<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/NCT03829137</url>
  </required_header>
  <id_info>
    <org_study_id>201801679A3</org_study_id>
    <nct_id>NCT03829137</nct_id>
  </id_info>
  <brief_title>The Clinical Effects of Laser Acupuncture Therapy for OAB Women.</brief_title>
  <official_title>The Clinical Effects of Laser Acupuncture Therapy for OAB Women: a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence,&#xD;
      daytime frequency and nocturia. Urgency incontinence is more common in older women and may be&#xD;
      associated with comorbid conditions that occur with age. The standard OAB medical treatments&#xD;
      may induced several intolerable side effects including dry mouth, constipation, and so on,&#xD;
      therefore alternative therapies are often considered. Acupuncture had been proved effective&#xD;
      to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser&#xD;
      acupuncture has minimal side effects comparing to conventional acupuncture, but its effects&#xD;
      against OAB had never been examined. Experiments with laser acupuncture are expected to be&#xD;
      another way to relieve OAB symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects are treated with 7 acupoints which are localized according to WHO standardized&#xD;
      acupressure point location guideline. The patients lay in the supine position before&#xD;
      treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers &amp; Janssen GmbH,&#xD;
      Waldkirch, Germany) will be applied to each selected acupoints mentioned above. The&#xD;
      experimental group (verum laser acupuncture) and control group (sham laser acupuncture) will&#xD;
      receive laser acupuncture 3 times per week for 3 weeks, total of 9 sessions, based on&#xD;
      clinical experience (Treatment could be extended if necessary). The basic patient data will&#xD;
      be recorded at baseline and adverse effect will also be recorded during the clinical trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">April 5, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 5, 2022</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, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OAB symptom score (OABSS)</measure>
    <time_frame>3 weeks</time_frame>
    <description>This is a four symptoms questionnaire to quantify OAB symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Urogenital Distress Inventory (UDI-6)</measure>
    <time_frame>3 weeks</time_frame>
    <description>This evaluation scale assesses symptom distress.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incontinence Impact Questionnaire (IIQ-7)</measure>
    <time_frame>3 weeks</time_frame>
    <description>This evaluation scale assesses the impact on daily life of urinary incontinence.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Verum laser acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham laser acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham laser acupuncture (no laser output)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Verum laser acupuncture</intervention_name>
    <description>The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers &amp; Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints for 3 weeks, total of 9 sessions.</description>
    <arm_group_label>Verum laser acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham laser acupuncture</intervention_name>
    <description>The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.</description>
    <arm_group_label>Sham laser acupuncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women are older than 18 years old.&#xD;
&#xD;
          2. Participant is willing to sign the consent.&#xD;
&#xD;
          3. Women havea moderate OAB symptoms.&#xD;
&#xD;
          4. Total scores of OABSS &gt; 6 points and the 3rd question of OABSS &gt; 2 points.&#xD;
&#xD;
          5. Not using anticholinergic drugs for more than three weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with lower urinary tract infection.&#xD;
&#xD;
          2. Patients who cannot complete the questionnaire.&#xD;
&#xD;
          3. Patients who use Botox to inject bladder and pelvic floor muscles within one year.&#xD;
&#xD;
          4. Pregnant patients.&#xD;
&#xD;
          5. Patients who continue to have electrical stimulation and acupuncture in the legs,&#xD;
             waist and pelvis.&#xD;
&#xD;
          6. Patients with vaginal bleeding.&#xD;
&#xD;
          7. Other herbal and folklore therapies are being used to improve patients with overactive&#xD;
             bladder.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsin-Ning Chang</last_name>
    <role>Study Chair</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsin-Ning Chang</last_name>
    <phone>(02)24313131</phone>
    <phone_ext>2777</phone_ext>
    <email>8705015@cgmh.org.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsin-Ning Chang</last_name>
      <email>8705015@cgmh.org.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>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/NCT03829137
org study id: 201801679A3
nct id: NCT03829137
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Overactive bladder (OAB) is a syndrome causes urgency, with or without urgent incontinence,
      daytime frequency and nocturia. Urgency incontinence is more common in older women and may be
      associated with comorbid conditions that occur with age. The standard OAB medical treatments
      may induced several intolerable side effects including dry mouth, constipation, and so on,
      therefore alternative therapies are often considered. Acupuncture had been proved effective
      to OAB treatment, however, this invasive procedure also cause pain and hematoma. Laser
      acupuncture has minimal side effects comparing to conventional acupuncture, but its effects
      against OAB had never been examined. Experiments with laser acupuncture are expected to be
      another way to relieve OAB symptoms.
The subjects are treated with 7 acupoints which are localized according to WHO standardized
      acupressure point location guideline. The patients lay in the supine position before
      treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH,
      Waldkirch, Germany) will be applied to each selected acupoints mentioned above. The
      experimental group (verum laser acupuncture) and control group (sham laser acupuncture) will
      receive laser acupuncture 3 times per week for 3 weeks, total of 9 sessions, based on
      clinical experience (Treatment could be extended if necessary). The basic patient data will
      be recorded at baseline and adverse effect will also be recorded during the clinical trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: OAB symptom score (OABSS)
time frame: 3 weeks
description: This is a four symptoms questionnaire to quantify OAB symptoms.
measure: The Urogenital Distress Inventory (UDI-6)
time frame: 3 weeks
description: This evaluation scale assesses symptom distress.
measure: Incontinence Impact Questionnaire (IIQ-7)
time frame: 3 weeks
description: This evaluation scale assesses the impact on daily life of urinary incontinence.
arm group label: Verum laser acupuncture
arm group type: Experimental
description: Verum laser acupuncture：Low level laser therapy stimulates 7 acupuncture points on both sides of the body .
arm group label: Sham laser acupuncture
arm group type: Sham Comparator
description: sham laser acupuncture (no laser output)
intervention type: Device
intervention name: Verum laser acupuncture
description: The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints for 3 weeks, total of 9 sessions.
arm group label: Verum laser acupuncture
intervention type: Device
intervention name: Sham laser acupuncture
description: The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.
arm group label: Sham laser acupuncture
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hsin-Ning Chang
role: Study Chair
affiliation: Chang Gung Memorial Hospital
last name: Hsin-Ning Chang
phone: (02)24313131
phone ext: 2777
email: 8705015@cgmh.org.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
sharing ipd: No