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/NCT05997043</url>
    </required_header>
    <id_info>
      <org_study_id>2022-KY-301-02</org_study_id>
      <nct_id>NCT05997043</nct_id>
    </id_info>
    <brief_title>Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease</brief_title>
    <official_title>Safety and Efficacy of Botulinum Toxin A for Treatment of Overactive Bladder in Parkinson's Disease:Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhujiang Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhujiang Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        A randomized controlled trial is to be conducted to confirm the efficacy and safety of&#xD;
        intramuscular injection of botulinum toxin in the treatment of Parkinson's bladder&#xD;
        overactivity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Overactive bladder is defined by the International Continence Society as a syndrome&#xD;
        characterized by symptoms of urinary urgency, often accompanied by frequency and nocturia,&#xD;
        with or without urge incontinence, but without urinary tract infection or other definite&#xD;
        symptoms pathological changes.&#xD;
  &#xD;
        Bladder dysfunction is one of the most common autonomic nervous disorders in Parkinson's&#xD;
        disease (PD). Up to 70% of PD patients have bladder hyperactivity. Nocturia is the most&#xD;
        commonly reported symptom , followed by urinary frequency, urinary urgency and urge&#xD;
        incontinence, affecting patients' quality of life and social life.&#xD;
  &#xD;
        At present, intramuscular injection of 100U botulinum toxin (BoNT-A) is a reasonable choice&#xD;
        for the treatment of bladder overactivity in PD, and it has been proved to be a safe and&#xD;
        effective method for the treatment of neurogenic detrusor overactivity, especially for&#xD;
        patients with insufficient response to anticholinergic drugs,which is a Grade Ia&#xD;
        recommendation in the EAU guidelines.&#xD;
  &#xD;
        There are some problems in the current research as follows: 1. Single-arm study,&#xD;
        non-randomized control, and small sample size; 2. Only patients with urinary incontinence but&#xD;
        not patients with dry bladder overactivity were included; 3. Patients with urinary retention&#xD;
        are not excluded, resulting in urinary retention after injection of botulinum toxin,&#xD;
        affecting the experience of patients; 4. Botulinum toxin dose injection varies, there is&#xD;
        still a lack of large-scale prospective clinical studies to reflect the relationship between&#xD;
        botulinum toxin dose and residual urine volume; 5. The urodynamic index was used in the&#xD;
        outcome index, which could not reflect the improvement of symptoms sensitively and&#xD;
        objectively. In order to make up for the shortcomings of previous studies, a randomized&#xD;
        controlled trial is planned to confirm the efficacy and safety of intramuscular injection of&#xD;
        low dose botulinum toxin in the treatment of PD bladder overactivity&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 26, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</primary_completion_date>
    <phase>Early Phase 1</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>
      <intervention_model_description>The intervention group was given oral anti-Parkinson's drugs and Botox injection, while the control group was given only anti-Parkinson's drugs.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>For Parkinson's disease patients with overactive bladder, participants were assigned to an experimental or control group in a 1:1 ratio at the end of the baseline visit.Assignment will be concealed (sealed envelopes) and randomized to either the experimental or control group using an independent online computerized randomization system. Once randomized into the study, all patients will be included in the ITT analysis</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Symptom score of overactive bladder</measure>
      <time_frame>2 weeks,1month,2 month, 3 month</time_frame>
      <description>The purpose of this questionnaire is to assess the severity of symptoms in patients with overactive bladder. Based on the OABSS scale, when the score of question 3 (urgency) is more than 2 points, and the whole OABSS score is more than 3 points, it can be diagnosed as OAB</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>urinary symptoms</measure>
      <time_frame>2 weeks,1month,2 month, 3 month</time_frame>
      <description>frequency、urgency、noturia and urge incontinence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>urodynamics</measure>
      <time_frame>2 weeks,1month,2 month, 3 month</time_frame>
      <description>first sensation、first desire to void、strong desire to void、maximum bladder capacity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>King health score</measure>
      <time_frame>2 weeks,1month,2 month, 3 month</time_frame>
      <description>This questionnaire contains 9 areas, of which the general perception of health (GHP) and the severity of urination problems (SUP) contain only one problem, and the other 7 areas each contain multiple problems. The seven areas were behavioral limitation (RL), social limitation (SL), movement limitation (PL), personal life (PR), emotion (EMO), sleep / energy (SE) and urinary incontinence coping style (CM).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Urgency severity scale</measure>
      <time_frame>2 weeks,1month,2 month, 3 month</time_frame>
      <description>This questionnaire evaluates the degree of urination urgency. It is divided into 5 grades from 0 to 4, which are no sense of urgency, slight sense of urgency, moderate urgency, severe urgency and leakage.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Parkinson's Disease</condition>
    <condition>Overactive Bladder</condition>
    <condition>Onabotulinumtoxin A</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Control group</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>oral anti-Parkinson drugs and injection of botulinum toxin</intervention_name>
      <description>The experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>oral anti-Parkinson's drugs</intervention_name>
      <description>The control group only took oral anti-Parkinson's drugs.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. patients with idiopathic Parkinson's disease were diagnosed by experienced&#xD;
               neurologists based on the diagnostic criteria of the International Motor Disorder&#xD;
               Association.&#xD;
  &#xD;
            2. PD patients with overactive bladder were observed by voiding diary for 3 days and&#xD;
               evaluated by OABSS score.&#xD;
  &#xD;
            3. Eligible males and females, aged between 25 and 80.&#xD;
  &#xD;
            4. The patient was treated with dopaminergic drugs, and if there was an wearing-off&#xD;
               phenomenon, it was evaluated during the turning-off period or without taking the drug&#xD;
               (when the patient developed one of the symptoms in WOQ-19 [13] and the symptom&#xD;
               improved after the next medication, it suggested that there was an end-of-dose&#xD;
               phenomenon).&#xD;
  &#xD;
            5. With a history of NDO ≥ 3 months, the symptoms of bladder overactivity were not fully&#xD;
               controlled by anticholinergic drugs, which was defined as insufficient response after&#xD;
               4 weeks of treatment or unbearable side effects after 2 weeks of optimized dose&#xD;
               treatment.&#xD;
  &#xD;
            6. patients who took anticholinergic drugs at baseline must maintain a stable dose&#xD;
               throughout the study, while those who did not take anticholinergic drugs could not&#xD;
               take them during the study period.&#xD;
  &#xD;
            7. if necessary, the patient must be willing to initiate intermittent catheterization&#xD;
               (CIC).&#xD;
  &#xD;
            8. the informed consent of the subject or his guardian has been obtained, and the&#xD;
               informed consent of the clinical trial has been signed voluntarily.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1) Ultrasonography showed that the residual urine of bladder was larger than 10ml. 2)&#xD;
          Patients with glaucoma and myasthenia gravis are not suitable for botulinum toxin.&#xD;
  &#xD;
          3) Indwelling catheter or intermittent catheterization (CIC) is needed to empty the&#xD;
          bladder.&#xD;
  &#xD;
          4) Patients have been treated with botulinum toxin for any urinary disease. 5) People who&#xD;
          are known to be allergic or allergic to drugs and their ingredients 6) Take drugs that&#xD;
          interfere with neuromuscular transmission. 7) Receiving anticoagulant therapy. 8) There is&#xD;
          infection at the injection site. 9)With dementia, Parkinson's dementia scale ≤ 73.5 at&#xD;
          screening time [15] or with Parkinson's disease psychiatric disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shuzhen Zhu, Doctor</last_name>
      <role>Study Director</role>
      <affiliation>Zhujiang Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shuzhen Zhu, Doctor</last_name>
      <phone>13719153239</phone>
      <email>453951712@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shujuan Yang</last_name>
      <phone>13715657964</phone>
      <email>ysjky266@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Zhujiang Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>shuzhen zhu</last_name>
        <phone>86-020-783071</phone>
        <email>453951712@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhujiang Hospital</investigator_affiliation>
      <investigator_full_name>Shuzhen Zhu</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Antiparkinson Agents</mesh_term>
      <mesh_term>Botulinum Toxins</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05997043
  org study id: 2022-KY-301-02
  nct id: NCT05997043
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  A randomized controlled trial is to be conducted to confirm the efficacy and safety of
        intramuscular injection of botulinum toxin in the treatment of Parkinson's bladder
        overactivity.
  Overactive bladder is defined by the International Continence Society as a syndrome
        characterized by symptoms of urinary urgency, often accompanied by frequency and nocturia,
        with or without urge incontinence, but without urinary tract infection or other definite
        symptoms pathological changes.
  
        Bladder dysfunction is one of the most common autonomic nervous disorders in Parkinson's
        disease (PD). Up to 70% of PD patients have bladder hyperactivity. Nocturia is the most
        commonly reported symptom , followed by urinary frequency, urinary urgency and urge
        incontinence, affecting patients' quality of life and social life.
  
        At present, intramuscular injection of 100U botulinum toxin (BoNT-A) is a reasonable choice
        for the treatment of bladder overactivity in PD, and it has been proved to be a safe and
        effective method for the treatment of neurogenic detrusor overactivity, especially for
        patients with insufficient response to anticholinergic drugs,which is a Grade Ia
        recommendation in the EAU guidelines.
  
        There are some problems in the current research as follows: 1. Single-arm study,
        non-randomized control, and small sample size; 2. Only patients with urinary incontinence but
        not patients with dry bladder overactivity were included; 3. Patients with urinary retention
        are not excluded, resulting in urinary retention after injection of botulinum toxin,
        affecting the experience of patients; 4. Botulinum toxin dose injection varies, there is
        still a lack of large-scale prospective clinical studies to reflect the relationship between
        botulinum toxin dose and residual urine volume; 5. The urodynamic index was used in the
        outcome index, which could not reflect the improvement of symptoms sensitively and
        objectively. In order to make up for the shortcomings of previous studies, a randomized
        controlled trial is planned to confirm the efficacy and safety of intramuscular injection of
        low dose botulinum toxin in the treatment of PD bladder overactivity
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The intervention group was given oral anti-Parkinson's drugs and Botox injection, while the control group was given only anti-Parkinson's drugs.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: For Parkinson's disease patients with overactive bladder, participants were assigned to an experimental or control group in a 1:1 ratio at the end of the baseline visit.Assignment will be concealed (sealed envelopes) and randomized to either the experimental or control group using an independent online computerized randomization system. Once randomized into the study, all patients will be included in the ITT analysis
  measure: Symptom score of overactive bladder
  time frame: 2 weeks,1month,2 month, 3 month
  description: The purpose of this questionnaire is to assess the severity of symptoms in patients with overactive bladder. Based on the OABSS scale, when the score of question 3 (urgency) is more than 2 points, and the whole OABSS score is more than 3 points, it can be diagnosed as OAB
  measure: urinary symptoms
  time frame: 2 weeks,1month,2 month, 3 month
  description: frequency、urgency、noturia and urge incontinence
  measure: urodynamics
  time frame: 2 weeks,1month,2 month, 3 month
  description: first sensation、first desire to void、strong desire to void、maximum bladder capacity
  measure: King health score
  time frame: 2 weeks,1month,2 month, 3 month
  description: This questionnaire contains 9 areas, of which the general perception of health (GHP) and the severity of urination problems (SUP) contain only one problem, and the other 7 areas each contain multiple problems. The seven areas were behavioral limitation (RL), social limitation (SL), movement limitation (PL), personal life (PR), emotion (EMO), sleep / energy (SE) and urinary incontinence coping style (CM).
  measure: Urgency severity scale
  time frame: 2 weeks,1month,2 month, 3 month
  description: This questionnaire evaluates the degree of urination urgency. It is divided into 5 grades from 0 to 4, which are no sense of urgency, slight sense of urgency, moderate urgency, severe urgency and leakage.
  arm group label: Experimental group
  arm group type: Experimental
  description: Experimental group
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Control group
  intervention type: Drug
  intervention name: oral anti-Parkinson drugs and injection of botulinum toxin
  description: The experimental group was treated with oral anti-Parkinson drugs and injection of botulinum toxin
  arm group label: Experimental group
  intervention type: Drug
  intervention name: oral anti-Parkinson's drugs
  description: The control group only took oral anti-Parkinson's drugs.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Shuzhen Zhu, Doctor
  role: Study Director
  affiliation: Zhujiang Hospital
  last name: Shuzhen Zhu, Doctor
  phone: 13719153239
  email: 453951712@qq.com
  last name: Shujuan Yang
  phone: 13715657964
  email: ysjky266@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhujiang Hospital
  investigator full name: Shuzhen Zhu
  investigator title: Deputy Chief Physician
  mesh term: Parkinson Disease
  mesh term: Urinary Bladder, Overactive
  mesh term: Antiparkinson Agents
  mesh term: Botulinum Toxins