<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/NCT02249234</url>
  </required_header>
  <id_info>
    <org_study_id>CAN-BTX-RCT</org_study_id>
    <nct_id>NCT02249234</nct_id>
  </id_info>
  <brief_title>Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain</brief_title>
  <acronym>ROBOT</acronym>
  <official_title>Randomized Control Trial of the Use of Botox to Treat Chronic Scrotal Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with&#xD;
      scrotal pain that we found published.&#xD;
&#xD;
      We proposed a pilot study using Botox to block the nerves on a small group of men with&#xD;
      chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have&#xD;
      had temporary relief from a testicular cord block using local anaesthetic drug.&#xD;
&#xD;
      The encourage results of the pilot study has given us the background information to proceed&#xD;
      with a formal randomised control trial of Botox vs placebo.&#xD;
&#xD;
      We hypothesized that Botox injections to block the testicular nerve will be effective in&#xD;
      providing long term pain relief for men with scrotal pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in the visual analog scales for pain</measure>
    <time_frame>6 months after entering in trial</time_frame>
    <description>A measure of the change in the visual analog scales for pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in scrotal pain</measure>
    <time_frame>6 months after entering in trial</time_frame>
    <description>It will be assessed by the Chronic Epididymitis Symptom Index score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Scrotal Pain</condition>
  <arm_group>
    <arm_group_label>Botox</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Botox 200 units reconstituted in 10ml of normal saline for a one-time injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline 10ml of normal saline for a one-time injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Botox</intervention_name>
    <arm_group_label>Botox</arm_group_label>
    <other_name>OnabotulinumtoxinA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Have nociceptive scrotal pain,&#xD;
&#xD;
          -  Have no identifiable, reversible causes for the scrotal pain&#xD;
&#xD;
          -  Have failed standard medical therapy&#xD;
&#xD;
          -  Have responded temporarily to cord blocks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are interested in trying to conceive with their partners in the next 6 months,&#xD;
&#xD;
          -  Have any local infection near the site of the injections,&#xD;
&#xD;
          -  Have had an allergic reaction to Botox in the past,&#xD;
&#xD;
          -  Are unable to provide informed consent&#xD;
&#xD;
          -  Have a history of motor neuron disease or neurogenic bladder&#xD;
&#xD;
          -  Who have hemostatic disorder or who are taking aspirin, Coumadin (warfarin), Xarelto&#xD;
             (rivaroxaban) or other blood thinners&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Jarvi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mount Sinai Hospital, Canada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>March 8, 2019</last_update_submitted>
  <last_update_submitted_qc>March 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Scrotal pain</keyword>
  <keyword>Botox</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Botulinum Toxins, Type A</mesh_term>
  </intervention_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/NCT02249234
org study id: CAN-BTX-RCT
nct id: NCT02249234
lead sponsor: 
has dmc: No
There are no previous reports on the use of OnabotulinumtoxinA (Botox) to treat men with
      scrotal pain that we found published.

      We proposed a pilot study using Botox to block the nerves on a small group of men with
      chronic scrotal pain (CSP) who have failed the standard medical therapy. The men must have
      had temporary relief from a testicular cord block using local anaesthetic drug.

      The encourage results of the pilot study has given us the background information to proceed
      with a formal randomised control trial of Botox vs placebo.

      We hypothesized that Botox injections to block the testicular nerve will be effective in
      providing long term pain relief for men with scrotal pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Reduction in the visual analog scales for pain
time frame: 6 months after entering in trial
description: A measure of the change in the visual analog scales for pain.
measure: Reduction in scrotal pain
time frame: 6 months after entering in trial
description: It will be assessed by the Chronic Epididymitis Symptom Index score.
arm group label: Botox
arm group type: Experimental
description: Botox 200 units reconstituted in 10ml of normal saline for a one-time injection
arm group label: Saline
arm group type: Placebo Comparator
description: Saline 10ml of normal saline for a one-time injection
intervention type: Drug
intervention name: Botox
arm group label: Botox
other name: OnabotulinumtoxinA
intervention type: Drug
intervention name: Placebo
arm group label: Saline
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Keith Jarvi, MD
role: Principal Investigator
affiliation: Mount Sinai Hospital, Canada
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Botulinum Toxins, Type A