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/NCT06024005</url>
    </required_header>
    <id_info>
      <org_study_id>TTNS for OAB</org_study_id>
      <nct_id>NCT06024005</nct_id>
    </id_info>
    <brief_title>Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder</brief_title>
    <official_title>A Prospective Randomized Controlled Trial: Comparison of the Transcutaneous Posterior Tibial Nerve Stimulation and Oral Solifenacin Treatments' Effects in Women Between 18-80 Years Old Who Have 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>
        Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency,&#xD;
        frequent urination, nocturia, and urge incontinence without any identifiable organic cause,&#xD;
        significantly impacting the quality of life. One of the most prominent symptoms is the&#xD;
        urgency to urinate accompanied by a sudden sensation of bladder fullness.&#xD;
  &#xD;
        There are various treatment options available for managing OAB, including conservative&#xD;
        therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin&#xD;
        as the standard medical treatment for OAB, offering advantages such as not being affected by&#xD;
        food intake, efficacy regardless of gender, and high bioavailability. However, it is known to&#xD;
        cause discontinuation of treatment in many cases due to the occurrence of side effects.&#xD;
        Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been&#xD;
        internationally recognized and proven effective in the treatment of OAB, providing several&#xD;
        advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous&#xD;
        (TTNS). PTNS is an invasive method that requires specialized equipment and a trained&#xD;
        healthcare professional, which limits its routine use due to treatment costs.&#xD;
  &#xD;
        In the literature, it is stated that in the treatment of OAB, alone or combined PTNS&#xD;
        applications are superior to drug monotherapies, but there are limited studies on this&#xD;
        subject. Therefore, the study aim was to compare the efficacy, side effects and quality of&#xD;
        life of solifenacin and TTNS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the inclusion and exclusion criteria, 34 female patients with OAB were enrolled&#xD;
        in the study. The patients were randomly divided into two groups, with 17 individuals in each&#xD;
        group. Patients with odd case numbers were assigned to the Oral Solifenacin group, while&#xD;
        those with even case numbers were assigned to the TTNS group.&#xD;
  &#xD;
        Prior to treatment, the sociodemographic characteristics, birth history, and past treatment&#xD;
        information of all participants were recorded. Basic urogynecological evaluation, pelvic&#xD;
        floor ultrasound, and urine culture were performed. To assess symptoms and quality of life,&#xD;
        the Overactive Bladder Assessment Form (OAB-V8), Incontinence Quality of Life Scale (I-QQL),&#xD;
        Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a&#xD;
        three-day bladder diary were used. After 6 weeks of treatment, all evaluations were repeated.&#xD;
        The treatment regimen consisted of once-daily oral solifenacin for the medication group and 2&#xD;
        sessions per week, 30 minutes per session, for 12 sessions using the Urostim-2 device for the&#xD;
        TTNS group. The stimulation intensity was increased until a motor or sensory response was&#xD;
        obtained, and the threshold value was determined. The entire TTNS procedure was performed&#xD;
        under the supervision of an expert physician at the Urogynecology Outpatient Clinic of Ege&#xD;
        University Hospital. Statistical analysis was conducted using SPSS 20.0.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 18, 2023</start_date>
    <completion_date type="Actual">May 24, 2023</completion_date>
    <primary_completion_date type="Actual">May 24, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Total Daily Incontinence Episodes</measure>
      <time_frame>6 weeks</time_frame>
      <description>It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Evaluation of Quality of Life</measure>
      <time_frame>6 weeks</time_frame>
      <description>The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Symptom Assessment</measure>
      <time_frame>6 weeks</time_frame>
      <description>Overactive Bladder Assessment Form (OAB-V8), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A higher score means a worse outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom Assessment</measure>
      <time_frame>6 weeks</time_frame>
      <description>Urogenital Distress Inventory (UDI-6), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symptom Assessment</measure>
      <time_frame>6 weeks</time_frame>
      <description>Incontinence Impact Questionnaire (IIQ-7), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">34</enrollment>
    <condition>Overactive Bladder</condition>
    <condition>Overactive Bladder Syndrome</condition>
    <arm_group>
      <arm_group_label>Device Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Transcutaneous device group with Urostim 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Drug Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Drug Group with Kinzy 5 mg</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral Solifenacin 5mg</intervention_name>
      <description>Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks</description>
      <arm_group_label>Drug Group</arm_group_label>
      <other_name>Kinzy 5mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)</intervention_name>
      <description>Application of TTNS twice a week for 6 weeks, with each session for 30 minutes</description>
      <arm_group_label>Device Group</arm_group_label>
      <other_name>Urostim 2</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients with a diagnosis of OAB and unresponsive to first-line treatment,&#xD;
  &#xD;
            -  Absence of genito-urinary system malformations that may cause pollacullaire,&#xD;
  &#xD;
            -  Volunteering to participate in the research,&#xD;
  &#xD;
            -  To be literate in Turkish&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a urinary tract infection,&#xD;
  &#xD;
            -  Having pelvic organ prolapse greater than stage 2,&#xD;
  &#xD;
            -  To be diagnosed with stress type urinary incontinence,&#xD;
  &#xD;
            -  Having narrow-angle glaucoma, myasthenia gravis and severe gastro-intestinal diseases,&#xD;
  &#xD;
            -  Patients undergoing hemodialysis,&#xD;
  &#xD;
            -  Having severe liver or kidney failure,&#xD;
  &#xD;
            -  Pregnancy,&#xD;
  &#xD;
            -  Having a pacemaker&#xD;
  &#xD;
            -  Presence of epilepsy,&#xD;
  &#xD;
            -  The presence of built-in metal in the ankle&#xD;
  &#xD;
            -  Open ankle wound&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmet Ozgur OY Yeniel</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ege University School of Medicine, Department of Obstetrics and Gynecology,</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ege University, School of Medicine, Department of Obstetrics and Gynecology</name>
        <address>
          <city>İzmir</city>
          <zip>35100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ege University</investigator_affiliation>
      <investigator_full_name>Ahmet Ozgur Yeniel</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Overactive Bladder</keyword>
    <keyword>Transcutaneous Electric Nerve Stimulation</keyword>
    <keyword>Neuromodulation</keyword>
    <keyword>Urge Urinary Incontinence</keyword>
    <keyword>Quality of Life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Bladder, Overactive</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Solifenacin Succinate</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06024005
  org study id: TTNS for OAB
  nct id: NCT06024005
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency,
        frequent urination, nocturia, and urge incontinence without any identifiable organic cause,
        significantly impacting the quality of life. One of the most prominent symptoms is the
        urgency to urinate accompanied by a sudden sensation of bladder fullness.
  
        There are various treatment options available for managing OAB, including conservative
        therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin
        as the standard medical treatment for OAB, offering advantages such as not being affected by
        food intake, efficacy regardless of gender, and high bioavailability. However, it is known to
        cause discontinuation of treatment in many cases due to the occurrence of side effects.
        Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been
        internationally recognized and proven effective in the treatment of OAB, providing several
        advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous
        (TTNS). PTNS is an invasive method that requires specialized equipment and a trained
        healthcare professional, which limits its routine use due to treatment costs.
  
        In the literature, it is stated that in the treatment of OAB, alone or combined PTNS
        applications are superior to drug monotherapies, but there are limited studies on this
        subject. Therefore, the study aim was to compare the efficacy, side effects and quality of
        life of solifenacin and TTNS.
  According to the inclusion and exclusion criteria, 34 female patients with OAB were enrolled
        in the study. The patients were randomly divided into two groups, with 17 individuals in each
        group. Patients with odd case numbers were assigned to the Oral Solifenacin group, while
        those with even case numbers were assigned to the TTNS group.
  
        Prior to treatment, the sociodemographic characteristics, birth history, and past treatment
        information of all participants were recorded. Basic urogynecological evaluation, pelvic
        floor ultrasound, and urine culture were performed. To assess symptoms and quality of life,
        the Overactive Bladder Assessment Form (OAB-V8), Incontinence Quality of Life Scale (I-QQL),
        Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6), and a
        three-day bladder diary were used. After 6 weeks of treatment, all evaluations were repeated.
        The treatment regimen consisted of once-daily oral solifenacin for the medication group and 2
        sessions per week, 30 minutes per session, for 12 sessions using the Urostim-2 device for the
        TTNS group. The stimulation intensity was increased until a motor or sensory response was
        obtained, and the threshold value was determined. The entire TTNS procedure was performed
        under the supervision of an expert physician at the Urogynecology Outpatient Clinic of Ege
        University Hospital. Statistical analysis was conducted using SPSS 20.0.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Total Daily Incontinence Episodes
  time frame: 6 weeks
  description: It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.
  measure: Evaluation of Quality of Life
  time frame: 6 weeks
  description: The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
  measure: Symptom Assessment
  time frame: 6 weeks
  description: Overactive Bladder Assessment Form (OAB-V8), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A higher score means a worse outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
  measure: Symptom Assessment
  time frame: 6 weeks
  description: Urogenital Distress Inventory (UDI-6), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
  measure: Symptom Assessment
  time frame: 6 weeks
  description: Incontinence Impact Questionnaire (IIQ-7), was used for symptomatic evaluation and to assess the impact of symptoms on quality of life. It is a validated questionnaire. A lesser score means a better outcome. Meaningful for patients. It is standardized. The patient's daily activities are taken into account. Subjective. Subject to variability. Not correlated with the severity of urine leakage.
  arm group label: Device Group
  arm group type: Active Comparator
  description: Transcutaneous device group with Urostim 2
  arm group label: Drug Group
  arm group type: Active Comparator
  description: Drug Group with Kinzy 5 mg
  intervention type: Drug
  intervention name: Oral Solifenacin 5mg
  description: Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks
  arm group label: Drug Group
  other name: Kinzy 5mg
  intervention type: Device
  intervention name: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
  description: Application of TTNS twice a week for 6 weeks, with each session for 30 minutes
  arm group label: Device Group
  other name: Urostim 2
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Ahmet Ozgur OY Yeniel
  role: Principal Investigator
  affiliation: Ege University School of Medicine, Department of Obstetrics and Gynecology,
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ege University
  investigator full name: Ahmet Ozgur Yeniel
  investigator title: Professor
  mesh term: Urinary Bladder, Overactive
  mesh term: Solifenacin Succinate