<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/NCT03250650</url>
  </required_header>
  <id_info>
    <org_study_id>63041516.7.0000.0068</org_study_id>
    <nct_id>NCT03250650</nct_id>
  </id_info>
  <brief_title>Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment</brief_title>
  <acronym>OAB</acronym>
  <official_title>Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and&#xD;
      transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female&#xD;
      overactive bladder syndrome (OAB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary&#xD;
      Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2&#xD;
      equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for&#xD;
      30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of&#xD;
      Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using&#xD;
      10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at&#xD;
      the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All&#xD;
      patients were evaluated before and after treatment by a voiding diary, King´s Health&#xD;
      questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire&#xD;
      (OABV-8).The analyzed variables included day and night time frequency, urgency and urge&#xD;
      incontinence.&#xD;
&#xD;
      The sample calculation was based on the difference waited between 2 groups regarding the&#xD;
      frequency improvment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2017</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>
    <intervention_model_description>Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All the questionnaires (OABV-8, King´s Health, Anamnesis), Function Avaliation of Pelvic Floor Muscles, before and after treatment will be conduced by other person who is not the responsable for the research.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Decreasing the numbers of urinary frequency during day and night</measure>
    <time_frame>1 month</time_frame>
    <description>We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of miccional urgency and urinary urgency incontinence</measure>
    <time_frame>2 months</time_frame>
    <description>We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Overactive Bladder Syndrome</condition>
  <arm_group>
    <arm_group_label>Group 1: TTNS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: ES + TTNS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TTNS</intervention_name>
    <description>Transcutaneous tibial electric stimulation</description>
    <arm_group_label>Group 1: TTNS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ES+TTNS</intervention_name>
    <description>Transvaginal electric stimulation</description>
    <arm_group_label>Group 2: ES + TTNS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with Overactive Bladder Syndrom no neurogenic or Mixed Incontinence&#xD;
             Urinary with overactive bladder´s predominance symptoms more than 6 months.&#xD;
&#xD;
          -  Over 18 years old.&#xD;
&#xD;
          -  Normal cognitive level to understand the orientations during the treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stress Urinary Incontinence&#xD;
&#xD;
          -  Drugs treatment for overactive bladder&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Neurologic diseases&#xD;
&#xD;
          -  Urinary infecction&#xD;
&#xD;
          -  Cystocele, rectocele and uterine prolapse&#xD;
&#xD;
          -  Infectious contagious diseases&#xD;
&#xD;
          -  Metal implants on the hip or lower members&#xD;
&#xD;
          -  Cardiac pacemaker&#xD;
&#xD;
          -  Bladder tumor&#xD;
&#xD;
          -  Vaginal infecction&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth A Ferreira, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernanda B Giarreta</last_name>
    <role>Study Chair</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade de São Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo General Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth Alves Gonçalves Ferreira</investigator_full_name>
    <investigator_title>Professor, PhD</investigator_title>
  </responsible_party>
  <keyword>Overactive Bladder</keyword>
  <keyword>Electric Stimulation</keyword>
  <keyword>Physical Therapy Modalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share participant data with other researchers.</ipd_description>
  </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/NCT03250650
org study id: 63041516.7.0000.0068
nct id: NCT03250650
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and
      transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female
      overactive bladder syndrome (OAB).
This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary
      Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2
      equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for
      30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of
      Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using
      10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at
      the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All
      patients were evaluated before and after treatment by a voiding diary, King´s Health
      questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire
      (OABV-8).The analyzed variables included day and night time frequency, urgency and urge
      incontinence.

      The sample calculation was based on the difference waited between 2 groups regarding the
      frequency improvment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All the questionnaires (OABV-8, King´s Health, Anamnesis), Function Avaliation of Pelvic Floor Muscles, before and after treatment will be conduced by other person who is not the responsable for the research.
measure: Decreasing the numbers of urinary frequency during day and night
time frame: 1 month
description: We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.
measure: Improvement of miccional urgency and urinary urgency incontinence
time frame: 2 months
description: We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.
arm group label: Group 1: TTNS
arm group type: Active Comparator
description: Intervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes.
arm group label: Group 2: ES + TTNS
arm group type: Experimental
description: Intervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1.
intervention type: Device
intervention name: TTNS
description: Transcutaneous tibial electric stimulation
arm group label: Group 1: TTNS
intervention type: Device
intervention name: ES+TTNS
description: Transvaginal electric stimulation
arm group label: Group 2: ES + TTNS
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth A Ferreira, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
last name: Fernanda B Giarreta
role: Study Chair
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo General Hospital
investigator full name: Elizabeth Alves Gonçalves Ferreira
investigator title: Professor, PhD
mesh term: Urinary Bladder, Overactive
mesh term: Syndrome
sharing ipd: No
ipd description: There is no plan to share participant data with other researchers.