<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/NCT03784170</url>
  </required_header>
  <id_info>
    <org_study_id>CIP-002</org_study_id>
    <nct_id>NCT03784170</nct_id>
  </id_info>
  <brief_title>FemPulse Therapy for Overactive Bladder in Women</brief_title>
  <acronym>EVANESCE-OAB</acronym>
  <official_title>Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FemPulse Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FemPulse Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical trial is to investigate a new medical device treatment for&#xD;
      Overactive Bladder (OAB) in women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to&#xD;
      nerves that regulate bladder function. It is believed that stimulation of these nerves may&#xD;
      help relieve the symptoms of OAB.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All device- and procedure-related adverse events will be collected and tabulated</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>Adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary frequency</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>Frequency of and intervals between urinary voids (voids per day and time between voids)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urinary urgency</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>Presence or absence of urgency with each void</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urge urinary incontinence (UUI)</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>Presence or absence of UUI with each void</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OAB-q - Short Form</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>OAB bother quality of life questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OAB Symptom Score</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>OAB symptoms quality of life questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urogenital Distress Inventory - Short Form</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>OAB-related distress quality of life questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incontinence Impact Questionnaire - Short Form</measure>
    <time_frame>Approximately 11 days in total</time_frame>
    <description>Impact of OAB quality of life questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Urinary Bladder, Overactive</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FemPulse System at one device setting</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>FemPulse System at a different device setting</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FemPulse System</intervention_name>
    <description>Device therapy with the FemPulse System</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females 21 years or older with a diagnosis of Overactive Bladder&#xD;
&#xD;
          -  If of reproductive age, must use a reliable form of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, was recently pregnant or is trying to conceive&#xD;
&#xD;
          -  Has a metal pelvic implant or any electrically active implanted medical device&#xD;
&#xD;
          -  Had a previous hysterectomy, pelvic radiation or pelvic cancer&#xD;
&#xD;
          -  Has significant pelvic organ prolapse&#xD;
&#xD;
          -  Had bladder treatment with onabotulinumtoxinA in the previous 12 months&#xD;
&#xD;
          -  Has a significant heart condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minnesota Urology</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McKay Urology</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>November 6, 2019</last_update_submitted>
  <last_update_submitted_qc>November 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Overactive Bladder</keyword>
  <keyword>OAB</keyword>
  <keyword>Women</keyword>
  <keyword>Neuromodulation</keyword>
  <keyword>Bioelectronic Medicine</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>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/NCT03784170
org study id: CIP-002
nct id: NCT03784170
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this clinical trial is to investigate a new medical device treatment for
      Overactive Bladder (OAB) in women.
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to
      nerves that regulate bladder function. It is believed that stimulation of these nerves may
      help relieve the symptoms of OAB.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will wear a device and will be treated at 1 of 2 device settings for approximately 3 days.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: All device- and procedure-related adverse events will be collected and tabulated
time frame: Approximately 11 days in total
description: Adverse events
measure: Urinary frequency
time frame: Approximately 11 days in total
description: Frequency of and intervals between urinary voids (voids per day and time between voids)
measure: Urinary urgency
time frame: Approximately 11 days in total
description: Presence or absence of urgency with each void
measure: Urge urinary incontinence (UUI)
time frame: Approximately 11 days in total
description: Presence or absence of UUI with each void
measure: OAB-q - Short Form
time frame: Approximately 11 days in total
description: OAB bother quality of life questionnaire
measure: OAB Symptom Score
time frame: Approximately 11 days in total
description: OAB symptoms quality of life questionnaire
measure: Urogenital Distress Inventory - Short Form
time frame: Approximately 11 days in total
description: OAB-related distress quality of life questionnaire
measure: Incontinence Impact Questionnaire - Short Form
time frame: Approximately 11 days in total
description: Impact of OAB quality of life questionnaire
arm group label: Treatment
arm group type: Experimental
description: FemPulse System at one device setting
arm group label: Control
arm group type: Sham Comparator
description: FemPulse System at a different device setting
intervention type: Device
intervention name: FemPulse System
description: Device therapy with the FemPulse System
arm group label: Control
arm group label: Treatment
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
sharing ipd: No