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/NCT05977634</url>
    </required_header>
    <id_info>
      <org_study_id>Ege 19-12.3/5</org_study_id>
      <nct_id>NCT05977634</nct_id>
    </id_info>
    <brief_title>Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder</brief_title>
    <official_title>The Efficacy of Transcutaneous Tibial Nerve Stimulation on Symptoms of Overactive Bladder and Quality of Life in Women With Idiopathic Overactive Bladder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ege 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>
        This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on&#xD;
        symptoms of overactive bladder in women with idiopathic overactive bladder&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Idiopathic overactive bladder is defined the presence of a sense of urgency with or without&#xD;
        accompanying urinary incontinence without an organic pathology or urinary infection. Its&#xD;
        prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized&#xD;
        controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation&#xD;
        on symptoms of overactive bladder in women with idiopathic overactive bladder.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">August 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 30, 2026</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 (Investigator, Outcomes Assessor)</masking>
      <masking_description>Outcome assessor and investigator that assesses the patients will be blind to the study groups</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Urination frequency</measure>
      <time_frame>1 day</time_frame>
      <description>The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire</measure>
      <time_frame>1 day</time_frame>
      <description>This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of life. King's quality of life questionnaire</measure>
      <time_frame>1 day</time_frame>
      <description>This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Level of satisfaction with the treatment. Visual analog scale</measure>
      <time_frame>1 day</time_frame>
      <description>After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incontinence impact questionnaire-7.</measure>
      <time_frame>1 day</time_frame>
      <description>This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Overactive Bladder</condition>
    <condition>Overactive Bladder Syndrome</condition>
    <condition>Overactive Detrusor</condition>
    <arm_group>
      <arm_group_label>Transcutaneous tibial nerve stimulation plus bladder training</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Bladder training</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Bladder training</intervention_name>
      <description>Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom</description>
      <arm_group_label>Bladder training</arm_group_label>
      <arm_group_label>Transcutaneous tibial nerve stimulation plus bladder training</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous tibial nerve stimulation</intervention_name>
      <description>A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.</description>
      <arm_group_label>Transcutaneous tibial nerve stimulation plus bladder training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Overactive Bladder Questionnaire Validation Study questionnaire 8 scores higher than&#xD;
               11.&#xD;
  &#xD;
            -  Post voiding residue levels less than 100 ml.&#xD;
  &#xD;
            -  Women aged between 18-70&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of pelvic surgery&#xD;
  &#xD;
            -  Pelvic organ prolapsus of grade 2 or more.&#xD;
  &#xD;
            -  Current urinary tract infection&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only biological females will be enrolled in the study.</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ece Cinar, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ege University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ece Cinar, MD</last_name>
      <phone>00905372257018</phone>
      <email>ece.cinar@ege.edu.tr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yesim Akkoc, MD</last_name>
      <phone>00902323903690</phone>
      <email>yesim.akkoc@ege.edu.tr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ege University School of Medicine</name>
        <address>
          <city>Bornova</city>
          <state>Izmir</state>
          <zip>35100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>Ece Cinar, MD</last_name>
        <phone>005372257018</phone>
        <email>ece.cinar@ege.edu.tr</email>
      </contact>
      <contact_backup>
        <last_name>Yesim Akkoc, MD</last_name>
        <phone>00902323903690</phone>
        <email>yesim.akkoc@ege.edu.tr</email>
      </contact_backup>
      <investigator>
        <last_name>Yesim Akkoc, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ece Cinar, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Esra Cansu Selbes, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ahmet Ozgur Yeniel, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gokay Celtik, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.</citation>
      <PMID>27921161</PMID>
    </reference>
    <reference>
      <citation>Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.</citation>
      <PMID>30311692</PMID>
    </reference>
    <reference>
      <citation>Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.</citation>
      <PMID>25623739</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ege University</investigator_affiliation>
      <investigator_full_name>Ece Cinar</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>tibial nerve stimulation</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>Yes</sharing_ipd>
      <ipd_description>May be shared when requested</ipd_description>
    </patient_data>
    <!-- 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/NCT05977634
  org study id: Ege 19-12.3/5
  nct id: NCT05977634
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study was designed to assess the efficacy of trans cutaneous tibial nerve stimulation on
        symptoms of overactive bladder in women with idiopathic overactive bladder
  Idiopathic overactive bladder is defined the presence of a sense of urgency with or without
        accompanying urinary incontinence without an organic pathology or urinary infection. Its
        prevalence was reported to be between 7.7 to 31 % in women. In this prospective randomized
        controlled study, we aim to assess the efficacy of trans cutaneous tibial nerve stimulation
        on symptoms of overactive bladder in women with idiopathic overactive bladder.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Outcome assessor and investigator that assesses the patients will be blind to the study groups
  measure: Urination frequency
  time frame: 1 day
  description: The frequency of urination will be recorded by using a bladder diary. Urination frequency will be questioned before and after the study period.
  measure: Severity of overactive bladder symptoms. Overactive Bladder Questionnaire Validation Study questionnaire
  time frame: 1 day
  description: This questionnaire assesses the severity of overactive bladder symptoms in 8 items. Each item is scored from 0 to 5. Higher scores denote worse symptom severity. Maximum score is 40. A score over 11 denotes presence of overactive bladder symptoms. Questionnaire will be answered before and after the treatment period.
  measure: Quality of life. King's quality of life questionnaire
  time frame: 1 day
  description: This questionnaire includes a total of 19 questions assessing general quality of life and also questions related to urinary symptoms. Maximum score is 100 and higher scores denote lower levels of quality of life. Questionnaire will be answered before and after the treatment period.
  measure: Level of satisfaction with the treatment. Visual analog scale
  time frame: 1 day
  description: After the completion of the study period, patients will be asked to assess their levels of satisfaction with the treatment they received on a visual analog scale.
  measure: Incontinence impact questionnaire-7.
  time frame: 1 day
  description: This 7 item questionnaire assesses the impact of urinary incontinence on the patients' daily lives. Maximum score is 100. Higher scores denote worse outcomes. Questionnaire will be answered before and after the treatment period.
  arm group label: Transcutaneous tibial nerve stimulation plus bladder training
  arm group type: Experimental
  description: Patients will receive transcutaneous tibial nerve stimulation for 30 minutes, twice a week, for 6 weeks. Application will be done in an outpatient setting, using disposable surface electrodes.
  arm group label: Bladder training
  arm group type: Other
  description: patients will receive only the routine education program that is given to every patient with idiopathic overactive bladder syndrome. This includes education about the anatomy of the urinary system, patient motivation, and frequent bathroom visits in order to avoid incontinence with gradual increase between each visit to the bathroom.
  intervention type: Behavioral
  intervention name: Bladder training
  description: Bladder training has 4 components, educating the patient about anatomy, fluid intake control, pelvic floor muscle contractions and increasing the interval between visits to the bathroom
  arm group label: Bladder training
  arm group label: Transcutaneous tibial nerve stimulation plus bladder training
  intervention type: Device
  intervention name: Transcutaneous tibial nerve stimulation
  description: A combined electrotherapy device capable of applying transcutaneous electrical nerve stimulation will be used. Each session will take 30 minutes. Patient will visit the hospital twice a week for 6 weeks. An electrical current of 0-50 amperes with a frequency of 20 herz, and a duration of 200 micro seconds will be applied using 50x50 mm surface electordes. The aim is to create a tingling sensation without causing any pain on the tibial nerve, at the ankle level.
  arm group label: Transcutaneous tibial nerve stimulation plus bladder training
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only biological females will be enrolled in the study.
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Ece Cinar, MD
  role: Principal Investigator
  affiliation: Ege University School of Medicine
  last name: Ece Cinar, MD
  phone: 00905372257018
  email: ece.cinar@ege.edu.tr
  last name: Yesim Akkoc, MD
  phone: 00902323903690
  email: yesim.akkoc@ege.edu.tr
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Turkey
  citation: Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
  PMID: 27921161
  citation: Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
  PMID: 30311692
  citation: Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.
  PMID: 25623739
  responsible party type: Principal Investigator
  investigator affiliation: Ege University
  investigator full name: Ece Cinar
  investigator title: Assistant Professor
  mesh term: Urinary Bladder, Overactive
  sharing ipd: Yes
  ipd description: May be shared when requested