<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/NCT03042351</url>
  </required_header>
  <id_info>
    <org_study_id>IP-ENNA-2015</org_study_id>
    <nct_id>NCT03042351</nct_id>
  </id_info>
  <brief_title>Pilot Study for the Urinary Incontinence Treatment</brief_title>
  <official_title>Pilot Study for the Urinary Incontinence Treatment by Using a Pelvic Floor Muscles Restorative Device (E-NNA®)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Palacios</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>eCareYou Innovation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Palacios</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non invasive study to improve the urinary incontinence, through pelvic floor muscles&#xD;
      exercises&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A non invasive study to improve the urinary incontinence performed in 36 women from two&#xD;
      groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor&#xD;
      muscles exercises with a restorative pelvic floor device every day for two months using the&#xD;
      Magic Kegel app download in their mobile devices&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in values registered in Magic Kegel App</measure>
    <time_frame>Six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in ICIQ-SF questionnaire at month 2 respect to baseline</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in FSFI questionnaire at month 2 respect to baseline</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Sandvick questionnaire at month 2 respect to baseline</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PISQ-12 questionnaire at month 2 respect to baseline</measure>
    <time_frame>60 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Unique arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Magic Kegel app</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magic Kegel app</intervention_name>
    <description>Pelvic floor muscles recover exercises with a specific device and Magic Kegel App</description>
    <arm_group_label>Unique arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urinary incontinence diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No urinary infection&#xD;
&#xD;
          -  No surgery for urinary incontinence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santiago Palacios, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Palacios</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Palacios</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 4, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary Incontinence</keyword>
  <keyword>Pelvic Floor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03042351
org study id: IP-ENNA-2015
nct id: NCT03042351
lead sponsor: 
collaborator: 
has dmc: No
Non invasive study to improve the urinary incontinence, through pelvic floor muscles
      exercises
A non invasive study to improve the urinary incontinence performed in 36 women from two
      groups: 18 menopausal women and 18 fertile women. The participants have to do pelvic floor
      muscles exercises with a restorative pelvic floor device every day for two months using the
      Magic Kegel app download in their mobile devices
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes in values registered in Magic Kegel App
time frame: Six months
measure: Changes in ICIQ-SF questionnaire at month 2 respect to baseline
time frame: 60 days
measure: Changes in FSFI questionnaire at month 2 respect to baseline
time frame: 60 days
measure: Changes in Sandvick questionnaire at month 2 respect to baseline
time frame: 60 days
measure: Changes in PISQ-12 questionnaire at month 2 respect to baseline
time frame: 60 days
arm group label: Unique arm
arm group type: Other
description: Magic Kegel app
intervention type: Device
intervention name: Magic Kegel app
description: Pelvic floor muscles recover exercises with a specific device and Magic Kegel App
arm group label: Unique arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Santiago Palacios, MD
role: Principal Investigator
affiliation: Instituto Palacios
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No