xml: <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/NCT05968352</url>
    </required_header>
    <id_info>
      <org_study_id>IRAS 260021</org_study_id>
      <nct_id>NCT05968352</nct_id>
    </id_info>
    <brief_title>Restoration of Bladder Function in Spinal Cord Injury</brief_title>
    <official_title>Restoration of Bladder Function in Spinal Cord Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Oxford</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Oxford</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of this study is to develop improved methods of restoring function to the neurogenic&#xD;
        bladder, using electrical stimulation without cutting nerves in patients with spinal cord&#xD;
        injury.&#xD;
  &#xD;
        The investigators will test 5-10 subjects with existing sacral anterior root stimulation&#xD;
        (SARS) devices and look at the effects of high frequency (up to 600Hz) compared to the usual&#xD;
        low frequency stimulation on bladder function. The investigators are particularly interested&#xD;
        in whether it is possible to reproduce a 'functional' dorzal rhizotomy using high frequency&#xD;
        stimulation of the S2 efferent nerves&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a proof of concept study of the effects on the urinary bladder and sphincter of high&#xD;
        frequency stimuli applied to sacral efferent nerves. The effects on the bladder of low&#xD;
        frequency stimuli applied to sacral afferent nerves will also be studied. It is also part of&#xD;
        an academic collaboration between Oxford and Stanford University. The results will not be&#xD;
        sold to Stanford but will be shared to enhance the development of therapies for patients with&#xD;
        spinal cord injury. There is no intention to commercialise the findings at this stage nor to&#xD;
        use the data for CE-marking.&#xD;
  &#xD;
        Participants will be patients with clinically complete spinal cord injury who already have a&#xD;
        commercially available implanted Finetech Brindley bladder stimulator with electrodes on the&#xD;
        sacral nerves or roots, controlled by an external transmitter whose frequency can be adjusted&#xD;
        by the investigator. This study will explore modified stimulation parameters and will deliver&#xD;
        the stimulation pattern with a modified/experimental external stimulation control unit. The&#xD;
        motivation for exploring these parameters is to see if clinical efficacy might be improved&#xD;
        for future systems.&#xD;
  &#xD;
        Primary outcome: Measurement of the effects of high and low frequency stimulation of the&#xD;
        sacral efferent nerves on Bladder Pressure, rectal pressure, Detrusor pressure, Sphincter&#xD;
        pressure, volume voided, post-void residual volume, voiding flow rate&#xD;
  &#xD;
        Secondary measures: Effects of low frequency stimulation on bladder pressure, bladder&#xD;
        capacity and reflex incontinence&#xD;
  &#xD;
        The exploration of these novel stimulation parameters will require modification of the&#xD;
        existing CE-marked system. The modifications will be limited to the external stimulation&#xD;
        control unit, and will not compromise either the implantable system or its capability to&#xD;
        continue normal operation with the existing CE-marked external control unit. The modified&#xD;
        external stimulation control unit will be referred to as the &quot;research stimulation&#xD;
        controller.&quot; The use environment for the research stimulation controller will be a controlled&#xD;
        hospital/laboratory setting, under clinical supervision. Outside of the clinic, the CE-marked&#xD;
        system will be used to ensure normal therapy is provided to the subject. Access to the&#xD;
        research stimulation controller will be controlled by the PI to prevent inadvertent misuse.&#xD;
  &#xD;
        The development of the research stimulation controller will follow accepted good design&#xD;
        practices. More specifically, the team will use a scaled version of 13845-compliant processes&#xD;
        to 1) assess user needs 2) generate a risk analysis and plan 3) develop system requirements&#xD;
        from design inputs 4) document and summarize design outputs 5) perform device verification&#xD;
        tests and 6) perform user validation tests. These files will be maintained in a controlled&#xD;
        document system.&#xD;
  &#xD;
        The modified controller is similar to the CE marked device but will allow the investigators&#xD;
        to explore a wider range of electrical stimulation parameters such as different waveforms and&#xD;
        higher frequencies. Our intention is to use up to 600 Hz frequencies, compared to the&#xD;
        existing frequencies in this device of up to 53 Hz. These changes are modest and are well&#xD;
        within the energy delivery provided by existing commercial neuromodulation systems such as&#xD;
        spinal cord stimulation (typical parameters for spinal cord stimulation include the Nevro®&#xD;
        system that delivers up to 10kHz). Patients both with and without posterior sacral rhizotomy&#xD;
        will also be included. No further surgery is required. Measurements of bladder function will&#xD;
        be made in the urodynamic laboratory.&#xD;
  &#xD;
        The study is prospective and unblinded. Each participant will serve as their own control;&#xD;
        outcome measures will be compared with different frequencies of electrical stimuli and with&#xD;
        no electrical stimuli.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 18, 2021</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Bladder Pressure</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics testing - High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rectal Pressure</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics- High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Detrusor Pressure</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics- High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sphincter Pressure</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics1- High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Volume voided</measure>
      <time_frame>2-3 hours</time_frame>
      <description>urodynamics- High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Post-void residual volume</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics- High frequency SARS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voiding Flow Rate</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics- High frequency SARS</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bladder pressure</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics - Low frequency SARS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bladder Capacity</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics - Low frequency SARS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reflex incontinence</measure>
      <time_frame>2-3 hours</time_frame>
      <description>Urodynamics - Low frequency SARS</description>
    </secondary_outcome>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Bladder Dysfunction</condition>
    <condition>Spinal Cord Injuries</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sacral Anterior Root Stimulation (SARS)</intervention_name>
      <description>Comparison of High frequency versus low frequency stimulation</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with clinically complete spinal cord injury who have undergone implantation of a&#xD;
          Finetech Brindley Bladder Controller, with or without sacral posterior rhizotomy. John&#xD;
          Radcliffe Hospital (Oxford), Royal National Orthopaedic Hospital (Stanmore) and Walton&#xD;
          Centre (Liverpool) will be both patient identification centres and research sites for this&#xD;
          study. Stoke Mandeville Hospital will be an additional patient identification centre, but&#xD;
          studies on patients identified there will be conducted at Oxford as patients are generally&#xD;
          under joint care between Stoke Mandeville Hospital and Oxford.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with clinically complete spinal cord injury who have undergone implantation&#xD;
               of a Finetech Brindley Bladder controller, with or without sacral posterior rhizotomy.&#xD;
  &#xD;
            -  Male or female, aged 18 years or over.&#xD;
  &#xD;
            -  Patients willing and able to give informed consent to involvement in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  External urethral sphincterotomy&#xD;
  &#xD;
            -  Patients are taking part in any studies on drugs or devices that alter bladder or&#xD;
               autonomic function&#xD;
  &#xD;
            -  Any other significant comorbidity or illness that would preclude their participation&#xD;
               or increase the risk to them of participating in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Oxford</name>
        <address>
          <city>Oxford</city>
          <state>Oxon</state>
          <zip>OX3 9DU</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alexander L Green, PhD</last_name>
        <phone>+44(0)1865234762</phone>
        <email>alex.green@nds.ox.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Alex Fung, MB BS</last_name>
        <email>alex.fung1@nhs.net</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 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>Spinal Cord Injuries</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968352
  org study id: IRAS 260021
  nct id: NCT05968352
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to develop improved methods of restoring function to the neurogenic
        bladder, using electrical stimulation without cutting nerves in patients with spinal cord
        injury.
  
        The investigators will test 5-10 subjects with existing sacral anterior root stimulation
        (SARS) devices and look at the effects of high frequency (up to 600Hz) compared to the usual
        low frequency stimulation on bladder function. The investigators are particularly interested
        in whether it is possible to reproduce a 'functional' dorzal rhizotomy using high frequency
        stimulation of the S2 efferent nerves
  This is a proof of concept study of the effects on the urinary bladder and sphincter of high
        frequency stimuli applied to sacral efferent nerves. The effects on the bladder of low
        frequency stimuli applied to sacral afferent nerves will also be studied. It is also part of
        an academic collaboration between Oxford and Stanford University. The results will not be
        sold to Stanford but will be shared to enhance the development of therapies for patients with
        spinal cord injury. There is no intention to commercialise the findings at this stage nor to
        use the data for CE-marking.
  
        Participants will be patients with clinically complete spinal cord injury who already have a
        commercially available implanted Finetech Brindley bladder stimulator with electrodes on the
        sacral nerves or roots, controlled by an external transmitter whose frequency can be adjusted
        by the investigator. This study will explore modified stimulation parameters and will deliver
        the stimulation pattern with a modified/experimental external stimulation control unit. The
        motivation for exploring these parameters is to see if clinical efficacy might be improved
        for future systems.
  
        Primary outcome: Measurement of the effects of high and low frequency stimulation of the
        sacral efferent nerves on Bladder Pressure, rectal pressure, Detrusor pressure, Sphincter
        pressure, volume voided, post-void residual volume, voiding flow rate
  
        Secondary measures: Effects of low frequency stimulation on bladder pressure, bladder
        capacity and reflex incontinence
  
        The exploration of these novel stimulation parameters will require modification of the
        existing CE-marked system. The modifications will be limited to the external stimulation
        control unit, and will not compromise either the implantable system or its capability to
        continue normal operation with the existing CE-marked external control unit. The modified
        external stimulation control unit will be referred to as the "research stimulation
        controller." The use environment for the research stimulation controller will be a controlled
        hospital/laboratory setting, under clinical supervision. Outside of the clinic, the CE-marked
        system will be used to ensure normal therapy is provided to the subject. Access to the
        research stimulation controller will be controlled by the PI to prevent inadvertent misuse.
  
        The development of the research stimulation controller will follow accepted good design
        practices. More specifically, the team will use a scaled version of 13845-compliant processes
        to 1) assess user needs 2) generate a risk analysis and plan 3) develop system requirements
        from design inputs 4) document and summarize design outputs 5) perform device verification
        tests and 6) perform user validation tests. These files will be maintained in a controlled
        document system.
  
        The modified controller is similar to the CE marked device but will allow the investigators
        to explore a wider range of electrical stimulation parameters such as different waveforms and
        higher frequencies. Our intention is to use up to 600 Hz frequencies, compared to the
        existing frequencies in this device of up to 53 Hz. These changes are modest and are well
        within the energy delivery provided by existing commercial neuromodulation systems such as
        spinal cord stimulation (typical parameters for spinal cord stimulation include the Nevro®
        system that delivers up to 10kHz). Patients both with and without posterior sacral rhizotomy
        will also be included. No further surgery is required. Measurements of bladder function will
        be made in the urodynamic laboratory.
  
        The study is prospective and unblinded. Each participant will serve as their own control;
        outcome measures will be compared with different frequencies of electrical stimuli and with
        no electrical stimuli.
  observational model: Case-Only
  time perspective: Prospective
  measure: Bladder Pressure
  time frame: 2-3 hours
  description: Urodynamics testing - High frequency SARS
  measure: Rectal Pressure
  time frame: 2-3 hours
  description: Urodynamics- High frequency SARS
  measure: Detrusor Pressure
  time frame: 2-3 hours
  description: Urodynamics- High frequency SARS
  measure: Sphincter Pressure
  time frame: 2-3 hours
  description: Urodynamics1- High frequency SARS
  measure: Volume voided
  time frame: 2-3 hours
  description: urodynamics- High frequency SARS
  measure: Post-void residual volume
  time frame: 2-3 hours
  description: Urodynamics- High frequency SARS
  measure: Voiding Flow Rate
  time frame: 2-3 hours
  description: Urodynamics- High frequency SARS
  measure: Bladder pressure
  time frame: 2-3 hours
  description: Urodynamics - Low frequency SARS
  measure: Bladder Capacity
  time frame: 2-3 hours
  description: Urodynamics - Low frequency SARS
  measure: Reflex incontinence
  time frame: 2-3 hours
  description: Urodynamics - Low frequency SARS
  intervention type: Device
  intervention name: Sacral Anterior Root Stimulation (SARS)
  description: Comparison of High frequency versus low frequency stimulation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Spinal Cord Injuries
  mesh term: Wounds and Injuries
  sharing ipd: No