<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/NCT01666405</url>
  </required_header>
  <id_info>
    <org_study_id>UPC032012</org_study_id>
    <nct_id>NCT01666405</nct_id>
  </id_info>
  <brief_title>Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence</brief_title>
  <official_title>A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uroplasty, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uroplasty, Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of percutaneous tibial nerve&#xD;
      stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc.,&#xD;
      Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pilot Study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    business reasons&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 1</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>Effectiveness</measure>
    <time_frame>18 weeks</time_frame>
    <description>To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>18 weeks</time_frame>
    <description>To characterize adverse events experienced throughout the study</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Fecal Incontinence</condition>
  <arm_group>
    <arm_group_label>Urgent(R) PC Neuromodulation System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Urgent(R) PC Neuromodulation System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Urgent(R) PC Neuromodulation System</intervention_name>
    <description>The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).</description>
    <arm_group_label>Urgent(R) PC Neuromodulation System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient history of chronic FI of more than staining for at least 6 months; staining&#xD;
             defined as less than the size of a 25¢ piece (quarter)&#xD;
&#xD;
          -  Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber&#xD;
             modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback,&#xD;
             medical management, etc.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy or intention to become pregnant during the course of the study&#xD;
&#xD;
          -  Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain&#xD;
             stimulator, etc.)&#xD;
&#xD;
          -  Clinically significant neurological diseases or nerve damage impacting tibial nerve or&#xD;
             pelvic floor function&#xD;
&#xD;
          -  Prone to excessive bleeding or bleeding diathesis&#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>Kaiser Permanente Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSF Center for Colorectal Surgery</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Colon and Rectal Surgery Associates, Ltd.</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lindner Center for Research and Education at The Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorectal Surgical Asociates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Health and Services</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>October 28, 2015</last_update_submitted>
  <last_update_submitted_qc>October 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fecal Incontinence</keyword>
  <keyword>Bowel Incontinence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fecal Incontinence</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/NCT01666405
org study id: UPC032012
nct id: NCT01666405
lead sponsor: 
has dmc: No
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve
      stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc.,
      Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Pilot Study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness
time frame: 18 weeks
description: To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
measure: Safety
time frame: 18 weeks
description: To characterize adverse events experienced throughout the study
arm group label: Urgent(R) PC Neuromodulation System
arm group type: Experimental
description: Urgent(R) PC Neuromodulation System
intervention type: Device
intervention name: Urgent(R) PC Neuromodulation System
description: The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).
arm group label: Urgent(R) PC Neuromodulation System
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fecal Incontinence