<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/NCT03019094</url>
  </required_header>
  <id_info>
    <org_study_id>G01-CLP-0001</org_study_id>
    <nct_id>NCT03019094</nct_id>
  </id_info>
  <brief_title>Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1</brief_title>
  <acronym>OPTIMIST-1</acronym>
  <official_title>Safety and Performance of the BlueWind RENOVA™ System for the Treatment of Patients Diagnosed With Overactive Bladder (OAB) (OPTIMIST-1 - Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BlueWind Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BlueWind Medical</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Interventional, Prospective, Open Label study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Generally, subjects will be followed at 1, 2, 3, 4, 6, 9 and 12-months after activation with&#xD;
      the RENOVA System.&#xD;
&#xD;
      The study will be conducted according the following phases:&#xD;
&#xD;
        -  Recruitment, baseline assessment and compatibility test: Subjects fulfilling all&#xD;
           inclusion and none of the exclusion criteria will be enrolled to the trial. Study&#xD;
           candidates will sign an informed consent form, complete a standard 3-Day voiding diary,&#xD;
           a quality of life questionnaire and global response assessment. Beck Depression&#xD;
           Inventory II and General quality of life questionnaires will be completed in selected&#xD;
           geographies. Study eligible subjects that have not experienced Posterior Tibial Nerve&#xD;
           Stimulation treatment in the past will undergo a compatibility test to assure proper&#xD;
           nerve conductivity. Data collected will serve as baseline.&#xD;
&#xD;
        -  Implantation: Patients with positive response to the compatibility test (or that&#xD;
           received Posterior Tibial Nerve Stimulation treatment in the past) will undergo&#xD;
           unilateral implantation 4±1 weeks following recruitment with the BlueWind RENOVA System.&#xD;
           Intra-operative sensory/motor response will be tested to confirm accurate location of&#xD;
           the implant.&#xD;
&#xD;
        -  Sensation assessment and activation: After a recovery period of approximately 30±7 days,&#xD;
           subjects will complete a Brief 3-Day voiding diary and a quality of life questionnaire&#xD;
           and a sensation assessment will be conducted: subjects will undergo an acute stimulation&#xD;
           session of the tibial nerve to evaluate their sensory reaction to stimulation and&#xD;
           parameters setting will be performed according to their individual sensations.&#xD;
           Eventually, patients will be trained for system home use treatment. Therapy will be&#xD;
           delivered daily for a minimum of 30 minutes once a day and maximum of 1 hour per day (in&#xD;
           2 sessions of 30 minutes), per physician discretion. Following activation of the device,&#xD;
           patient will complete Brief 3-day voiding diaries once a week until the 1 month&#xD;
           follow-up visit.&#xD;
&#xD;
        -  Follow-ups (1-, 2-, and 3-months post-device activation): A 3-Day voiding diary and QoL&#xD;
           questionnaire will be collected (brief 3-Day diaries on 1-, and 2-months follow up&#xD;
           visits; and a 3-Day standard voiding diary on the 3-month follow up). Global Response&#xD;
           Assessment and Beck Depression Inventory II will be collected on the 3-month follow-up&#xD;
           visit (Beck Depression Inventory in selected geographies). Stimulation parameters will&#xD;
           be checked and adjusted as needed by: (a) changing current amplitude; and/or (b)&#xD;
           changing stimulation frequency; and/or changing pulse width; and/or (c) changing the&#xD;
           number of daily treatment sessions. Location of paresthesia will be recorded in each of&#xD;
           the clinic visits. The visit at 2 months will be performed by phone call to assess the&#xD;
           patient status. Clinic visit may be followed at the discretion of the clinical team.&#xD;
&#xD;
        -  Continued follow-ups: All subjects in the trial will undergo 4 additional visits (at 4-,&#xD;
           6- ,9- and 12-months post-device activation) until the end of the study at the 12-month&#xD;
           visit. Similar to the visit at 2 months, the visit at 4 months will be performed by&#xD;
           phone call to assess the patient status. Clinic visit may be followed at the discretion&#xD;
           of the clinical team. Three-Day voiding diary, Quality of Life questionnaire, Global&#xD;
           Response Assessment and Beck Depression Inventory II and General quality of life&#xD;
           questionnaires (at selected geographies) will be collected at each of those visits&#xD;
           (except for the 4- and 9-months visit in which only a 3-Day Brief voiding diary will be&#xD;
           collected). General quality of life questionnaire will be completed at the 12-month&#xD;
           visit in selected geographies. Stimulation parameters will be checked and adjusted as&#xD;
           needed. Location of paresthesia will be recorded in each of the clinic visits&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Incidence of serious adverse events</measure>
    <time_frame>6 and 12 months post-activation</time_frame>
    <description>Incidence of serious adverse events (system and/or procedure related events)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement in urge urinary incontinence</measure>
    <time_frame>3 months post-activation</time_frame>
    <description>Change from baseline in number of leaking episodes per day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement urinary frequency</measure>
    <time_frame>3 months post-activation</time_frame>
    <description>Change from baseline in number of voids per day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical improvement in degree of urgency</measure>
    <time_frame>3 months post-activation</time_frame>
    <description>Change from baseline in degree of urgency prior to void</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in number of leaking episodes</measure>
    <time_frame>6- and 12 months post activation</time_frame>
    <description>Change from baseline in number of leaking episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of voids</measure>
    <time_frame>6- and 12 months post activation</time_frame>
    <description>Change from baseline in number of voids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in degree of urgency prior to void</measure>
    <time_frame>6- and 12 months post activation</time_frame>
    <description>Change from baseline in degree of urgency prior to void</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in number of absorbent pads</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline in number of Absorbent pads used due to leaking/day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in volume voided per void</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline of Volume voided/void</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urge urinary incontinence episodes</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline in severity of leaking episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline in quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Global response of patient to treatment</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline in global response assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depression indices</measure>
    <time_frame>3, 6, and 12 months post activation</time_frame>
    <description>Change from baseline in Beck Depression Inventory II</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of the RENOVA tibial nerve stimulation system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The RENOVA tibial nerve stimulation system</intervention_name>
    <description>Study participants will be implanted with the RENOVA tibial nerve stimulation system</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed written informed consent.&#xD;
&#xD;
          2. Patient who is mentally competent with the ability to understand and comply with the&#xD;
             requirements of the study.&#xD;
&#xD;
          3. Patient agrees to attend all follow-up evaluations and is willing to completely and&#xD;
             accurately fill out voiding diaries and questionnaires, and is willing to complete&#xD;
             required exams and tests.&#xD;
&#xD;
          4. Patients with overactive bladder symptoms including:&#xD;
&#xD;
               -  Urinary frequency greater than or equal to 8 voids/24 hours and less than 16&#xD;
                  voids/24 hours AND/OR&#xD;
&#xD;
               -  Urinary urge incontinence of at least 2 incontinence episodes on a 3-Day voiding&#xD;
                  diary&#xD;
&#xD;
          5. If used, patients should be on stable dose of antimuscarinics and/or beta-3 adrenergic&#xD;
             agonists for at least 6 weeks prior to enrollment and agree not to change their dose&#xD;
             until the 3-month follow-up visit.&#xD;
&#xD;
          6. If used, patients should be on a stable dose of tricyclic antidepressants and Flomax&#xD;
             for at least 6 weeks prior to enrollment and agree not to change their dose until the&#xD;
             3-month follow-up visit.&#xD;
&#xD;
          7. Patient who has failed conservative treatments after at least 6 months of treatment&#xD;
             (i.e. lifestyle modification-fluid consumption, behavioral modification, and&#xD;
             pharmacological therapy).&#xD;
&#xD;
          8. Patients with no clinical evidence of a tibial motor sensory deficit.&#xD;
&#xD;
          9. Patients with competent sphincter mechanism.&#xD;
&#xD;
         10. Patients with normally functioning upper urinary tract and no renal failure.&#xD;
&#xD;
         11. Leg circumference in the range of 20-30 cm at implantation site.&#xD;
&#xD;
         12. Patients with a standard 3-Day voiding diary at baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous participation in another study with any investigational drug or device within&#xD;
             the past 90 days.&#xD;
&#xD;
          2. Any metal or other implant in the area of BlueWind RENOVA implantation site.&#xD;
&#xD;
          3. Patients who have not had stable OAB medications for at least 6 weeks.&#xD;
&#xD;
          4. Patients with neurogenic bladder.&#xD;
&#xD;
          5. Patients who are taking diuretics.&#xD;
&#xD;
          6. Patients who have received botulinum toxin injections within the past 12 months.&#xD;
&#xD;
          7. Patients who have received or are receiving nerve stimulation therapies for OAB&#xD;
             treatment, including Sacral Nerve Stimulation (and are still implanted) or Posterior&#xD;
             Tibial Nerve Stimulation (during the last 3 months).&#xD;
&#xD;
          8. Current pregnancy or attempting to get pregnant.&#xD;
&#xD;
          9. Previous urinary incontinence surgery or implantation of artificial graft material.&#xD;
&#xD;
         10. Any spinal or genitourinary surgery within the last 6 months.&#xD;
&#xD;
         11. Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/&#xD;
             prostatectomy (male).&#xD;
&#xD;
         12. Skin, orthopedic or neurologic anatomical limitations that preclude implantation&#xD;
             or/and use of the device.&#xD;
&#xD;
         13. Pelvic pain disorders.&#xD;
&#xD;
         14. Obvious clinically demonstrated genuine stress incontinence including mixed&#xD;
             incontinence.&#xD;
&#xD;
         15. Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple&#xD;
             Sclerosis, neuropathy or injury resulting in neuropathy.&#xD;
&#xD;
         16. Current or recurrent urinary tract infection (3 or more infections in the last 6&#xD;
             months), or urinary tract obstruction such as benign prostatic hypertrophy, cancer,&#xD;
             urethral stricture or presence of urinary stone.&#xD;
&#xD;
         17. History of Pelvic radiotherapy and chemotherapy.&#xD;
&#xD;
         18. Severe uncontrolled diabetes.&#xD;
&#xD;
         19. Patients anticipating magnetic resonance imaging (MRI) exams that are not allowed in&#xD;
             the device labeling.&#xD;
&#xD;
         20. Presence of cystocele, enterocele or rectocele of grade 2 or more.&#xD;
&#xD;
         21. Patients with a documented history of allergic response to Platinum iridium, Titanium,&#xD;
             Zirconia and Parylene.&#xD;
&#xD;
         22. Another active implant.&#xD;
&#xD;
         23. Have a life expectancy of less than 1 year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 15, 2017</last_update_submitted>
  <last_update_submitted_qc>May 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>overactive bladder</keyword>
  <keyword>urge urinary incontinence</keyword>
  <keyword>urgency frequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <!-- 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/NCT03019094
org study id: G01-CLP-0001
nct id: NCT03019094
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Interventional, Prospective, Open Label study
Generally, subjects will be followed at 1, 2, 3, 4, 6, 9 and 12-months after activation with
      the RENOVA System.

      The study will be conducted according the following phases:

        -  Recruitment, baseline assessment and compatibility test: Subjects fulfilling all
           inclusion and none of the exclusion criteria will be enrolled to the trial. Study
           candidates will sign an informed consent form, complete a standard 3-Day voiding diary,
           a quality of life questionnaire and global response assessment. Beck Depression
           Inventory II and General quality of life questionnaires will be completed in selected
           geographies. Study eligible subjects that have not experienced Posterior Tibial Nerve
           Stimulation treatment in the past will undergo a compatibility test to assure proper
           nerve conductivity. Data collected will serve as baseline.

        -  Implantation: Patients with positive response to the compatibility test (or that
           received Posterior Tibial Nerve Stimulation treatment in the past) will undergo
           unilateral implantation 4±1 weeks following recruitment with the BlueWind RENOVA System.
           Intra-operative sensory/motor response will be tested to confirm accurate location of
           the implant.

        -  Sensation assessment and activation: After a recovery period of approximately 30±7 days,
           subjects will complete a Brief 3-Day voiding diary and a quality of life questionnaire
           and a sensation assessment will be conducted: subjects will undergo an acute stimulation
           session of the tibial nerve to evaluate their sensory reaction to stimulation and
           parameters setting will be performed according to their individual sensations.
           Eventually, patients will be trained for system home use treatment. Therapy will be
           delivered daily for a minimum of 30 minutes once a day and maximum of 1 hour per day (in
           2 sessions of 30 minutes), per physician discretion. Following activation of the device,
           patient will complete Brief 3-day voiding diaries once a week until the 1 month
           follow-up visit.

        -  Follow-ups (1-, 2-, and 3-months post-device activation): A 3-Day voiding diary and QoL
           questionnaire will be collected (brief 3-Day diaries on 1-, and 2-months follow up
           visits; and a 3-Day standard voiding diary on the 3-month follow up). Global Response
           Assessment and Beck Depression Inventory II will be collected on the 3-month follow-up
           visit (Beck Depression Inventory in selected geographies). Stimulation parameters will
           be checked and adjusted as needed by: (a) changing current amplitude; and/or (b)
           changing stimulation frequency; and/or changing pulse width; and/or (c) changing the
           number of daily treatment sessions. Location of paresthesia will be recorded in each of
           the clinic visits. The visit at 2 months will be performed by phone call to assess the
           patient status. Clinic visit may be followed at the discretion of the clinical team.

        -  Continued follow-ups: All subjects in the trial will undergo 4 additional visits (at 4-,
           6- ,9- and 12-months post-device activation) until the end of the study at the 12-month
           visit. Similar to the visit at 2 months, the visit at 4 months will be performed by
           phone call to assess the patient status. Clinic visit may be followed at the discretion
           of the clinical team. Three-Day voiding diary, Quality of Life questionnaire, Global
           Response Assessment and Beck Depression Inventory II and General quality of life
           questionnaires (at selected geographies) will be collected at each of those visits
           (except for the 4- and 9-months visit in which only a 3-Day Brief voiding diary will be
           collected). General quality of life questionnaire will be completed at the 12-month
           visit in selected geographies. Stimulation parameters will be checked and adjusted as
           needed. Location of paresthesia will be recorded in each of the clinic visits
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of serious adverse events
time frame: 6 and 12 months post-activation
description: Incidence of serious adverse events (system and/or procedure related events)
measure: Clinical improvement in urge urinary incontinence
time frame: 3 months post-activation
description: Change from baseline in number of leaking episodes per day
measure: Clinical improvement urinary frequency
time frame: 3 months post-activation
description: Change from baseline in number of voids per day
measure: Clinical improvement in degree of urgency
time frame: 3 months post-activation
description: Change from baseline in degree of urgency prior to void
measure: Change in number of leaking episodes
time frame: 6- and 12 months post activation
description: Change from baseline in number of leaking episodes
measure: Change in number of voids
time frame: 6- and 12 months post activation
description: Change from baseline in number of voids
measure: Change in degree of urgency prior to void
time frame: 6- and 12 months post activation
description: Change from baseline in degree of urgency prior to void
measure: Change in number of absorbent pads
time frame: 3, 6, and 12 months post activation
description: Change from baseline in number of Absorbent pads used due to leaking/day
measure: Change in volume voided per void
time frame: 3, 6, and 12 months post activation
description: Change from baseline of Volume voided/void
measure: Change in urge urinary incontinence episodes
time frame: 3, 6, and 12 months post activation
description: Change from baseline in severity of leaking episodes
measure: Change in Quality of Life
time frame: 3, 6, and 12 months post activation
description: Change from baseline in quality of life
measure: Change in Global response of patient to treatment
time frame: 3, 6, and 12 months post activation
description: Change from baseline in global response assessment
measure: Change in Depression indices
time frame: 3, 6, and 12 months post activation
description: Change from baseline in Beck Depression Inventory II
arm group label: Treatment
arm group type: Experimental
description: Implantation of the RENOVA tibial nerve stimulation system
intervention type: Device
intervention name: The RENOVA tibial nerve stimulation system
description: Study participants will be implanted with the RENOVA tibial nerve stimulation system
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive