<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/NCT02980328</url>
  </required_header>
  <id_info>
    <org_study_id>E-1601/330-002</org_study_id>
    <nct_id>NCT02980328</nct_id>
  </id_info>
  <brief_title>Low-level Light Therapy for Overactive Bladder and Urinary Incontinence</brief_title>
  <official_title>Double-blind, Randomized, Shame-controlled Multicenter Clinical Study to Evaluate Efficacy and Safety of Low-level Light Therapy Device(Color DNA-WSF) for the Treatment of Overactive Bladder and Urinary Incontinence in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive&#xD;
      low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary&#xD;
      Incontinence (UI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: This was a prospective, randomized, double-blind, placebo-controlled,&#xD;
      multi-centered trial carried out at two university hospitals. This clinical trial was&#xD;
      approved by the Korea Food and Drug Administration and the Institutional Review Boards of the&#xD;
      two hospitals.&#xD;
&#xD;
      Study process:&#xD;
&#xD;
      All patients gave informed written consent after being informed of the details of the study.&#xD;
      Participants were randomized into either the LLLT or placebo control groups at the third&#xD;
      visit. All participants underwent demographic and history taking, a physical examination,&#xD;
      bladder examination and laboratory tests. All participants were educated on how to use the&#xD;
      device by demonstration and a picture-guided user manual.&#xD;
&#xD;
      During the second visit, the participants conducted a self-evaluation of frequency of urgency&#xD;
      urinary incontinence episode using the OABSS scale and underwent urine examination&#xD;
      (pre-treatment measurement). The third visit occurred 7 days from the date of the second&#xD;
      visit, and a clinical primary nurse described how to use the medical equipment and devices&#xD;
      when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and&#xD;
      IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way&#xD;
      at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo&#xD;
      examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment&#xD;
      measurement).&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      All data are summarized as means ± standard deviation or as numbers with proportions. A p &lt;&#xD;
      0.05 was considered to indicate significance. The investigator decided that the therapeutic&#xD;
      effect would be a &gt; 20% reduction in the frequency of urgency urinary incontinence episodes&#xD;
      after treatment. The statistical analysis was conducted using the self-reported micturition&#xD;
      diary after the 12 week visit as the primary endpoint. The investigator used an independent&#xD;
      t-test or Wilcoxon rank sum test depending on the normality of the data to evaluate&#xD;
      differences in each group between frequency of urgency urinary incontinence episodes measured&#xD;
      after the 12 week visit and baseline values. To test for normality, the investigator&#xD;
      performed Shapiro-Wilk's test. The examination of the ratio difference in nominal variable&#xD;
      was carried out using chi-square test or Fisher's exact test. A per-protocol (PP) and intent&#xD;
      to treat (ITT) analyses were used in our clinical trial to assess efficacy and safety. A Last&#xD;
      observation carried forward (LOCF) method was used for ITT analysis missing data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 3</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of urinary incontinence episode</measure>
    <time_frame>within 12 weeks after treatment</time_frame>
    <description>The primary outcome was frequency of urgency urinary incontinence episode based on the self-evaluated micturition diary measuring the difference between urgency urinary incontinence episode count pre and post-treatment. Urgency urinary incontinence episode was measured by the mean of 3 days report prior to the visit (week 0, 4 and 12). The higher values represent a worse outcome. All data collected by self-reported sheet. The participants conducted a self-evaluation of frequency of urgency urinary incontinence episode from 3 days prior to the visits and submitted to the investigator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of life</measure>
    <time_frame>within 12 weeks after treatment</time_frame>
    <description>The secondary outcome measures was quality of life, assessed by UDI-6 and IIQ-7. The UDI-6 descriptive system comprises the following 6 dimensions: bladder stimulation (2), stress-related urinary incontinence (2), obstructive disorder and pain. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to UDI-6 equation formula. The higher values represent a worse outcome. The IIQ-7 descriptive system comprises the following 7 dimensions: physical activity (2), travelling (2), social activity and psychological effect (2). Each dimension has 3 levels: no problems, some problems, extreme problems, and the score was calculated by multiplying 33 to the score (maximum 100). The subscales combined to compute a total score according to IIQ-7 equation formula.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>LLLT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo-controlled group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low-level light therapy</intervention_name>
    <description>we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.</description>
    <arm_group_label>LLLT group</arm_group_label>
    <other_name>Color DNA-WSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.</description>
    <arm_group_label>Placebo-controlled group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of overactive bladder or urinary incontinence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of taking medication for urgency urinary incontinence,&#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>Yong Beom Kim, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yong Beom Kim, Professor</last_name>
    <phone>+82 31 787</phone>
    <phone_ext>7253</phone_ext>
    <email>Ybkimlh@snubh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National Univesity Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Kyeonggi-do</state>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Dong Hun Suh, PhD</last_name>
      <phone>+82 31 787</phone>
      <phone_ext>7263</phone_ext>
      <email>sdhwcj@naver.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07985</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Sarah Lee, PhD</last_name>
      <phone>+82 2 2650</phone>
      <phone_ext>6011</phone_ext>
      <email>sarahmd@ewha.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Overactive bladder</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Low-level light therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02980328
org study id: E-1601/330-002
nct id: NCT02980328
lead sponsor: 
This study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive
      low-level light therapy (LLLT) in females with Overactive Bladder (OAB) and Urinary
      Incontinence (UI)
Study design: This was a prospective, randomized, double-blind, placebo-controlled,
      multi-centered trial carried out at two university hospitals. This clinical trial was
      approved by the Korea Food and Drug Administration and the Institutional Review Boards of the
      two hospitals.

      Study process:

      All patients gave informed written consent after being informed of the details of the study.
      Participants were randomized into either the LLLT or placebo control groups at the third
      visit. All participants underwent demographic and history taking, a physical examination,
      bladder examination and laboratory tests. All participants were educated on how to use the
      device by demonstration and a picture-guided user manual.

      During the second visit, the participants conducted a self-evaluation of frequency of urgency
      urinary incontinence episode using the OABSS scale and underwent urine examination
      (pre-treatment measurement). The third visit occurred 7 days from the date of the second
      visit, and a clinical primary nurse described how to use the medical equipment and devices
      when they were at home. All subjects filled out self-reported diary and filled out UDI-6 and
      IIQ-7 questionnaires in each visit. Subjects carried out the self-treatment in the same way
      at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo
      examination and filled out OABSS, UDI-6 and IIQ-7 questionnaires (post-treatment
      measurement).

      Statistical analysis:

      All data are summarized as means ± standard deviation or as numbers with proportions. A p <
      0.05 was considered to indicate significance. The investigator decided that the therapeutic
      effect would be a > 20% reduction in the frequency of urgency urinary incontinence episodes
      after treatment. The statistical analysis was conducted using the self-reported micturition
      diary after the 12 week visit as the primary endpoint. The investigator used an independent
      t-test or Wilcoxon rank sum test depending on the normality of the data to evaluate
      differences in each group between frequency of urgency urinary incontinence episodes measured
      after the 12 week visit and baseline values. To test for normality, the investigator
      performed Shapiro-Wilk's test. The examination of the ratio difference in nominal variable
      was carried out using chi-square test or Fisher's exact test. A per-protocol (PP) and intent
      to treat (ITT) analyses were used in our clinical trial to assess efficacy and safety. A Last
      observation carried forward (LOCF) method was used for ITT analysis missing data.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Frequency of urinary incontinence episode
time frame: within 12 weeks after treatment
description: The primary outcome was frequency of urgency urinary incontinence episode based on the self-evaluated micturition diary measuring the difference between urgency urinary incontinence episode count pre and post-treatment. Urgency urinary incontinence episode was measured by the mean of 3 days report prior to the visit (week 0, 4 and 12). The higher values represent a worse outcome. All data collected by self-reported sheet. The participants conducted a self-evaluation of frequency of urgency urinary incontinence episode from 3 days prior to the visits and submitted to the investigator.
measure: Changes in Quality of life
time frame: within 12 weeks after treatment
description: The secondary outcome measures was quality of life, assessed by UDI-6 and IIQ-7. The UDI-6 descriptive system comprises the following 6 dimensions: bladder stimulation (2), stress-related urinary incontinence (2), obstructive disorder and pain. Each dimension has 3 levels: no problems, some problems, extreme problems. The subscales combined to compute a total score according to UDI-6 equation formula. The higher values represent a worse outcome. The IIQ-7 descriptive system comprises the following 7 dimensions: physical activity (2), travelling (2), social activity and psychological effect (2). Each dimension has 3 levels: no problems, some problems, extreme problems, and the score was calculated by multiplying 33 to the score (maximum 100). The subscales combined to compute a total score according to IIQ-7 equation formula.
arm group label: LLLT group
arm group type: Experimental
description: Low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each
arm group label: Placebo-controlled group
arm group type: Placebo Comparator
description: Placebo low-level light therapy (LLLT) was self-performed for 12 weeks, 3 times a day for 20 minutes each. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.
intervention type: Device
intervention name: Low-level light therapy
description: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
arm group label: LLLT group
other name: Color DNA-WSF
intervention type: Device
intervention name: Placebo
description: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
arm group label: Placebo-controlled group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yong Beom Kim, Professor
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Yong Beom Kim, Professor
phone: +82 31 787
phone ext: 7253
email: Ybkimlh@snubh.org
facility: 
contact: 
facility: 
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Bladder, Overactive