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/NCT05997992</url>
    </required_header>
    <id_info>
      <org_study_id>11-XD-071</org_study_id>
      <nct_id>NCT05997992</nct_id>
    </id_info>
    <brief_title>Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder</brief_title>
    <official_title>Clinical Efficacy Evaluation of Electroacupuncture as Adjuvant Therapy for Female Patients With Overactive Bladder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation</source>
    <oversight_info>
      <is_fda_regulated_drug>No</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>
        Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does&#xD;
        not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can&#xD;
        lead to psychological burdens, affect interpersonal relationships and reduce women's quality&#xD;
        of life.&#xD;
  &#xD;
        Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy,&#xD;
        neuromodulation, botulinum toxin therapy, and surgical intervention. At present,&#xD;
        anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of&#xD;
        dry mouth often lead to poor patient compliance.&#xD;
  &#xD;
        Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation&#xD;
        technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms&#xD;
        related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main&#xD;
        purpose of this study was to evaluate the specific acupoints in accordance with traditional&#xD;
        Chinese medicine theory in women with OAB under conventional Western medicine treatment to&#xD;
        evaluate the improvement of women's related urinary tract symptoms, quality of life and&#xD;
        autonomic nervous system function.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does&#xD;
        not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can&#xD;
        lead to psychological burdens, affect interpersonal relationships and reduce women's quality&#xD;
        of life.&#xD;
  &#xD;
        Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy,&#xD;
        neuromodulation, botulinum toxin therapy, and surgical intervention. At present,&#xD;
        anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of&#xD;
        dry mouth often lead to poor patient compliance.&#xD;
  &#xD;
        Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation&#xD;
        technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms&#xD;
        related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main&#xD;
        purpose of this study was to evaluate the specific acupoints in accordance with traditional&#xD;
        Chinese medicine theory in women with OAB under conventional Western medicine treatment to&#xD;
        evaluate the improvement of women's related urinary tract symptoms, quality of life and&#xD;
        autonomic nervous system function.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</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 research is a single-blind randomized controlled human trial.The research is a single-blind randomized controlled human trial. It is planned to select 100 women aged 20-80 years with a diagnosis of OAB in outpatient clinics, and divide them into an experimental group and a control group of 50 each. The experimental group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7); the control group received placebo acupuncture</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The research is a single-blind randomized controlled human trial.The participant will divide into control group or experimental group randomly by random number table.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Urinary tract related questionnair</measure>
      <time_frame>Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.</time_frame>
      <description>Measuring OAB scores to record the differ between two groups and time.Higher scores indicate more severe symptoms of overactive bladder syndrome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>King's Health Quality of Life Questionnaire(KHQ)</measure>
      <time_frame>Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.</time_frame>
      <description>Measuring KHQ scores to record the differ between two groups and time.Higher scores indicate more significant impact of bladder-related issues on quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Heart rate variability(HRV)</measure>
      <time_frame>Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.</time_frame>
      <description>Measuring HRV to record the differ between two groups and time.Whether the balance of the autonomic nervous system in HRV can also be used to infer the severity of OAB symptoms is also an observation target for the researchers.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Is the dose of the drug reduced?</measure>
      <time_frame>Every week will record the dose that participants take.A total of 8 weeks.</time_frame>
      <description>We record the doses of drugs that participants take.By comparing the differences in medication dosage over the course of 8 weeks, we aim to investigate the effectiveness of the therapeutic intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Are the side effects reduced?</measure>
      <time_frame>Every week will record side effects of taking medicine.A total of 8 weeks.</time_frame>
      <description>We record participants' side effects after taking the drug.By comparing the differences in side effects over the course of 8 weeks, we aim to explore the effectiveness of the therapeutic intervention.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Overactive Bladder</condition>
    <arm_group>
      <arm_group_label>Electroacupuncture group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Electroacupuncture group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7).20 minutes of acupuncture.&#xD;
  Twice a week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham acupuncture group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group received placebo acupuncture.Except for placebo acupuncture, which won't penetrate the skin, the rest is the same as the Electroacupuncture group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>electroacupuncture</intervention_name>
      <description>Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.</description>
      <arm_group_label>Electroacupuncture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham acupuncture</intervention_name>
      <description>Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.</description>
      <arm_group_label>Sham acupuncture group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patient aged 20-80 with overactive bladder.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient has history of cancer, stroke, or hyperthyroidism..&#xD;
  &#xD;
            -  Patient isn't willing to accept acupuncture or moxibustion treatment.&#xD;
  &#xD;
            -  Patient who is pregnant or plan to pregnant.&#xD;
  &#xD;
            -  Patient with urinary tract infection.&#xD;
  &#xD;
            -  Patient who had injection of botulinum toxin (Botox®), PTNS or SMN treatment before.&#xD;
  &#xD;
            -  Patient recieved acupuncture treatment before.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Buddhist Taipei Tzu Chi General Hospital</name>
        <address>
          <city>New Taipei City</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>H. C. Wu, MD.</last_name>
        <phone>+886266289009</phone>
        <email>xuang@tzuchi.com.tw</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Urge Incontinence</keyword>
    <keyword>Overactive bladder</keyword>
    <keyword>quality of life</keyword>
    <keyword>TCM constitution,</keyword>
    <keyword>Electroacupuncture</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
    </condition_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/NCT05997992
  org study id: 11-XD-071
  nct id: NCT05997992
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does
        not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can
        lead to psychological burdens, affect interpersonal relationships and reduce women's quality
        of life.
  
        Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy,
        neuromodulation, botulinum toxin therapy, and surgical intervention. At present,
        anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of
        dry mouth often lead to poor patient compliance.
  
        Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation
        technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms
        related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main
        purpose of this study was to evaluate the specific acupoints in accordance with traditional
        Chinese medicine theory in women with OAB under conventional Western medicine treatment to
        evaluate the improvement of women's related urinary tract symptoms, quality of life and
        autonomic nervous system function.
  Overactive bladder (OAB) is often accompanied by frequent urination and nocturia, and does
        not necessarily manifest as urge incontinence. Urgency to urinate and frequent urination can
        lead to psychological burdens, affect interpersonal relationships and reduce women's quality
        of life.
  
        Treatment of OAB includes lifestyle changes, behavioral therapy, drug therapy,
        neuromodulation, botulinum toxin therapy, and surgical intervention. At present,
        anticholinergic drugs are usually the first-line treatment for OAB, but the side effects of
        dry mouth often lead to poor patient compliance.
  
        Transcutaneous tibial nerve stimulation (PTNS) is a minimally invasive neuromodulation
        technique. Past studies have confirmed that PTNS has clinical efficacy in treating symptoms
        related to overactive bladder, while TCM's electroacupuncture is similar to PTNS. The main
        purpose of this study was to evaluate the specific acupoints in accordance with traditional
        Chinese medicine theory in women with OAB under conventional Western medicine treatment to
        evaluate the improvement of women's related urinary tract symptoms, quality of life and
        autonomic nervous system function.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The research is a single-blind randomized controlled human trial.The research is a single-blind randomized controlled human trial. It is planned to select 100 women aged 20-80 years with a diagnosis of OAB in outpatient clinics, and divide them into an experimental group and a control group of 50 each. The experimental group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7); the control group received placebo acupuncture
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The research is a single-blind randomized controlled human trial.The participant will divide into control group or experimental group randomly by random number table.
  measure: Urinary tract related questionnair
  time frame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
  description: Measuring OAB scores to record the differ between two groups and time.Higher scores indicate more severe symptoms of overactive bladder syndrome.
  measure: King's Health Quality of Life Questionnaire(KHQ)
  time frame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
  description: Measuring KHQ scores to record the differ between two groups and time.Higher scores indicate more significant impact of bladder-related issues on quality of life.
  measure: Heart rate variability(HRV)
  time frame: Study spans 8 weeks: initial data collection, biweekly collections, 1-week break after 6 weeks, final collection in week 8. 5 questionnaire rounds in total. Proposed timeline.
  description: Measuring HRV to record the differ between two groups and time.Whether the balance of the autonomic nervous system in HRV can also be used to infer the severity of OAB symptoms is also an observation target for the researchers.
  measure: Is the dose of the drug reduced?
  time frame: Every week will record the dose that participants take.A total of 8 weeks.
  description: We record the doses of drugs that participants take.By comparing the differences in medication dosage over the course of 8 weeks, we aim to investigate the effectiveness of the therapeutic intervention.
  measure: Are the side effects reduced?
  time frame: Every week will record side effects of taking medicine.A total of 8 weeks.
  description: We record participants' side effects after taking the drug.By comparing the differences in side effects over the course of 8 weeks, we aim to explore the effectiveness of the therapeutic intervention.
  arm group label: Electroacupuncture group
  arm group type: Experimental
  description: The Electroacupuncture group received electroacupuncture at Baihui(GV20), bilateral Sanyinjiao(SP-6) and Fuliu points(KP-7).20 minutes of acupuncture.
  Twice a week.
  arm group label: Sham acupuncture group
  arm group type: Placebo Comparator
  description: The control group received placebo acupuncture.Except for placebo acupuncture, which won't penetrate the skin, the rest is the same as the Electroacupuncture group.
  intervention type: Device
  intervention name: electroacupuncture
  description: Electroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.
  arm group label: Electroacupuncture group
  intervention type: Device
  intervention name: sham acupuncture
  description: Acupuncture does not penetrate the skin, and the electroacupuncture machine is not plugged in.
  arm group label: Sham acupuncture group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Urinary Bladder, Overactive