<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/NCT03239951</url>
  </required_header>
  <id_info>
    <org_study_id>MT-04</org_study_id>
    <nct_id>NCT03239951</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy, Safety and Tolerability of (iTind)</brief_title>
  <official_title>One-arm, Controlled, Multi-Center Prospective Study to Assess the Efficacy, Safety and Tolerability of Medi-Tate Temporary Implantable Nitinol Device (iTind) in Subjects With Acute Urinary Retention Secondary to (BPO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medi-Tate Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medi-Tate Ltd.</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>
      Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.&#xD;
&#xD;
      A total of 50 eligible subjects will be recruited into the study to receive treatment with&#xD;
      iTind system.&#xD;
&#xD;
      Study duration will be 12 months post implantation, with follow-up extension of up to 3&#xD;
      years. Extension of follow up period will not require an additional ICF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spontaneous acute urinary retention (AUR) is one of the most significant complications of&#xD;
      long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate&#xD;
      indication for surgery. Between 25% and 30% of men who underwent transurethral prostatectomy&#xD;
      (TURP) had AUR as their main indication in older series and today most subjects failing to&#xD;
      void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an&#xD;
      important and feared event from the viewpoint of the subject. The subject originally has&#xD;
      inability to urinate, with increasing pain, and eventually a visit to the emergency room,&#xD;
      catheterization, follow-up visits to the physicians, an attempt at catheter removal, and&#xD;
      eventual recovery or surgery, which is both painful and time consuming.&#xD;
&#xD;
      After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC)&#xD;
      and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a&#xD;
      recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that&#xD;
      are refractory to medical management will be considered for surgery.&#xD;
&#xD;
      In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of&#xD;
      the first episode and 76% to 83% in men with diagnosed BPH.&#xD;
&#xD;
      (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten&#xD;
      percent of men in their seventies and 30% in their eighties will have AUR within the next&#xD;
      five years.&#xD;
&#xD;
      Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with&#xD;
      AUR.&#xD;
&#xD;
      In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for&#xD;
      men aged 40-49 years and 10% at 70-79 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the COVID-19 outbreak and the overall low recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">February 27, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 20, 2020</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>Ability to void without catheter</measure>
    <time_frame>2 weeks</time_frame>
    <description>TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>BPH</condition>
  <arm_group>
    <arm_group_label>Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Temporary implant (iTind)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iTind</intervention_name>
    <description>temporary implant</description>
    <arm_group_label>Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male with AUR secondary to BPO&#xD;
&#xD;
          -  Age ≥40 years&#xD;
&#xD;
          -  Acute urinary retention with at least one failed trial without catheter (TWOC) while&#xD;
             on alpha blocker&#xD;
&#xD;
          -  Ability to sign an informed consent form&#xD;
&#xD;
          -  Prostate volume &lt;80 ml&#xD;
&#xD;
          -  Life expectancy &gt;1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suspected malignant disease of the lower urinary tract including prostate or bladder&#xD;
             cancer&#xD;
&#xD;
          -  Chronic retention of urine with history of either retention volume greater than one&#xD;
             liter or upper tract obstruction&#xD;
&#xD;
          -  Known neurogenic bladder&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  Suspected urethral strictures, bladder neck contracture, Urinary bladder stones&#xD;
&#xD;
          -  An obstructive or protruding median lobe of the prostate&#xD;
&#xD;
          -  An active symptomatic urinary tract infection&#xD;
&#xD;
          -  Enrolled in another treatment trial for any disease&#xD;
&#xD;
          -  Previous pelvic irradiation or radical pelvic surgery&#xD;
&#xD;
          -  Any previous prostate surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gordon Muir, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King's College Hospital NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Firmly Park Hospital</name>
      <address>
        <city>Frimley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's college</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03239951
org study id: MT-04
nct id: NCT03239951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subjects with AUR secondary to BPO that comply with Inclusion/Exclusion Criteria.

      A total of 50 eligible subjects will be recruited into the study to receive treatment with
      iTind system.

      Study duration will be 12 months post implantation, with follow-up extension of up to 3
      years. Extension of follow up period will not require an additional ICF.
Spontaneous acute urinary retention (AUR) is one of the most significant complications of
      long-term benign prostatic hyperplasia (BPH). In the past it has represented an immediate
      indication for surgery. Between 25% and 30% of men who underwent transurethral prostatectomy
      (TURP) had AUR as their main indication in older series and today most subjects failing to
      void after attempted catheter removal still undergo surgery. For this reason alone, AUR is an
      important and feared event from the viewpoint of the subject. The subject originally has
      inability to urinate, with increasing pain, and eventually a visit to the emergency room,
      catheterization, follow-up visits to the physicians, an attempt at catheter removal, and
      eventual recovery or surgery, which is both painful and time consuming.

      After the acute period most men with AUR will be offered a 'trial without catheter' (TWOC)
      and about half will resume spontaneous voiding. Most men who fail a TWOC, experience a
      recurrent episode of AUR, or have moderate or severe lower urinary tract symptoms (LUTS) that
      are refractory to medical management will be considered for surgery.

      In the older literature, the risk of recurrent AUR was cited as 56% to 64% within 1 week of
      the first episode and 76% to 83% in men with diagnosed BPH.

      (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1476058/). Additional researches show that ten
      percent of men in their seventies and 30% in their eighties will have AUR within the next
      five years.

      Benign prostatic hyperplasia is the cause for the AUR in at least 65% of men presenting with
      AUR.

      In the below study of the natural history of BPH, the risk of AUR was 1.6% at five years for
      men aged 40-49 years and 10% at 70-79 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ability to void without catheter
time frame: 2 weeks
description: TWOC Success Rate, defined as the proportion (%) of subjects successfully undergoing the TWOC assessment at the later of visit 3 or visit 4.
arm group label: Device
arm group type: Experimental
description: Temporary implant (iTind)
intervention type: Device
intervention name: iTind
description: temporary implant
arm group label: Device
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: No
last name: Gordon Muir, MD
role: Principal Investigator
affiliation: King's College Hospital NHS Trust
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor