<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/NCT02974673</url>
  </required_header>
  <id_info>
    <org_study_id>RC-P0052</org_study_id>
    <secondary_id>2016-A01441-50</secondary_id>
    <nct_id>NCT02974673</nct_id>
  </id_info>
  <brief_title>Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters</brief_title>
  <acronym>EDGE</acronym>
  <official_title>Ejaculation of Spinal Cord Patient: Pilot Study of Ejaculatory Dyssynergia by Electronic Microsensors of Sphincters</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</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 objective of this research is to study the sphincter activity during ejaculation in&#xD;
      patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this&#xD;
      purpose, using a catheter the protocol plans to measure the sphincter pressures during&#xD;
      ejaculation. Moreover, cardiovascular parameters will be measured continuously during the&#xD;
      ejaculatory test.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">February 15, 2017</start_date>
  <completion_date type="Actual">October 18, 2018</completion_date>
  <primary_completion_date type="Actual">October 18, 2018</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia</measure>
    <time_frame>at inclusion</time_frame>
    <description>The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of type of ejaculation by bladder catheterization</measure>
    <time_frame>at inclusion</time_frame>
    <description>The type of ejaculation ( antegrade, retrograde or mixed) will be determined by searching sperm in urines due to a bladder catheterization after ejaculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sphincter urethral pressure to asses type of ejaculatory dyssynergia</measure>
    <time_frame>at inclusion</time_frame>
    <description>The type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Spinal Injury Association score</measure>
    <time_frame>at inclusion</time_frame>
    <description>The neurological examination will be done by measuring the American Spinal Injury Association score, the international standard for evaluation of spinal cord injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of ejaculation after stimulation</measure>
    <time_frame>at inclusion</time_frame>
    <description>The stimulation parameters will be measured during vibro massage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amplitude of ejaculation after stimulation</measure>
    <time_frame>at inclusion</time_frame>
    <description>The stimulation parameters will be measured during vibro massage</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Spinal Cord Diseases</condition>
  <condition>Disorder of Ejaculation</condition>
  <arm_group>
    <arm_group_label>Ejaculatory test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Measures of sphincter pressures during ejaculation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ejaculatory test</intervention_name>
    <description>Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.</description>
    <arm_group_label>Ejaculatory test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients evaluated by ejaculatory test during their usual care&#xD;
&#xD;
          -  Men with spinal cord injury between 18 and 65 years old&#xD;
&#xD;
          -  Patients who have given their informed consent&#xD;
&#xD;
          -  Patients with social insurance affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors&#xD;
&#xD;
          -  Patients with justice protection&#xD;
&#xD;
          -  Patients over 65 years old&#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>Jean Gabriel Previnaire, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Calvé - Berck sur mer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean Marc Soler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center Bouffard Vercelli - Cerbère</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Calvé</name>
      <address>
        <city>Berck</city>
        <zip>62608</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Bouffard Vercelli</name>
      <address>
        <city>Cerbere</city>
        <zip>66290</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>November 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>Genito sexuals disorders</keyword>
  <keyword>Ejaculatory test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Ataxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02974673
org study id: RC-P0052
secondary id: 2016-A01441-50
nct id: NCT02974673
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this research is to study the sphincter activity during ejaculation in
      patients with spinal cord injury in order to detect an ejaculatory dyssynergia. For this
      purpose, using a catheter the protocol plans to measure the sphincter pressures during
      ejaculation. Moreover, cardiovascular parameters will be measured continuously during the
      ejaculatory test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sphincter urethral pressure measured by electronic microsensors to asses ejaculatory dyssynergia
time frame: at inclusion
description: The presence of an ejaculatory dyssynergia will be certify by analysis of sphincter urethral pressure curves registered by microsensors during ejaculation
measure: Determination of type of ejaculation by bladder catheterization
time frame: at inclusion
description: The type of ejaculation ( antegrade, retrograde or mixed) will be determined by searching sperm in urines due to a bladder catheterization after ejaculation
measure: Sphincter urethral pressure to asses type of ejaculatory dyssynergia
time frame: at inclusion
description: The type of ejaculatory dyssynergia will be determined by analysis of sphincter urethral pressures curves during ejaculation
measure: American Spinal Injury Association score
time frame: at inclusion
description: The neurological examination will be done by measuring the American Spinal Injury Association score, the international standard for evaluation of spinal cord injury
measure: Frequency of ejaculation after stimulation
time frame: at inclusion
description: The stimulation parameters will be measured during vibro massage
measure: Amplitude of ejaculation after stimulation
time frame: at inclusion
description: The stimulation parameters will be measured during vibro massage
arm group label: Ejaculatory test
arm group type: Experimental
description: Measures of sphincter pressures during ejaculation
intervention type: Procedure
intervention name: Ejaculatory test
description: Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.
arm group label: Ejaculatory test
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jean Gabriel Previnaire, MD
role: Study Director
affiliation: Centre Calvé - Berck sur mer
last name: Jean Marc Soler, MD
role: Principal Investigator
affiliation: Center Bouffard Vercelli - Cerbère
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Diseases
mesh term: Ataxia
sharing ipd: No