<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/NCT03006536</url>
  </required_header>
  <id_info>
    <org_study_id>SJ-590</org_study_id>
    <nct_id>NCT03006536</nct_id>
  </id_info>
  <brief_title>Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial</brief_title>
  <official_title>Low-Intensity Extracorporeal Shock Wave Treatment for Erectile Dysfunction: A Randomized, Controlled, Double Blind Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zealand University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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 proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function&#xD;
      and triggers angiogenesis through induction of local growth factors and endothelial nitric&#xD;
      oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies&#xD;
      investigating the clinical effects have been encouraging. Meanwhile, randomized trials have&#xD;
      shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed&#xD;
      statistically greater improvements in the Erectile Function Domain of the International Index&#xD;
      of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment&#xD;
      (p=0.032).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">March 13, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 13, 2022</primary_completion_date>
  <phase>N/A</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>International Index of Erectile Function (IIEF)</measure>
    <time_frame>1 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Li-ESWT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Li-ESWT</intervention_name>
    <description>Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions</description>
    <arm_group_label>Li-ESWT</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-70 years&#xD;
&#xD;
          -  A history of erectile dysfunction for &gt;6 months&#xD;
&#xD;
          -  IIEF-ED score &lt; 25&#xD;
&#xD;
          -  In a stable heterosexual relationship for at least 6 months&#xD;
&#xD;
          -  Willingness to attempt sexual intercourse at least twice per week during the study and&#xD;
             follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychogenic ED as assessed by a standardized interview (attachment 2)&#xD;
&#xD;
          -  Known psychiatric illness&#xD;
&#xD;
          -  Neurological disease (including Parkinson's disease, Multiple sclerosis, spinal cord&#xD;
             injury, and a history of stroke)&#xD;
&#xD;
          -  Traumatic nerve injury&#xD;
&#xD;
          -  Previous pelvic surgery or radiation&#xD;
&#xD;
          -  Heart disease in the form of unstable angina, NYHA class &gt;II heart failure,&#xD;
             uncontrolled arrhythmia, or significantly symptomatic and/or severe valvular disease&#xD;
&#xD;
          -  Endocrine disease including hypogonadism (total testosterone &lt;12 nmol/l)&#xD;
&#xD;
          -  Insulin dependent or uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Dependence on erectogenic aids other than PDE5-Inhibitors&#xD;
&#xD;
          -  Use of medications which have been shown to interfere with erections&#xD;
&#xD;
          -  Use of anticoagulant medications other than low dose aspirin&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  A diagnoses of Peyronie's disease and/or prior occurrence of priapism&#xD;
&#xD;
          -  Alcohol abuse (more than 21 containers of alcohol per week)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Roskilde</city>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nessn H. Azawi, M.D.</last_name>
      <phone>004526393034</phone>
      <email>nesa@regionsjaelland.dk</email>
    </contact>
    <investigator>
      <last_name>Nessn Azawi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>September 16, 2021</last_update_submitted>
  <last_update_submitted_qc>September 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Nessn Azawi</investigator_full_name>
    <investigator_title>Chief Urologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</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/NCT03006536
org study id: SJ-590
nct id: NCT03006536
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The proposed mechanism of action for LI-ESWT in ED is that it improves endothelial function
      and triggers angiogenesis through induction of local growth factors and endothelial nitric
      oxide synthase. The literature generally confirms that LI-ESWT is safe and cohort studies
      investigating the clinical effects have been encouraging. Meanwhile, randomized trials have
      shown contradictory results. Thus, a randomized trial in 67 PDE5-I responders showed
      statistically greater improvements in the Erectile Function Domain of the International Index
      of Erectile Function (IIEF) with active LI-ESWT treatment compared to a sham treatment
      (p=0.032).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: International Index of Erectile Function (IIEF)
time frame: 1 months
arm group label: Li-ESWT
arm group type: Experimental
description: Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
arm group label: Sham
arm group type: Sham Comparator
description: Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
intervention type: Device
intervention name: Li-ESWT
description: Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
arm group label: Li-ESWT
arm group label: Sham
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Nessn Azawi
investigator title: Chief Urologist
mesh term: Erectile Dysfunction