<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/NCT04473469</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00180124</org_study_id>
    <secondary_id>OT2OD028191</secondary_id>
    <nct_id>NCT04473469</nct_id>
  </id_info>
  <brief_title>Previously Implanted Pudendal Nerve Stimulation</brief_title>
  <official_title>Previously Implanted Pudendal Nerve Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</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>
      This study seeks to examine the response of the bladder to different pudendal nerve&#xD;
      stimulation frequencies, by studying patients who have been previously-implanted with&#xD;
      pudendal nerve neurostimulators.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical&#xD;
      stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain.&#xD;
      Researchers do not fully understand how the nerve helps with these functions or how the&#xD;
      anatomy is different between people. Successful stimulation of the pudendal nerve may help&#xD;
      improve medical care for future patients with bladder problems, pelvic pain, bowel problems,&#xD;
      and/or sexual problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 19, 2021</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evoked bladder contractions of at least 20 centimeters of water (cmH2O)</measure>
    <time_frame>Visit 1, approximately 1 week after consent</time_frame>
    <description>At least 50% of participants</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Urinary Retention</condition>
  <condition>Underactive Bladder</condition>
  <arm_group>
    <arm_group_label>Cystometrogram</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic Interstim II Model 3058 Neurostimulator</intervention_name>
    <description>Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).</description>
    <arm_group_label>Cystometrogram</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previously received an implanted neurostimulator at the pudendal nerve&#xD;
&#xD;
          -  Adult (18 or older), capable of providing own informed consent and communicating&#xD;
             clearly with the research team&#xD;
&#xD;
          -  Capable of speaking, reading, and understanding English, as all study questionnaires&#xD;
             are standardized assessments only available in English.&#xD;
&#xD;
          -  Capable of attending the experimental session&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during study. If a woman of child- bearing&#xD;
             potential wishes to participate in this study, they will be pre-screened with a test&#xD;
             to detect pregnancy&#xD;
&#xD;
          -  Currently has a urinary tract infection (UTI)&#xD;
&#xD;
          -  Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic&#xD;
             for COVID-19&#xD;
&#xD;
          -  Unwilling to allow de-identified data to be stored for future use or shared with other&#xD;
             researchers&#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>Tim Bruns, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Priyanka Gupta, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mackenzie Moore, MPH</last_name>
    <phone>734-647-8568</phone>
    <email>mooremac@med.umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mackenzie Moore, MPH</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT04236596</url>
    <description>Related Pudendal Nerve Stimulation Study</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 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>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Timothy Bruns</investigator_full_name>
    <investigator_title>Associate Professor of Biomedical Engineering, Medical School</investigator_title>
  </responsible_party>
  <keyword>Pudendal nerve mapping</keyword>
  <keyword>Nerve stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
    <mesh_term>Urinary Bladder, Underactive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All de-identified IPD collected during the trial will be available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Will be available twelve months following publication of study findings, or earlier.</ipd_time_frame>
    <ipd_access_criteria>Anyone who wishes to access the data.</ipd_access_criteria>
    <ipd_url>https://sparc.science/data?type=dataset</ipd_url>
  </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/NCT04473469
org study id: HUM00180124
secondary id: OT2OD028191
nct id: NCT04473469
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study seeks to examine the response of the bladder to different pudendal nerve
      stimulation frequencies, by studying patients who have been previously-implanted with
      pudendal nerve neurostimulators.
The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical
      stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain.
      Researchers do not fully understand how the nerve helps with these functions or how the
      anatomy is different between people. Successful stimulation of the pudendal nerve may help
      improve medical care for future patients with bladder problems, pelvic pain, bowel problems,
      and/or sexual problems.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Evoked bladder contractions of at least 20 centimeters of water (cmH2O)
time frame: Visit 1, approximately 1 week after consent
description: At least 50% of participants
arm group label: Cystometrogram
arm group type: Experimental
description: The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.
intervention type: Device
intervention name: Medtronic Interstim II Model 3058 Neurostimulator
description: Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
arm group label: Cystometrogram
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tim Bruns, Ph.D.
role: Principal Investigator
affiliation: University of Michigan
last name: Priyanka Gupta, M.D.
role: Principal Investigator
affiliation: University of Michigan
last name: Mackenzie Moore, MPH
phone: 734-647-8568
email: mooremac@med.umich.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://clinicaltrials.gov/ct2/show/NCT04236596
description: Related Pudendal Nerve Stimulation Study
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Timothy Bruns
investigator title: Associate Professor of Biomedical Engineering, Medical School
mesh term: Urinary Retention
mesh term: Urinary Bladder, Underactive
sharing ipd: Yes
ipd description: All de-identified IPD collected during the trial will be available.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Will be available twelve months following publication of study findings, or earlier.
ipd access criteria: Anyone who wishes to access the data.
ipd url: https://sparc.science/data?type=dataset