<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/NCT03029624</url>
  </required_header>
  <id_info>
    <org_study_id>111-3175</org_study_id>
    <nct_id>NCT03029624</nct_id>
  </id_info>
  <brief_title>eCoin Tibial Nerve Stimulation for OAB</brief_title>
  <official_title>Subcutaneous Tibial Nerve Stimulation for Urgency Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valencia Technologies Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Valencia Technologies Corporation</source>
  <oversight_info>
    <has_dmc>Yes</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a single arm, prospective study of the safety and effectiveness of the Valencia&#xD;
      Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with&#xD;
      refractory urgency urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial&#xD;
      nerve stimulation in 25 subjects with refractory overactive bladder as defined by the&#xD;
      American Urological Association.. The eCoin neuromodulation device will be implanted&#xD;
      subcutaneously in the right or left leg of patients with urgency urinary incontinence. After&#xD;
      a 4 week implant healing period, subjects will have their devices activated (turned ON).&#xD;
      After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will&#xD;
      be assessed. It is anticipated that subjects will reach the full therapeutic effect at&#xD;
      approximately 3 months of therapy. Subjects will be followed for an additional 9 months to&#xD;
      assess the safety of maintenance stimulation therapy with fewer sessions occurring during&#xD;
      this time interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</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>Incontinent Episodes</measure>
    <time_frame>Baseline to three months post-activation.</time_frame>
    <description>The change in number of incontinence episodes from baseline to three months post-activation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>System and Procedure Related AEs</measure>
    <time_frame>Implantation to one month post-implantation.</time_frame>
    <description>Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MAEs</measure>
    <time_frame>Baseline to 3 months post-activation.</time_frame>
    <description>Number of all Major Adverse Events from baseline to 3 months post-activation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Responders</measure>
    <time_frame>3 months after activation</time_frame>
    <description>Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Urgency Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Treatment Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment Arm receives implanted eCoin device and therapy is turned ON.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>eCoin</intervention_name>
    <description>Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
    <arm_group_label>Treatment Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women and men 18 years and older.&#xD;
&#xD;
          2. Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and&#xD;
             stress incontinence with a predominant urgency component, for at least 6 months&#xD;
             (self-reported).&#xD;
&#xD;
          3. Individual has at least four urgency incontinence episodes on a three-day voiding&#xD;
             diary with at least one episode per 24 hour time period&#xD;
&#xD;
          4. Individual with urinary frequency, defined as an average of greater than or equal to 8&#xD;
             times/24 hours (ie. a total of greater than or equal to 24 micturitions on a 3 day&#xD;
             diary)&#xD;
&#xD;
          5. Individual is unresponsive to, inadequately responsive to, or intolerant of&#xD;
             behavioral, rehabilitation, and pharmacologic therapy.&#xD;
&#xD;
          6. Individual is able to give his or her written, informed consent.&#xD;
&#xD;
          7. Individual is mentally competent and able to understand all study requirements.&#xD;
&#xD;
          8. Individual is willing and able to complete a 3-day voiding diary and quality of life&#xD;
             questionnaire.&#xD;
&#xD;
          9. Individual is without pharmacological treatment of overactive bladder (antimuscarinics&#xD;
             and beta-3 agonists) for 2 weeks prior to screening.&#xD;
&#xD;
         10. The individual demonstrates a positive nerve integrity test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individual has predominantly stress urinary incontinence&#xD;
&#xD;
          2. Individual has clinically significant bladder outlet obstruction.&#xD;
&#xD;
          3. Individual has clinically significant pelvic organ prolapse.&#xD;
&#xD;
          4. Individual has abnormal post void residual (i.e., greater than 150 cc).&#xD;
&#xD;
          5. Individual has clinically significant urethral stricture disease or bladder neck&#xD;
             contracture&#xD;
&#xD;
          6. Individual has an active urinary tract infection at time of enrollment.&#xD;
&#xD;
          7. Individual has recurrent urinary tract infections defined as 4 or more UTI's per year.&#xD;
&#xD;
          8. Individual has morbid obesity.&#xD;
&#xD;
          9. Individual has had positive urine cytology or diagnosis of bladder or prostate cancer.&#xD;
&#xD;
         10. Individual has neurogenic bladder dysfunction.&#xD;
&#xD;
         11. Individual is taking an alpha-blocker for benign prostatic hyperplasia.&#xD;
&#xD;
         12. Individual is pregnant or intends to become pregnant during the study.&#xD;
&#xD;
         13. Patient is breast feeding or is less than 9-month post-partum.&#xD;
&#xD;
         14. Individual has the presence of urinary fistula, bladder stone, or interstitial&#xD;
             cystitis.&#xD;
&#xD;
         15. Individual has uncontrolled diabetes mellitus.&#xD;
&#xD;
         16. Individual has a cardiac pacemaker or implanted defibrillator.&#xD;
&#xD;
         17. Individual has been previously treated with sacral nerve stimulation.&#xD;
&#xD;
         18. Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to&#xD;
             enrollment.&#xD;
&#xD;
         19. Individual has been treated with percutaneous tibial nerve stimulation within the&#xD;
             previous 12 weeks prior to enrollment.&#xD;
&#xD;
         20. Individual requires regular Magnetic Resonance Imaging for other health care&#xD;
             conditions. (ASK)&#xD;
&#xD;
         21. Individual has a clotting or bleeding disorder; antiplatelet and anticoagulant therapy&#xD;
             may be continued or held at the discretion of the investigator&#xD;
&#xD;
         22. Individual has a clinically significant peripheral neuropathy.&#xD;
&#xD;
         23. Individual is neutropenic or immunocompromised.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon English, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Urology Associates</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott MacDiarmid, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alliance Urology Specialists</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Clark Center for Urogynecology</name>
      <address>
        <city>Newport Beach</city>
        <state>California</state>
        <zip>92663</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UnityPoint Clinic</name>
      <address>
        <city>Waterloo</city>
        <state>Iowa</state>
        <zip>50703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Urology Specialists</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Institute for Female Pelvic Medicine &amp; Reconstructive Surgery (FPM Institute)</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Associates</name>
      <address>
        <city>Christchurch</city>
        <zip>8013</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roundhay Medical Centre</name>
      <address>
        <city>Nelson</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tauranga Urology Research Ltd</name>
      <address>
        <city>Tauranga</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>October 5, 2020</results_first_submitted>
  <results_first_submitted_qc>November 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 27, 2020</results_first_posted>
  <last_update_submitted>November 30, 2020</last_update_submitted>
  <last_update_submitted_qc>November 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03029624/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited and enrolled from April 2017 to September 2017 (i.e. 5 months). The study took place at 7 urology/urogynecology clinics across the United States and New Zealand.</recruitment_details>
      <pre_assignment_details>Participants were required to complete a 2-week washout of all overactive bladder medications prior to baseline. After passing screening and baseline criteria, patients were enrolled. As this is a single-arm study, once participants were enrolled they were assigned to the intervention (eCoin).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>eCoin</title>
          <description>Treatment arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Primary Endpoint (3 Months)</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>MRI need</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analyses includes the baseline information for enrolled and implanted participants. Data on 3 participants were imputed per protocol.</population>
      <group_list>
        <group group_id="B1">
          <title>eCoin</title>
          <description>Treatment Arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="46"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.39" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urinary incontinence</title>
          <units>episodes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.9" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urgency urinary incontinence</title>
          <units>episodes/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No. OAB medication at screening</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>No. OAB medication history</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Incontinence Quality of Life (I QoL) score</title>
          <description>Total score reported. Range from 0-100. Lower score indicates poor quality of life, higher score indicates better quality of life.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.39" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incontinent Episodes</title>
        <description>The change in number of incontinence episodes from baseline to three months post-activation.</description>
        <time_frame>Baseline to three months post-activation.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>eCoin</title>
            <description>Treatment Arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Incontinent Episodes</title>
          <description>The change in number of incontinence episodes from baseline to three months post-activation.</description>
          <population>Intent-to-treat</population>
          <units>episodes/day</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>System and Procedure Related AEs</title>
        <description>Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.</description>
        <time_frame>Implantation to one month post-implantation.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>eCoin</title>
            <description>Treatment Arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>System and Procedure Related AEs</title>
          <description>Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.</description>
          <population>Intent-to-treat</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MAEs</title>
        <description>Number of all Major Adverse Events from baseline to 3 months post-activation.</description>
        <time_frame>Baseline to 3 months post-activation.</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Arm</title>
            <description>Treatment Arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>MAEs</title>
          <description>Number of all Major Adverse Events from baseline to 3 months post-activation.</description>
          <population>Intent-to-treat</population>
          <units>Adverse Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Responders</title>
        <description>Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment</description>
        <time_frame>3 months after activation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eCoin</title>
            <description>Treatment arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Responders</title>
          <description>Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected from enrollment through 6 months after implantation.</time_frame>
      <desc>The safety population consisted of all eligible and enrolled participants. AEs were graded at the study centers as mild, moderate, or sever; serious or not serious; classified as related or unrelated; and classified as causing or not causing study termination. The Data Safety and Monitoring Board reviewed all AEs to confirm relatedness.</desc>
      <group_list>
        <group group_id="E1">
          <title>eCoin</title>
          <description>Treatment arm receives implanted eCoin device and therapy is turned ON.&#xD;
eCoin: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis Secondary to Ankle Wrap</sub_title>
                <description>One participant experienced cellulitis secondary to an ankle wrap that was part of the specified wound care but with no involvement of the incision or implant site. Cellulitis resolved with intravenous antibiotics.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <description>Participant contracted pneumonia determined to be unrelated to the device and resolved with treatment</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hip Bursitis &amp; Edema</sub_title>
                <description>Participant presented with limp and pain determined to be related to hip bursitis and edema, which were noted at screening.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mild swelling, bruising, discomfort</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Moderate implant site discomfort, swelling, pain, bruising</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Possible incision site infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Stimulation pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
              <event>
                <sub_title>Device migration about 1 cm posterior</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister secondary to ankle wrap</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This was a small study with a nonrandomized design and no control group. Studies in larger populations may clarify the factors associated with responders. The initial study period was short at only 3 months, and should be investigated further for durability.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Stacy Chambliss, Chief of Clinical Trials</name_or_title>
      <organization>Valencia Technologies</organization>
      <phone>661-775-1414 ext 1002</phone>
      <email>schambliss@valenciatechnologies.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03029624
org study id: 111-3175
nct id: NCT03029624
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The study is a single arm, prospective study of the safety and effectiveness of the Valencia
      Technologies eCoin System to stimulate the tibial nerve for the treatment of patients with
      refractory urgency urinary incontinence.
This trial is a single arm, prospective study of the safety and effectiveness of eCoin tibial
      nerve stimulation in 25 subjects with refractory overactive bladder as defined by the
      American Urological Association.. The eCoin neuromodulation device will be implanted
      subcutaneously in the right or left leg of patients with urgency urinary incontinence. After
      a 4 week implant healing period, subjects will have their devices activated (turned ON).
      After 3 months of device therapy (occurring 4 months post-implant), the primary endpoint will
      be assessed. It is anticipated that subjects will reach the full therapeutic effect at
      approximately 3 months of therapy. Subjects will be followed for an additional 9 months to
      assess the safety of maintenance stimulation therapy with fewer sessions occurring during
      this time interval.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incontinent Episodes
time frame: Baseline to three months post-activation.
description: The change in number of incontinence episodes from baseline to three months post-activation.
measure: System and Procedure Related AEs
time frame: Implantation to one month post-implantation.
description: Number of System and Procedure Related Adverse Events from implantation to one month post-implantation.
measure: MAEs
time frame: Baseline to 3 months post-activation.
description: Number of all Major Adverse Events from baseline to 3 months post-activation.
measure: Percentage of Responders
time frame: 3 months after activation
description: Percentage of Responders, defined as participants who experienced a 50% or greater reduction in UUI after 3 months of treatment
arm group label: Treatment Arm
arm group type: Experimental
description: Treatment Arm receives implanted eCoin device and therapy is turned ON.
intervention type: Device
intervention name: eCoin
description: Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.
arm group label: Treatment Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sharon English, MD
role: Principal Investigator
affiliation: Urology Associates
last name: Scott MacDiarmid, MD
role: Principal Investigator
affiliation: Alliance Urology Specialists
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This was a small study with a nonrandomized design and no control group. Studies in larger populations may clarify the factors associated with responders. The initial study period was short at only 3 months, and should be investigated further for durability.
point of contact: 