction
        were measured.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: Short form of Urinary Distress Inventory (UDI-6)
  time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
  description: UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.
  measure: Short form of Incontinence Impact Questionnaire (IIQ-7)
  time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
  description: The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships & emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.
  measure: Overactive Bladder Symptom Score (OABSS)
  time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
  description: The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.
  measure: Maximum cystometric capacity
  time frame: Assess during 3 months - 1year after treatment
  description: One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
  measure: Maximum detrusor pressure at first involuntary detrusor contraction
  time frame: Assess during 3 months - 1year after treatment
  description: One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
  measure: Volume at first involuntary detrusor contraction
  time frame: Assess during 3 months - 1year after treatment
  description: One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
  arm group label: Intradetrusor onabotulinumtoxinA injection
  arm group type: Active Comparator
  description: The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
  arm group label: Combination pharmacotherapy
  arm group type: Experimental
  description: Combine Mirabegron and Solifenacin.
  intervention type: Procedure
  intervention name: Intradetrusor Botox® (onabotulinumtoxinA) injection
  description: The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
  arm group label: Intradetrusor onabotulinumtoxinA injection
  intervention type: Drug
  intervention name: Combine Mirabegron and Solifenacin.
  description: Combination pharmacotherapy
  arm group label: Combination pharmacotherapy
  criteria: 
  gender: Female
  gender based: Yes
  gender description: The study focus on female detrusor overactivity.
  minimum age: 20 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Hui-Hsuan Lau, MD
  role: Principal Investigator
  affiliation: Mackay Memorial Hospital
  last name: Hui-Hsuan Lau, MD
  phone: +886-2-25433535
  email: huihsuan1220@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  citation: Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
  PMID: 31039103
  citation: Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.
  PMID: 30644570
  responsible party type: Principal Investigator
  investigator affiliation: Mackay Memorial Hospital
  investigator full name: Hui-Hsuan Lau
  investigator title: Head of urogynecology, Associate Professor
  mesh term: Urinary Bladder, Overactive
  mesh term: Solifenacin Succinate
  mesh term: Mirabegron
  mesh term: Botulinum Toxins, Type A
  mesh term: abobotulinumtoxinA
  sharing ipd: No