<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/NCT04506866</url>
  </required_header>
  <id_info>
    <org_study_id>MDT19006</org_study_id>
    <nct_id>NCT04506866</nct_id>
  </id_info>
  <brief_title>InterStim Micro Post Market Clinical Follow-up Study</brief_title>
  <acronym>ELITE</acronym>
  <official_title>Evaluation of InterStim Micro System Performance and Safety (ELITE) to Confirm Long-Term Outcomes - Post Market Clinical Follow-Up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedtronicNeuro</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedtronicNeuro</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Post-market clinical follow-up for continued assessment of safety and performance to confirm&#xD;
      long-term outcomes of the InterStim Micro System for sacral neuromodulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Actual">December 19, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overactive Bladder Cohort</measure>
    <time_frame>3 months</time_frame>
    <description>To demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fecal Incontinence Cohort</measure>
    <time_frame>3 months</time_frame>
    <description>To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-Obstructive Urinary Retention Cohort</measure>
    <time_frame>3 months</time_frame>
    <description>To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">148</enrollment>
  <condition>Overactive Bladder</condition>
  <condition>Fecal Incontinence</condition>
  <condition>Non-obstructive Urinary Retention</condition>
  <arm_group>
    <arm_group_label>Overactive Bladder Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fecal Incontinence Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Obstructive Urinary Retention Cohort</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>InterStim Micro</intervention_name>
    <description>Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use</description>
    <arm_group_label>Fecal Incontinence Cohort</arm_group_label>
    <arm_group_label>Non-Obstructive Urinary Retention Cohort</arm_group_label>
    <arm_group_label>Overactive Bladder Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Overactive Bladder Cohort&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of OAB as demonstrated on a 3-day voiding diary with greater than or&#xD;
             equal to 8 urgency frequency episodes per day and/or by having a minimum of 3 episodes&#xD;
             of urinary urge incontinence in 72 hours&#xD;
&#xD;
          2. Subjects 18 years of age or older&#xD;
&#xD;
          3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro&#xD;
             System labeling&#xD;
&#xD;
          4. Willing and able to accurately complete study diaries, questionnaires, attend visits,&#xD;
             device recharging and comply with the study protocol&#xD;
&#xD;
          5. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have neurological conditions such as multiple sclerosis, clinically significant&#xD;
             peripheral neuropathy or spinal cord injury (e.g., paraplegia)&#xD;
&#xD;
          2. Have primary stress incontinence or mixed incontinence where the stress component&#xD;
             overrides the urge component&#xD;
&#xD;
          3. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or&#xD;
             urethral stricture)&#xD;
&#xD;
          4. Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12&#xD;
             months&#xD;
&#xD;
          5. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic&#xD;
             diathermy&#xD;
&#xD;
          6. Women who are pregnant or planning to become pregnant&#xD;
&#xD;
          7. Characteristics indicating a poor understanding of the study or characteristics that&#xD;
             indicate the subject may have poor compliance with the study protocol requirements.&#xD;
&#xD;
          8. Concurrent participation in another clinical study that may add additional safety&#xD;
             risks and/or confound study results.&#xD;
&#xD;
        Fecal Incontinence Cohort&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of fecal incontinence as demonstrated by a 7-day bowel diary as&#xD;
             greater than or equal to 2 incontinent episodes of more than staining (i.e., either&#xD;
             slight, moderate or severe soiling)&#xD;
&#xD;
          2. Subjects 18 years of age or older&#xD;
&#xD;
          3. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro&#xD;
             System labeling&#xD;
&#xD;
          4. Willing and able to accurately complete study diaries, questionnaires, attend visits,&#xD;
             device recharging and comply with the study protocol&#xD;
&#xD;
          5. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have neurological conditions such as multiple sclerosis, clinically significant&#xD;
             peripheral neuropathy or spinal cord injury (e.g., paraplegia)&#xD;
&#xD;
          2. Uncorrected high grade internal rectal prolapse&#xD;
&#xD;
          3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic&#xD;
             diathermy&#xD;
&#xD;
          4. Women who are pregnant or planning to become pregnant&#xD;
&#xD;
          5. Characteristics indicating a poor understanding of the study or characteristics that&#xD;
             indicate the subject may have poor compliance with the study protocol requirements.&#xD;
&#xD;
          6. Concurrent participation in another clinical study that may add additional safety&#xD;
             risks and/or confound study results.&#xD;
&#xD;
        Non-Obstructive Urinary Retention Cohort&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of non-obstructive urinary retention as demonstrated by a 7-day&#xD;
             urinary voiding diary with a minimum of 5 clean intermittent self-catheterizations&#xD;
&#xD;
          2. Chronic non-obstructive urinary retention with an elevated post-void residual (PVR)&#xD;
             that has persisted for at least six months and is documented on two or more separate&#xD;
             occasions.&#xD;
&#xD;
          3. Subjects 18 years of age or older&#xD;
&#xD;
          4. Candidate for sacral neuromodulation therapy in accordance with the InterStim Micro&#xD;
             System labeling&#xD;
&#xD;
          5. Willing and able to accurately complete study diaries, questionnaires, attend visits,&#xD;
             device recharging and comply with the study protocol&#xD;
&#xD;
          6. Willing and able to provide signed and dated informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have neurological conditions such as multiple sclerosis, clinically significant&#xD;
             peripheral neuropathy or spinal cord injury (e.g., paraplegia)&#xD;
&#xD;
          2. Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or&#xD;
             urethral stricture)&#xD;
&#xD;
          3. Have knowledge of planned shortwave diathermy, microwave diathermy, or therapeutic&#xD;
             diathermy .&#xD;
&#xD;
          4. Women who are pregnant or planning to become pregnant&#xD;
&#xD;
          5. Characteristics indicating a poor understanding of the study or characteristics that&#xD;
             indicate the subject may have poor compliance with the study protocol requirements.&#xD;
&#xD;
          6. Concurrent participation in another clinical study that may add additional safety&#xD;
             risks and/or confound study results.&#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>Mylène Champs</last_name>
    <role>Study Director</role>
    <affiliation>Medtronic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>East Coast Institute for Research</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Urology Partners</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Urology</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017-3403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Urology (Woodbury)</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prisma Health</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colon Surgeons of Charleston</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Urology Partners of North Texas</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Urology Associates</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes - Hôtel Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire De Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum (MUMC)</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St.Gallen</name>
      <address>
        <city>Saint Gallen</city>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's &amp; St Thomas' NHS Foundation Trust - St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Netherlands</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Puerto Rico</country>
  </removed_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</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>Fecal Incontinence</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Retention</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/NCT04506866
org study id: MDT19006
nct id: NCT04506866
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Post-market clinical follow-up for continued assessment of safety and performance to confirm
      long-term outcomes of the InterStim Micro System for sacral neuromodulation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overactive Bladder Cohort
time frame: 3 months
description: To demonstrate an improvement in Overactive Bladder Quality of Life (OAB-q) Questionnaire Health Related Quality of Life (HRQL) total score at 3 months post-implant compared to baseline
measure: Fecal Incontinence Cohort
time frame: 3 months
description: To demonstrate an improvement in Cleveland Clinic Incontinence Score (CCIS) at 3 months post-implant compared to baseline
measure: Non-Obstructive Urinary Retention Cohort
time frame: 3 months
description: To demonstrate an improvement in number of clean intermittent self-catheterizations (CISC) per day at 3 months post-implant compared to baseline
arm group label: Overactive Bladder Cohort
arm group type: Other
description: Subjects with overactive bladder will be treated with InterStim Micro Therapy and followed-up regarding their overactive bladder symptoms.
arm group label: Fecal Incontinence Cohort
arm group type: Other
description: Subjects with fecal incontinence will be treated with InterStim Micro Therapy and followed-up regarding their fecal incontinence symptoms.
arm group label: Non-Obstructive Urinary Retention Cohort
arm group type: Other
description: Subjects with non-obstructive urinary retention will be treated with InterStim Micro Therapy and followed-up regarding their non-obstructive urinary retention symptoms.
intervention type: Device
intervention name: InterStim Micro
description: Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
arm group label: Fecal Incontinence Cohort
arm group label: Non-Obstructive Urinary Retention Cohort
arm group label: Overactive Bladder Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mylène Champs
role: Study Director
affiliation: Medtronic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Canada
country: France
country: Netherlands
country: Switzerland
country: United Kingdom
country: United States
country: Puerto Rico
responsible party type: Sponsor
mesh term: Fecal Incontinence
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Retention
sharing ipd: No