<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/NCT03260907</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0008</org_study_id>
    <nct_id>NCT03260907</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder</brief_title>
  <official_title>Efficacy and Safety of Electroacupuncture and Acupuncture in Postmenopausal Women With Overactive Bladder ; A Multicenter, Randomized, Controlled, Parallel Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DongGuk University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Korea Health Industry Development Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DongGuk University</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>
      The purpose of this study is to verify the efficacy and safety of electroacupuncture&#xD;
      treatment of postmenopausal women with overactive bladder (OAB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators targeted the patients of menopausal women with OAB. After treatment in 2&#xD;
      groups - electroacupuncture treatment and acupuncture treatment - the investigators will&#xD;
      compare the improvement of the urinary symptoms and the quality of life, and further the best&#xD;
      treatment method. In addition, the investigators are going to evaluate the safety of abnormal&#xD;
      reaction during the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3-day bladder diary change</measure>
    <time_frame>at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)</time_frame>
    <description>The daytime micturitions per 24 hr, nocturnal micturitions per 24 hr, total count of urgency (sum of urgency epi¬sodes defined as URS ≥ 3 for three days), total urgency score (sum of urgency score for three days), and total count of UUI (sum of UUI episodes for three days) is checked.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The overactive bladder symptom score (OABSS) change</measure>
    <time_frame>at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)</time_frame>
    <description>The OABSS consists of four questions regarding OAB symptoms; day¬time frequency, nocturia, urgency, and UUI. The sum of the four scores runs between 0 and 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The King's Health Questionnaire (KHQ)</measure>
    <time_frame>at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)</time_frame>
    <description>The KHQ is a urine questionnaire that can assess the severity of urination symptoms and evaluate the impact of urination symptoms on quality of life. This questionnaire is known to have reliability and validity in measuring the quality of life of patients with incontinence. The 10 domains from the KHQ evaluated are general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (AEs)</measure>
    <time_frame>at baseline, every treatment(12 sessions in 6 weeks, including after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)</time_frame>
    <description>Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">98</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Menopause</condition>
  <arm_group>
    <arm_group_label>Electroacupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group received electroacupuncture using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients in this group received acupuncture without electric stimulation using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electroacupuncture</intervention_name>
    <description>The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6~13.9mA).</description>
    <arm_group_label>Electroacupuncture</arm_group_label>
    <other_name>EA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acupuncture</intervention_name>
    <description>The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used.</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <other_name>AC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women over 40 years of age without the possibility of pregnancy&#xD;
&#xD;
          2. Have a history of amenorrhea for at least 1 year and have no previous history of&#xD;
             hormone replacement therapy for the last 6 months&#xD;
&#xD;
          3. With symptoms of urinary frequency and urgency lasting more than three months&#xD;
&#xD;
          4. Who fit the diagnostic criteria for OAB, with a total score more than three points in&#xD;
             Korean version overactive bladder symptom score (OABSS)&#xD;
&#xD;
          5. Who have average urinary frequency of more than eight times per day and urgency which&#xD;
             is defined as urgency rating scale (URS) on bladder diary is more than two points&#xD;
             and/or UUI on 3-day bladder diary during one week screening period&#xD;
&#xD;
          6. Who agree to this clinical study after sufficient explanation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diag¬nosed with UTI by urine examination&#xD;
&#xD;
          2. With stress urinary incontinence without symptoms of OAB&#xD;
&#xD;
          3. With suspected of having voiding dys¬function induced by neurological damage&#xD;
&#xD;
          4. With a medical history of cystocele, uterine pro¬lapse or similar&#xD;
&#xD;
          5. With a medical history of obstructive uropathy such as urinary stones and urinary&#xD;
             tumors&#xD;
&#xD;
          6. With a surgical history of urethra or bladder&#xD;
&#xD;
          7. With a medical history of malignant tumors of urinary tract&#xD;
&#xD;
          8. With a medical history of neurologic disease or psychi¬atric illness&#xD;
&#xD;
          9. Have an artificial cardiac pacemaker or implantable cardioverter defibrillator in the&#xD;
             chest&#xD;
&#xD;
         10. Have experienced a hypersensitivity reaction after an acupuncture treatment, or show&#xD;
             any other contraindications;&#xD;
&#xD;
         11. Who participated in another clinical trial within the past three months&#xD;
&#xD;
         12. Who have taken therapeutic drugs that may affect blad¬der function within one month of&#xD;
             the start of this study&#xD;
&#xD;
         13. With inadequate literacy to complete study documents&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eun Young Nam, Ph.D</last_name>
    <phone>+82-31-710-3725</phone>
    <email>obgyney@naver.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dong Il Kim, Ph.D</last_name>
    <phone>+82-31-961-9062</phone>
    <email>obgykdi@naver.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dongguk university Bundang Oriental Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>13601</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Eun Young Nam, Ph.D</last_name>
      <phone>+82-31-710-3725</phone>
      <email>obgyney@naver.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>DongGuk University</investigator_affiliation>
    <investigator_full_name>Jung Seunghyun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Overactive bladder</keyword>
  <keyword>menopause</keyword>
  <keyword>Postmenopausal overactive bladder</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03260907
org study id: 2017-0008
nct id: NCT03260907
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to verify the efficacy and safety of electroacupuncture
      treatment of postmenopausal women with overactive bladder (OAB).
The investigators targeted the patients of menopausal women with OAB. After treatment in 2
      groups - electroacupuncture treatment and acupuncture treatment - the investigators will
      compare the improvement of the urinary symptoms and the quality of life, and further the best
      treatment method. In addition, the investigators are going to evaluate the safety of abnormal
      reaction during the treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 3-day bladder diary change
time frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
description: The daytime micturitions per 24 hr, nocturnal micturitions per 24 hr, total count of urgency (sum of urgency epi¬sodes defined as URS ≥ 3 for three days), total urgency score (sum of urgency score for three days), and total count of UUI (sum of UUI episodes for three days) is checked.
measure: The overactive bladder symptom score (OABSS) change
time frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
description: The OABSS consists of four questions regarding OAB symptoms; day¬time frequency, nocturia, urgency, and UUI. The sum of the four scores runs between 0 and 15.
measure: The King's Health Questionnaire (KHQ)
time frame: at baseline, after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
description: The KHQ is a urine questionnaire that can assess the severity of urination symptoms and evaluate the impact of urination symptoms on quality of life. This questionnaire is known to have reliability and validity in measuring the quality of life of patients with incontinence. The 10 domains from the KHQ evaluated are general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity measures, and symptom severity.
measure: Adverse events (AEs)
time frame: at baseline, every treatment(12 sessions in 6 weeks, including after 6 weeks of treatment (the end of the treatment period), after 10 weeks of treatment(follow up evaluation)
description: Adverse events (AEs) indicate undesirable and unintentional signs, symptoms, or diseases that develop after intervention during the period of a clinical trial.
arm group label: Electroacupuncture
arm group type: Experimental
description: The patients in this group received electroacupuncture using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.
arm group label: Acupuncture
arm group type: Experimental
description: The patients in this group received acupuncture without electric stimulation using the same acupuncture points prescribed by a certified Korean Medicine Doctor with more than 6 years of oriental medicine college education and 1 years of clinical experience.
intervention type: Procedure
intervention name: Electroacupuncture
description: The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6~13.9mA).
arm group label: Electroacupuncture
other name: EA
intervention type: Procedure
intervention name: Acupuncture
description: The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used.
arm group label: Acupuncture
other name: AC
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Eun Young Nam, Ph.D
phone: +82-31-710-3725
email: obgyney@naver.com
last name: Dong Il Kim, Ph.D
phone: +82-31-961-9062
email: obgykdi@naver.com
facility: 
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: DongGuk University
investigator full name: Jung Seunghyun
investigator title: Principal Investigator
mesh term: Urinary Bladder, Overactive
sharing ipd: Undecided