<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/NCT03817203</url>
  </required_header>
  <id_info>
    <org_study_id>2018/08/05</org_study_id>
    <nct_id>NCT03817203</nct_id>
  </id_info>
  <brief_title>Effects of Kinesio Taping Application in Women With Overactive Bladder</brief_title>
  <official_title>Assistant Professor, Physioterapist, PhD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ataturk Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ataturk Training and Research 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>
      The aim of this study is to compare the effects of kinesio tape application on bladder&#xD;
      symptoms and quality of life in women with overactive bladder (OAB).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8</measure>
    <time_frame>Change from baseline bladder symptoms at 6 weeks</time_frame>
    <description>Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks.&#xD;
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urgency complaint assessed with the Perception of Intensity of Urgency Scale</measure>
    <time_frame>Change from baseline urgency complaints at 6 weeks</time_frame>
    <description>The patient's Perception of Intensity of Urgency Scale assessing urgency complaints will be used. This scale is scored on 0 and 4 points (the best score is '0' and the worst score is '4') based on urgency complaints. Higher scores indicate more severe urgency complaints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily urinary frequency measured with voiding diary</measure>
    <time_frame>Change from baseline the average daily urinary frequency at 6 weeks</time_frame>
    <description>Patients will be also instructed to keep voiding diary for three days. In this diary, the average daily urinary frequency will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of nocturia measured with voiding diary</measure>
    <time_frame>Change from baseline the average number of nocturia at 6 weeks</time_frame>
    <description>Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of nocturia will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of urinary incontinence measured with voiding diary</measure>
    <time_frame>Change from baseline the average number of urinary incontinence at 6 weeks</time_frame>
    <description>Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of urinary incontinence will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pelvic floor muscle strength measured with Modified Oxford Grading scale</measure>
    <time_frame>Change from baseline pelvic floor muscle strength at 6 weeks</time_frame>
    <description>The modified Oxford Grading Scale quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life assessed with King's Health Questionnaire (KHQ)</measure>
    <time_frame>Change from baseline quality of life at 6 weeks</time_frame>
    <description>King's Health Questionnaire assessing quality of life related to urinary problems will be used. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Overactive Bladder Syndrome</condition>
  <arm_group>
    <arm_group_label>Kinesio tape group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Kinesio tape application and pelvic floor exercise have been applied</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham kinesio tape application and pelvic floor exercise have been applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kinesio tape application</intervention_name>
    <description>Kinesio tape application combined with pelvic floor exercises will be performed.Taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks</description>
    <arm_group_label>Kinesio tape group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham tape application</intervention_name>
    <description>Sham tape application combined with pelvic floor exercises will be performed.Sham taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 to 65 years of age,&#xD;
&#xD;
          -  having overactive bladder&#xD;
&#xD;
          -  being volunteer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  only stress incontinence,&#xD;
&#xD;
          -  the presence of a malignant condition with a history of acute infection,&#xD;
&#xD;
          -  having a mental problem to prevent co-morbidity, evaluation and cooperative&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seyda TOPRAK CELENAY</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ankara Yildirim Beyazıt University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zehra Korkut</last_name>
    <role>Study Chair</role>
    <affiliation>KTO Karatay University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kemal Oskay</last_name>
    <role>Study Chair</role>
    <affiliation>Ankara Gazi Mustafa Kemal Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Seyda TOPRAK CELENAY</last_name>
    <phone>+90-534-041-3986</phone>
    <email>sydtoprak@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zehra KORKUT</last_name>
    <phone>+90-507-614-70-80</phone>
    <email>zehrakorkut85@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ankara Gazi Mustafa Kemal Hospital</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zehra Korkut</last_name>
      <phone>+90 507 614 70 80</phone>
      <email>zehrakorkut85@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 20, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ataturk Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Seyda TOPRAK CELENAY</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>


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/NCT03817203
org study id: 2018/08/05
nct id: NCT03817203
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the effects of kinesio tape application on bladder
      symptoms and quality of life in women with overactive bladder (OAB).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The severity of overactive bladder symptoms assessed with Overactive Bladder Questionnaire_V8
time frame: Change from baseline bladder symptoms at 6 weeks
description: Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society, referring to the previous four weeks.
Overactive Bladder Questionnaire_V8 assessing severity of overactive bladder symptoms will be used. This scale includes items on urgency, incontinence, nocturia and voiding frequency, as defined by the International Continence Society. The final score is the sum of the partial scores obtained for each of the eight questions, ranging from 0 to 40.
measure: Urgency complaint assessed with the Perception of Intensity of Urgency Scale
time frame: Change from baseline urgency complaints at 6 weeks
description: The patient's Perception of Intensity of Urgency Scale assessing urgency complaints will be used. This scale is scored on 0 and 4 points (the best score is '0' and the worst score is '4') based on urgency complaints. Higher scores indicate more severe urgency complaints.
measure: Daily urinary frequency measured with voiding diary
time frame: Change from baseline the average daily urinary frequency at 6 weeks
description: Patients will be also instructed to keep voiding diary for three days. In this diary, the average daily urinary frequency will be recorded.
measure: The number of nocturia measured with voiding diary
time frame: Change from baseline the average number of nocturia at 6 weeks
description: Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of nocturia will be recorded.
measure: The number of urinary incontinence measured with voiding diary
time frame: Change from baseline the average number of urinary incontinence at 6 weeks
description: Patients will be also instructed to keep voiding diary for three days. In this diary, the average number of urinary incontinence will be recorded.
measure: pelvic floor muscle strength measured with Modified Oxford Grading scale
time frame: Change from baseline pelvic floor muscle strength at 6 weeks
description: The modified Oxford Grading Scale quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.
measure: quality of life assessed with King's Health Questionnaire (KHQ)
time frame: Change from baseline quality of life at 6 weeks
description: King's Health Questionnaire assessing quality of life related to urinary problems will be used. This questionnaire consists of two parts and 32 items. The first part (21 items) contains two single-item questions that address General Health Perception and Incontinence Impact and the following seven multi-item domains: Role, Physical, and Social Limitations, Limitations in Personal Relationship, Emotional Problems, Sleep and Energy Disturbances associated with UI, and Severity Measures for UI. The second part has an 11-item Symptom Severity Scale (SSS) that assesses the presence and severity of urinary symptoms. While the entire SSS is scored from 0 (best) to 30 (worst), the minimum possible score is 0 (best health) and the maximum possible score is 100 (worst health) for all other KHQ domains.
arm group label: Kinesio tape group
arm group type: Experimental
description: Kinesio tape application and pelvic floor exercise have been applied
arm group label: Control group
arm group type: Sham Comparator
description: Sham kinesio tape application and pelvic floor exercise have been applied
intervention type: Other
intervention name: Kinesio tape application
description: Kinesio tape application combined with pelvic floor exercises will be performed.Taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
arm group label: Kinesio tape group
intervention type: Other
intervention name: Sham tape application
description: Sham tape application combined with pelvic floor exercises will be performed.Sham taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
arm group label: Control group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Seyda TOPRAK CELENAY
role: Principal Investigator
affiliation: Ankara Yildirim Beyazıt University
last name: Zehra Korkut
role: Study Chair
affiliation: KTO Karatay University
last name: Kemal Oskay
role: Study Chair
affiliation: Ankara Gazi Mustafa Kemal Hospital
last name: Seyda TOPRAK CELENAY
phone: +90-534-041-3986
email: sydtoprak@hotmail.com
last name: Zehra KORKUT
phone: +90-507-614-70-80
email: zehrakorkut85@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ataturk Training and Research Hospital
investigator full name: Seyda TOPRAK CELENAY
investigator title: Assistant Professor
mesh term: Urinary Bladder, Overactive