<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/NCT02220946</url>
  </required_header>
  <id_info>
    <org_study_id>EVESFDS</org_study_id>
    <nct_id>NCT02220946</nct_id>
  </id_info>
  <brief_title>Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction</brief_title>
  <acronym>EVESOFS</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      vaginal electrical stimulation improves female sexual dysfunction&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</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 (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Female Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>Vaginal Electrical Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. Each patient received a 20 minute session once a week for total 8 sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>plasebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>sham electrical stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal Electrical Stimulation</intervention_name>
    <description>A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off. the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. each patient received a 20 minute session once a week for total 8 session</description>
    <arm_group_label>Vaginal Electrical Stimulation</arm_group_label>
    <other_name>MyoBravo Electrical Stimulation Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with complaint of sexual dysfunction at any part of sexual cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1&#xD;
             women with neurological disease and anatomical defect women with anatomical defect&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Obstetric and Gynecology, Bezmialem Vakif University</name>
      <address>
        <city>İstanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 17, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>August 19, 2014</last_update_submitted>
  <last_update_submitted_qc>August 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>serdar aydin</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Vaginal Electrical Stimulation</keyword>
  <!-- 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/NCT02220946
org study id: EVESFDS
nct id: NCT02220946
lead sponsor: 
collaborator: 
has dmc: No
vaginal electrical stimulation improves female sexual dysfunction
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
time frame: Baseline, Week 8
measure: Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8
time frame: Baseline, Week 8
arm group label: Vaginal Electrical Stimulation
arm group type: Active Comparator
description: A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. Each patient received a 20 minute session once a week for total 8 sessions
arm group label: plasebo
arm group type: Placebo Comparator
description: sham electrical stimulation
intervention type: Device
intervention name: Vaginal Electrical Stimulation
description: A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off. the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. each patient received a 20 minute session once a week for total 8 session
arm group label: Vaginal Electrical Stimulation
other name: MyoBravo Electrical Stimulation Device
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: serdar aydin
investigator title: MD