<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/NCT04506658</url>
  </required_header>
  <id_info>
    <org_study_id>07-20 from 15.04.2020</org_study_id>
    <nct_id>NCT04506658</nct_id>
  </id_info>
  <brief_title>Efficiency and Safety of High-frequency Radio Wave Electrotherapy With a Radio Frequency of 448 kHz in the Treatment of Patients With Organic Erectile Dysfunction.</brief_title>
  <official_title>Efficiency and Safety of High-frequency Radio Wave Electrotherapy With a Radio Frequency of 448 kHz in the Treatment of Patients With Organic Erectile Dysfunction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>I.M. Sechenov First Moscow State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>I.M. Sechenov First Moscow State Medical University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of&#xD;
      448 kHz in the treatment of patients with organic erectile dysfunction. Sham comparator,&#xD;
      parallel study including both the main and control group to demonstrate the efficiency of the&#xD;
      device to treat erectile dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this study are:&#xD;
&#xD;
        -  To evaluate the effectiveness of the course treatment with the apparatus for continuous&#xD;
           capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in&#xD;
           patients with organic erectile dysfunction.&#xD;
&#xD;
        -  Assess the safety and tolerability of continuous capacitive resistive monopolar&#xD;
           electrotherapy with a radio frequency of 448 kHz in patients with organic erectile&#xD;
           dysfunction.&#xD;
&#xD;
        -  To evaluate the duration of the effect of continuous capacitive resistive monopolar&#xD;
           electrotherapy with a radio frequency of 448 kHz.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A statistically significant increase in the number of points IIEF-5</measure>
    <time_frame>Through study completion, an average of 3 months after first procedure</time_frame>
    <description>IIEF-5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>A statistically significant increase in penile blood flow.</measure>
    <time_frame>Through study completion, an average of 3 months after first procedure</time_frame>
    <description>According to Doppler</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Statistically significant increase in SEP scores (Sexual Encounter Profile)</measure>
    <time_frame>Through study completion, an average of 3 months after first procedure</time_frame>
    <description>Schramek grading system score for assessing penile rigidity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.</intervention_name>
    <description>Patient in lithotomy position (supine) with return plate at lumbar level.&#xD;
Start with high power (within the allowed range) to get a faster hyperthermia and slowly decrease this percentage as the current builds up in the patient's body.&#xD;
Patients are undergoing high-frequency radio wave electrotherapy 2 times a week (12 procedures at all).</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.</intervention_name>
    <description>Doctor uses sham sensor to reduce efficiency to zero.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 18 to 79 years;&#xD;
&#xD;
          2. The diagnosis is confirmed by assessing the functional criteria of arterial factors of&#xD;
             panel hemodynamics (dopplerography);&#xD;
&#xD;
          3. The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire&#xD;
&#xD;
          4. Patients with organic erectile dysfunction lasting at least 6 months.&#xD;
&#xD;
          5. Patients with IIEF from 6 to 22 points.&#xD;
&#xD;
          6. Patients with a permanent sexual partner for more than 3 months;&#xD;
&#xD;
          7. Sexually Active Patients.&#xD;
&#xD;
        Non-inclusion criteria:&#xD;
&#xD;
          1. The use of other treatments for erectile dysfunction&#xD;
&#xD;
          2. Age under 18 and over 79 years old;&#xD;
&#xD;
          3. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's&#xD;
             disease);&#xD;
&#xD;
          4. The presence of diseases predisposing to the development of priapism (sickle cell&#xD;
             anemia, multiple myeloma, leukemia, thrombocytopenia);&#xD;
&#xD;
          5. Running coagulation disorders;&#xD;
&#xD;
          6. The presence of tumors in the area of electrotherapy;&#xD;
&#xD;
          7. The presence of aneurysms in the propagation of radio frequency waves;&#xD;
&#xD;
          8. Angina pectoris;&#xD;
&#xD;
          9. Myocardial infarction, stroke, life-threatening arrhythmias;&#xD;
&#xD;
         10. Thrombosis, thromboembolic disease;&#xD;
&#xD;
         11. Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤&#xD;
             90/50 mm Hg.);&#xD;
&#xD;
         12. The patient has a mental illness that does not allow an assessment of the&#xD;
             effectiveness of therapy; history of alcoholism and drug addiction;&#xD;
&#xD;
        14. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition after&#xD;
        coronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trial&#xD;
        in the last 3 months;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Serious unwanted phenomenons associated with exposure to the apparatus.&#xD;
&#xD;
          2. Incorrect inclusion in the study.&#xD;
&#xD;
          3. A marked deterioration in the patient's condition due to an increase in the severity&#xD;
             of the disease or the attachment of another disease.&#xD;
&#xD;
          4. The patient's appearance of non-inclusion criteria during the study.&#xD;
&#xD;
          5. Serious deviation from the protocol.&#xD;
&#xD;
          6. The desire of the patient or his legal representative.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitry Korolev, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sechenov University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dmitry Enikeev, M.D., Ph.D.</last_name>
    <phone>89267677873</phone>
    <email>dvenikeev@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dmitry Korolev, M.D.</last_name>
    <phone>89267677873</phone>
    <email>korolevdmitryo@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute for Urology and Reproductive Health, Sechenov University.</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dmitry Enikeev, M.D., Ph.D</last_name>
      <phone>+79267677873</phone>
      <email>enikeev-dv@1msmu.ru</email>
    </contact>
    <contact_backup>
      <last_name>Dmitry Korolev, MD</last_name>
      <phone>+79267677873</phone>
      <email>marktaratkin@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://www.sechenov.ru</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>http://www.urologypro.ru</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>I.M. Sechenov First Moscow State Medical University</investigator_affiliation>
    <investigator_full_name>Dmitry Enikeev, MD, PhD</investigator_full_name>
    <investigator_title>Director for Research</investigator_title>
  </responsible_party>
  <keyword>high-frequency radio wave electrotherapy</keyword>
  <keyword>radio frequency</keyword>
  <keyword>448 kHz</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Erectile Dysfunction</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/NCT04506658
org study id: 07-20 from 15.04.2020
nct id: NCT04506658
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Efficiency and safety of high-frequency radio wave electrotherapy with a radio frequency of
      448 kHz in the treatment of patients with organic erectile dysfunction. Sham comparator,
      parallel study including both the main and control group to demonstrate the efficiency of the
      device to treat erectile dysfunction.
The objectives of this study are:

        -  To evaluate the effectiveness of the course treatment with the apparatus for continuous
           capacitive resistive monopolar electrotherapy with a radio frequency of 448 kHz in
           patients with organic erectile dysfunction.

        -  Assess the safety and tolerability of continuous capacitive resistive monopolar
           electrotherapy with a radio frequency of 448 kHz in patients with organic erectile
           dysfunction.

        -  To evaluate the duration of the effect of continuous capacitive resistive monopolar
           electrotherapy with a radio frequency of 448 kHz.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: A statistically significant increase in the number of points IIEF-5
time frame: Through study completion, an average of 3 months after first procedure
description: IIEF-5
measure: A statistically significant increase in penile blood flow.
time frame: Through study completion, an average of 3 months after first procedure
description: According to Doppler
measure: Statistically significant increase in SEP scores (Sexual Encounter Profile)
time frame: Through study completion, an average of 3 months after first procedure
description: Schramek grading system score for assessing penile rigidity
arm group label: Intervention group
arm group type: Experimental
arm group label: Control group
arm group type: Sham Comparator
intervention type: Device
intervention name: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
description: Patient in lithotomy position (supine) with return plate at lumbar level.
Start with high power (within the allowed range) to get a faster hyperthermia and slowly decrease this percentage as the current builds up in the patient's body.
Patients are undergoing high-frequency radio wave electrotherapy 2 times a week (12 procedures at all).
arm group label: Intervention group
intervention type: Device
intervention name: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
description: Doctor uses sham sensor to reduce efficiency to zero.
arm group label: Control group
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Dmitry Korolev, M.D.
role: Principal Investigator
affiliation: Sechenov University
last name: Dmitry Enikeev, M.D., Ph.D.
phone: 89267677873
email: dvenikeev@gmail.com
last name: Dmitry Korolev, M.D.
phone: 89267677873
email: korolevdmitryo@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
url: http://www.sechenov.ru
description: Related Info
url: http://www.urologypro.ru
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: I.M. Sechenov First Moscow State Medical University
investigator full name: Dmitry Enikeev, MD, PhD
investigator title: Director for Research
mesh term: Erectile Dysfunction
sharing ipd: No