<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/NCT02978638</url>
  </required_header>
  <id_info>
    <org_study_id>CRE0004AGG</org_study_id>
    <secondary_id>W81XWH-14-2-0132</secondary_id>
    <nct_id>NCT02978638</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation for Continence After Spinal Cord Injury</brief_title>
  <official_title>Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Veterans Institute for Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Palo Alto Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Santa Clara Valley Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palo Alto Veterans Institute for Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to improve continence and voiding of patients with spinal cord injury using&#xD;
      electrical stimulation.&#xD;
&#xD;
      The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving&#xD;
      bladder and bowel function in patients with spinal cord injury (SCI). It has been&#xD;
      commercially available in Britain and other countries since 1982, and has been used in&#xD;
      thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA&#xD;
      approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing&#xD;
      urination on demand and to aid in bowel evacuation.&#xD;
&#xD;
      Electrical stimulation to produce bladder contraction and improve bladder voiding after&#xD;
      spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex&#xD;
      contraction of the bladder, which improves continence. However, cutting these nerves has&#xD;
      undesirable side effects. This study will not cut any sensory nerve. This study is testing&#xD;
      the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to&#xD;
      improve continence after spinal cord injury, and for blocking sphincter contraction to&#xD;
      improve voiding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Human subjects will be recruited from people with clinically complete spinal cord injury.&#xD;
&#xD;
      Subjects who meet the selection criteria described below will be screened to identify those&#xD;
      whose reflex bladder contractions are inhibited by neuromodulation using low levels of&#xD;
      electrical stimulation via electrodes on the skin over the dorsal genital nerve. Serial&#xD;
      filling cystometries will be performed in the clinical urodynamic laboratories at the study&#xD;
      sites. Bladder capacity and compliance will be recorded for each cytometrogram. Subjects&#xD;
      whose reflex bladder contractions are significantly inhibited by this neuromodulation will be&#xD;
      offered enrollment in the trial. Subjects whose reflex bladder contractions are not&#xD;
      significantly inhibited by this neuromodulation, or who do not wish to participate in the&#xD;
      study, will be able to continue with their usual form of bladder management.&#xD;
&#xD;
      After screening, selected subjects will be offered surgical implantation of a Vocare Bladder&#xD;
      System in the FDA-approved manner, but without posterior rhizotomy. Because posterior&#xD;
      rhizotomy is not performed, the afferent axons in the sacral nerves are intact and can be&#xD;
      stimulated after surgery via the electrodes connected to the implanted stimulator.&#xD;
&#xD;
      The Vocare Bladder System will be implanted in the FDA-approved manner but without posterior&#xD;
      rhizotomy.&#xD;
&#xD;
      After implantation, subjects will be evaluated in the urodynamic laboratory. Stimulation will&#xD;
      applied to S34 sacral nerves bilaterally, and the effects on bladder capacity and continence&#xD;
      and voiding will be measured.&#xD;
&#xD;
      Continence of urine will be documented by bladder diaries. These diaries will be completed&#xD;
      initially as an inpatient in the SCI Service and then at home while applying neuromodulation&#xD;
      via the implant.&#xD;
&#xD;
      It is expected that sacral neuromodulation by this method will be associated with a&#xD;
      significant increase in bladder capacity and continence.&#xD;
&#xD;
      It is possible that this neuromodulation will not be associated with an increase in bladder&#xD;
      capacity or continence. If so, subjects will still be able to use conventional methods of&#xD;
      managing continence and should have no loss of function.&#xD;
&#xD;
      Participants whose bladder capacity and continence are improved by neuromodulation using the&#xD;
      implanted stimulator will be offered the opportunity to continue to use the stimulator for&#xD;
      the duration of the study and will be reviewed at three-month intervals. At the end of the&#xD;
      study they will be reviewed again with their usual clinician and if there are no&#xD;
      contra-indications to continued use of the stimulator will be offered the opportunity to&#xD;
      continue its use under continued clinical follow-up from their usual clinician.&#xD;
&#xD;
      Participants whose bladder capacity and continence are not improved by neuromodulation using&#xD;
      the implanted stimulator, or who do not wish to continue using the implanted stimulator, will&#xD;
      be reviewed with their usual clinician and offered the bladder management they were using&#xD;
      prior to the study. The implanted stimulator will be switched off, but will not be removed&#xD;
      unless the participant wishes it to be removed or the investigators or the participant's&#xD;
      usual clinician consider it in the participant's interest to be removed. It is usually&#xD;
      simpler and safer for the participant to leave the stimulator implanted but inactive.&#xD;
&#xD;
      All participants will be provided with appropriate documentation regarding safety and&#xD;
      electromagnetic compatibility of the device.&#xD;
&#xD;
      The investigation is justified because the potential benefits are greater than the potential&#xD;
      risks, as follows:&#xD;
&#xD;
      The potential benefit of the research to the subjects are:&#xD;
&#xD;
        1. Improved bladder capacity&#xD;
&#xD;
        2. Improved continence&#xD;
&#xD;
      The potential benefits of the research to others are:&#xD;
&#xD;
      Evidence that bladder capacity and continence after spinal cord injury can be improved by&#xD;
      electrical stimulation without cutting nerves.&#xD;
&#xD;
      The risks to subjects are reasonable in relation to the anticipated benefits to subjects and&#xD;
      others because of&#xD;
&#xD;
        1. The high prevalence and severity of clinical complications caused by bladder&#xD;
           complications after spinal cord injury&#xD;
&#xD;
        2. The paucity of methods of restoring continence after spinal cord injury that are safe,&#xD;
           effective and without undesirable side effects&#xD;
&#xD;
      This study is primarily aimed at demonstrating safety, feasibility and proof of concept. It&#xD;
      may also produce statistically and clinically significant evidence of efficacy that can be&#xD;
      used to plan future clinical trials.&#xD;
&#xD;
      Significance:&#xD;
&#xD;
      If the technique of reducing reflex bladder contraction by implanted stimulation of the S34&#xD;
      nerve bilaterally is successful, it will open the door to more effective use of&#xD;
      neuromodulation for continence after spinal cord injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</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>Bladder capacity</measure>
    <time_frame>Change from baseline bladder capacity at 12-month follow-up visit</time_frame>
    <description>Bladder capacity (ml.) measured during filling cystometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of incontinence of urine</measure>
    <time_frame>Change from baseline frequency of incontinence of urine at 12-month follow-up visit</time_frame>
    <description>Frequency of incontinence determined from diary data collected by the subjects</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Neurogenic Bladder</condition>
  <condition>Incontinence</condition>
  <arm_group>
    <arm_group_label>Finetech Vocare Bladder System</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This is a pilot study of the Finetech Vocare Bladder System to improve continence and voiding in human subjects with chronic spinal cord injury. Each subject will act as their own control, comparing function with the Finetech Vocare Bladder System in use and not in use.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Finetech Vocare Bladder System</intervention_name>
    <description>Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.</description>
    <arm_group_label>Finetech Vocare Bladder System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects will be included if they meet all of the following criteria:&#xD;
&#xD;
          -  Complete spinal cord injury (AIS grade A) of at least 2 years duration with&#xD;
             neurological level (ISNCSCI level) below C4&#xD;
&#xD;
          -  Impaired bladder emptying due to Detrusor External Sphincter Dyssynergia-DESD&#xD;
             (unco-ordinated contraction of bladder and external urethral sphincter) as shown on&#xD;
             video-urodynamic testing.&#xD;
&#xD;
          -  Impaired continence due to detrusor hyper-reflexia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if they meet any of the following criteria:&#xD;
&#xD;
          -  Absence of reflex contractions of the bladder as shown on urodynamic testing&#xD;
&#xD;
          -  Absence of reflex contractions of the external urethral sphincter as shown on&#xD;
             urodynamic testing with EMG&#xD;
&#xD;
          -  External sphincterotomy, urethral stricture or previous urethral or sphincter or&#xD;
             bladder or prostate surgery&#xD;
&#xD;
          -  History of pelvic fracture&#xD;
&#xD;
          -  Subjects on anticoagulants or with coagulation disorders&#xD;
&#xD;
          -  Immunosuppressed subjects&#xD;
&#xD;
          -  Active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric&#xD;
             areas&#xD;
&#xD;
          -  Active untreated infection&#xD;
&#xD;
          -  Active implanted medical device such as cardiac pacemaker or defibrillator&#xD;
&#xD;
          -  Progressive spinal cord injury&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Mechanical ventilator dependency&#xD;
&#xD;
          -  Any other significant co-morbidity or illness that would preclude their participation&#xD;
             or increase the risk to them of participating in the study&#xD;
&#xD;
          -  Inability or unwillingness to follow study protocol or give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Graham H. Creasey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palo Alto Veterans Institute for Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reza Ehsanian, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Graham H. Creasey, MD</last_name>
    <phone>650-704-2394</phone>
    <email>gcreasey@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zoia Latev, PhD</last_name>
    <phone>408-348-7740</phone>
    <email>latev.mail@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Palo Alto Veterans Institute for Research</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Graham Creasey, MD</last_name>
      <phone>650-704-2394</phone>
      <phone_ext>65040</phone_ext>
      <email>gcreasey@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Zoia Latev, PhD</last_name>
      <phone>408-348-7740</phone>
      <email>latev.mail@gmail.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Santa Clara Valley Medical Center</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Harminder Singh, MD</last_name>
      <phone>408-885-4646</phone>
      <email>harminder.singh@hhs.sccgov.org</email>
    </contact>
    <contact_backup>
      <last_name>Michael Prutton</last_name>
      <phone>4088853961</phone>
      <email>michael.prutton@hhs.sccgov.org</email>
    </contact_backup>
    <investigator>
      <last_name>Harminder Singh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christopher Elliott, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Reza Ehsanian, MD, PhD</last_name>
      <phone>408-687-8206</phone>
      <email>rezaehsanian@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dennis Bourbeau, PhD</last_name>
      <email>dbourbeau@fescenter.org</email>
    </contact>
    <contact_backup>
      <last_name>Kimberly Schach</last_name>
      <email>kschach@metrohealth.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Creasey GH, Grill JH, Korsten M, U HS, Betz R, Anderson R, Walter J; Implanted Neuroprosthesis Research Group. An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch Phys Med Rehabil. 2001 Nov;82(11):1512-9. doi: 10.1053/apmr.2001.25911.</citation>
    <PMID>11689969</PMID>
  </reference>
  <reference>
    <citation>Kirkham AP, Knight SL, Craggs MD, Casey AT, Shah PJ. Neuromodulation through sacral nerve roots 2 to 4 with a Finetech-Brindley sacral posterior and anterior root stimulator. Spinal Cord. 2002 Jun;40(6):272-81. doi: 10.1038/sj.sc.3101278.</citation>
    <PMID>12037708</PMID>
  </reference>
  <reference>
    <citation>Kutzenberger J, Domurath B, Sauerwein D. Spastic bladder and spinal cord injury: seventeen years of experience with sacral deafferentation and implantation of an anterior root stimulator. Artif Organs. 2005 Mar;29(3):239-41. doi: 10.1111/j.1525-1594.2005.29043.x.</citation>
    <PMID>15725225</PMID>
  </reference>
  <reference>
    <citation>Martens FM, den Hollander PP, Snoek GJ, Koldewijn EL, van Kerrebroeck PE, Heesakkers JP. Quality of life in complete spinal cord injury patients with a Brindley bladder stimulator compared to a matched control group. Neurourol Urodyn. 2011 Apr;30(4):551-5. doi: 10.1002/nau.21012. Epub 2011 Feb 15.</citation>
    <PMID>21328472</PMID>
  </reference>
  <reference>
    <citation>Martens FM, Heesakkers JP. Clinical results of a brindley procedure: sacral anterior root stimulation in combination with a rhizotomy of the dorsal roots. Adv Urol. 2011;2011:709708. doi: 10.1155/2011/709708. Epub 2011 Jun 22.</citation>
    <PMID>21738530</PMID>
  </reference>
  <reference>
    <citation>Rasmussen MM, Kutzenberger J, Krogh K, Zepke F, Bodin C, Domurath B, Christensen P. Sacral anterior root stimulation improves bowel function in subjects with spinal cord injury. Spinal Cord. 2015 Apr;53(4):297-301. doi: 10.1038/sc.2015.2. Epub 2015 Jan 20.</citation>
    <PMID>25600307</PMID>
  </reference>
  <reference>
    <citation>Schurch B, Rodic B, Jeanmonod D. Posterior sacral rhizotomy and intradural anterior sacral root stimulation for treatment of the spastic bladder in spinal cord injured patients. J Urol. 1997 Feb;157(2):610-4.</citation>
    <PMID>8996369</PMID>
  </reference>
  <reference>
    <citation>van der Aa HE, Alleman E, Nene A, Snoek G. Sacral anterior root stimulation for bladder control: clinical results. Arch Physiol Biochem. 1999 Jul;107(3):248-56. doi: 10.1076/apab.107.3.248.4330.</citation>
    <PMID>10650355</PMID>
  </reference>
  <reference>
    <citation>Van Kerrebroeck PE, Koldewijn EL, Rosier PF, Wijkstra H, Debruyne FM. Results of the treatment of neurogenic bladder dysfunction in spinal cord injury by sacral posterior root rhizotomy and anterior sacral root stimulation. J Urol. 1996 Apr;155(4):1378-81. doi: 10.1097/00005392-199604000-00069.</citation>
    <PMID>8632580</PMID>
  </reference>
  <reference>
    <citation>Vastenholt JM, Snoek GJ, Buschman HP, van der Aa HE, Alleman ER, Ijzerman MJ. A 7-year follow-up of sacral anterior root stimulation for bladder control in patients with a spinal cord injury: quality of life and users' experiences. Spinal Cord. 2003 Jul;41(7):397-402. doi: 10.1038/sj.sc.3101465.</citation>
    <PMID>12815371</PMID>
  </reference>
  <reference>
    <citation>Wielink G, Essink-Bot ML, van Kerrebroeck PE, Rutten FF. Sacral rhizotomies and electrical bladder stimulation in spinal cord injury. 2. Cost-effectiveness and quality of life analysis. Dutch Study Group on Sacral Anterior Root Stimulation. Eur Urol. 1997;31(4):441-6. doi: 10.1159/000474504.</citation>
    <PMID>9187905</PMID>
  </reference>
  <reference>
    <citation>Kirkham AP, Shah NC, Knight SL, Shah PJ, Craggs MD. The acute effects of continuous and conditional neuromodulation on the bladder in spinal cord injury. Spinal Cord. 2001 Aug;39(8):420-8. doi: 10.1038/sj.sc.3101177.</citation>
    <PMID>11512072</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 18, 2022</last_update_submitted>
  <last_update_submitted_qc>April 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Palo Alto Veterans Institute for Research</investigator_affiliation>
    <investigator_full_name>Graham Creasey</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Spinal cord injury</keyword>
  <keyword>Bladder capacity</keyword>
  <keyword>Electrical stimulation</keyword>
  <keyword>Continence</keyword>
  <keyword>Urodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Urinary Bladder, Neurogenic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02978638
org study id: CRE0004AGG
secondary id: W81XWH-14-2-0132
nct id: NCT02978638
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study aims to improve continence and voiding of patients with spinal cord injury using
      electrical stimulation.

      The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving
      bladder and bowel function in patients with spinal cord injury (SCI). It has been
      commercially available in Britain and other countries since 1982, and has been used in
      thousands of patients with SCI to improve bladder, bowel and sexual function. It received FDA
      approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing
      urination on demand and to aid in bowel evacuation.

      Electrical stimulation to produce bladder contraction and improve bladder voiding after
      spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex
      contraction of the bladder, which improves continence. However, cutting these nerves has
      undesirable side effects. This study will not cut any sensory nerve. This study is testing
      the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to
      improve continence after spinal cord injury, and for blocking sphincter contraction to
      improve voiding.
Human subjects will be recruited from people with clinically complete spinal cord injury.

      Subjects who meet the selection criteria described below will be screened to identify those
      whose reflex bladder contractions are inhibited by neuromodulation using low levels of
      electrical stimulation via electrodes on the skin over the dorsal genital nerve. Serial
      filling cystometries will be performed in the clinical urodynamic laboratories at the study
      sites. Bladder capacity and compliance will be recorded for each cytometrogram. Subjects
      whose reflex bladder contractions are significantly inhibited by this neuromodulation will be
      offered enrollment in the trial. Subjects whose reflex bladder contractions are not
      significantly inhibited by this neuromodulation, or who do not wish to participate in the
      study, will be able to continue with their usual form of bladder management.

      After screening, selected subjects will be offered surgical implantation of a Vocare Bladder
      System in the FDA-approved manner, but without posterior rhizotomy. Because posterior
      rhizotomy is not performed, the afferent axons in the sacral nerves are intact and can be
      stimulated after surgery via the electrodes connected to the implanted stimulator.

      The Vocare Bladder System will be implanted in the FDA-approved manner but without posterior
      rhizotomy.

      After implantation, subjects will be evaluated in the urodynamic laboratory. Stimulation will
      applied to S34 sacral nerves bilaterally, and the effects on bladder capacity and continence
      and voiding will be measured.

      Continence of urine will be documented by bladder diaries. These diaries will be completed
      initially as an inpatient in the SCI Service and then at home while applying neuromodulation
      via the implant.

      It is expected that sacral neuromodulation by this method will be associated with a
      significant increase in bladder capacity and continence.

      It is possible that this neuromodulation will not be associated with an increase in bladder
      capacity or continence. If so, subjects will still be able to use conventional methods of
      managing continence and should have no loss of function.

      Participants whose bladder capacity and continence are improved by neuromodulation using the
      implanted stimulator will be offered the opportunity to continue to use the stimulator for
      the duration of the study and will be reviewed at three-month intervals. At the end of the
      study they will be reviewed again with their usual clinician and if there are no
      contra-indications to continued use of the stimulator will be offered the opportunity to
      continue its use under continued clinical follow-up from their usual clinician.

      Participants whose bladder capacity and continence are not improved by neuromodulation using
      the implanted stimulator, or who do not wish to continue using the implanted stimulator, will
      be reviewed with their usual clinician and offered the bladder management they were using
      prior to the study. The implanted stimulator will be switched off, but will not be removed
      unless the participant wishes it to be removed or the investigators or the participant's
      usual clinician consider it in the participant's interest to be removed. It is usually
      simpler and safer for the participant to leave the stimulator implanted but inactive.

      All participants will be provided with appropriate documentation regarding safety and
      electromagnetic compatibility of the device.

      The investigation is justified because the potential benefits are greater than the potential
      risks, as follows:

      The potential benefit of the research to the subjects are:

        1. Improved bladder capacity

        2. Improved continence

      The potential benefits of the research to others are:

      Evidence that bladder capacity and continence after spinal cord injury can be improved by
      electrical stimulation without cutting nerves.

      The risks to subjects are reasonable in relation to the anticipated benefits to subjects and
      others because of

        1. The high prevalence and severity of clinical complications caused by bladder
           complications after spinal cord injury

        2. The paucity of methods of restoring continence after spinal cord injury that are safe,
           effective and without undesirable side effects

      This study is primarily aimed at demonstrating safety, feasibility and proof of concept. It
      may also produce statistically and clinically significant evidence of efficacy that can be
      used to plan future clinical trials.

      Significance:

      If the technique of reducing reflex bladder contraction by implanted stimulation of the S34
      nerve bilaterally is successful, it will open the door to more effective use of
      neuromodulation for continence after spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Bladder capacity
time frame: Change from baseline bladder capacity at 12-month follow-up visit
description: Bladder capacity (ml.) measured during filling cystometry
measure: Frequency of incontinence of urine
time frame: Change from baseline frequency of incontinence of urine at 12-month follow-up visit
description: Frequency of incontinence determined from diary data collected by the subjects
arm group label: Finetech Vocare Bladder System
arm group type: Other
description: This is a pilot study of the Finetech Vocare Bladder System to improve continence and voiding in human subjects with chronic spinal cord injury. Each subject will act as their own control, comparing function with the Finetech Vocare Bladder System in use and not in use.
intervention type: Device
intervention name: Finetech Vocare Bladder System
description: Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.
arm group label: Finetech Vocare Bladder System
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: No
last name: Graham H. Creasey, MD
role: Principal Investigator
affiliation: Palo Alto Veterans Institute for Research
last name: Reza Ehsanian, MD PhD
role: Study Director
affiliation: University of New Mexico
last name: Graham H. Creasey, MD
phone: 650-704-2394
email: gcreasey@stanford.edu
last name: Zoia Latev, PhD
phone: 408-348-7740
email: latev.mail@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Creasey GH, Grill JH, Korsten M, U HS, Betz R, Anderson R, Walter J; Implanted Neuroprosthesis Research Group. An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: a multicenter trial. Arch Phys Med Rehabil. 2001 Nov;82(11):1512-9. doi: 10.1053/apmr.2001.25911.
PMID: 11689969
citation: Kirkham AP, Knight SL, Craggs MD, Casey AT, Shah PJ. Neuromodulation through sacral nerve roots 2 to 4 with a Finetech-Brindley sacral posterior and anterior root stimulator. Spinal Cord. 2002 Jun;40(6):272-81. doi: 10.1038/sj.sc.3101278.
PMID: 12037708
citation: Kutzenberger J, Domurath B, Sauerwein D. Spastic bladder and spinal cord injury: seventeen years of experience with sacral deafferentation and implantation of an anterior root stimulator. Artif Organs. 2005 Mar;29(3):239-41. doi: 10.1111/j.1525-1594.2005.29043.x.
PMID: 15725225
citation: Martens FM, den Hollander PP, Snoek GJ, Koldewijn EL, van Kerrebroeck PE, Heesakkers JP. Quality of life in complete spinal cord injury patients with a Brindley bladder stimulator compared to a matched control group. Neurourol Urodyn. 2011 Apr;30(4):551-5. doi: 10.1002/nau.21012. Epub 2011 Feb 15.
PMID: 21328472
citation: Martens FM, Heesakkers JP. Clinical results of a brindley procedure: sacral anterior root stimulation in combination with a rhizotomy of the dorsal roots. Adv Urol. 2011;2011:709708. doi: 10.1155/2011/709708. Epub 2011 Jun 22.
PMID: 21738530
citation: Rasmussen MM, Kutzenberger J, Krogh K, Zepke F, Bodin C, Domurath B, Christensen P. Sacral anterior root stimulation improves bowel function in subjects with spinal cord injury. Spinal Cord. 2015 Apr;53(4):297-301. doi: 10.1038/sc.2015.2. Epub 2015 Jan 20.
PMID: 25600307
citation: Schurch B, Rodic B, Jeanmonod D. Posterior sacral rhizotomy and intradural anterior sacral root stimulation for treatment of the spastic bladder in spinal cord injured patients. J Urol. 1997 Feb;157(2):610-4.
PMID: 8996369
citation: van der Aa HE, Alleman E, Nene A, Snoek G. Sacral anterior root stimulation for bladder control: clinical results. Arch Physiol Biochem. 1999 Jul;107(3):248-56. doi: 10.1076/apab.107.3.248.4330.
PMID: 10650355
citation: Van Kerrebroeck PE, Koldewijn EL, Rosier PF, Wijkstra H, Debruyne FM. Results of the treatment of neurogenic bladder dysfunction in spinal cord injury by sacral posterior root rhizotomy and anterior sacral root stimulation. J Urol. 1996 Apr;155(4):1378-81. doi: 10.1097/00005392-199604000-00069.
PMID: 8632580
citation: Vastenholt JM, Snoek GJ, Buschman HP, van der Aa HE, Alleman ER, Ijzerman MJ. A 7-year follow-up of sacral anterior root stimulation for bladder control in patients with a spinal cord injury: quality of life and users' experiences. Spinal Cord. 2003 Jul;41(7):397-402. doi: 10.1038/sj.sc.3101465.
PMID: 12815371
citation: Wielink G, Essink-Bot ML, van Kerrebroeck PE, Rutten FF. Sacral rhizotomies and electrical bladder stimulation in spinal cord injury. 2. Cost-effectiveness and quality of life analysis. Dutch Study Group on Sacral Anterior Root Stimulation. Eur Urol. 1997;31(4):441-6. doi: 10.1159/000474504.
PMID: 9187905
citation: Kirkham AP, Shah NC, Knight SL, Shah PJ, Craggs MD. The acute effects of continuous and conditional neuromodulation on the bladder in spinal cord injury. Spinal Cord. 2001 Aug;39(8):420-8. doi: 10.1038/sj.sc.3101177.
PMID: 11512072
responsible party type: Principal Investigator
investigator affiliation: Palo Alto Veterans Institute for Research
investigator full name: Graham Creasey
investigator title: Professor
mesh term: Spinal Cord Injuries
mesh term: Urinary Bladder, Neurogenic
mesh term: Wounds and Injuries
sharing ipd: Undecided