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.

Last updated: July 21, 2021
Sponsor: I.M. Sechenov First Moscow State Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Erectile Dysfunction

Male Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT04506658
07-20 from 15.04.2020
  • Ages 18-79
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 79 years;
  2. The diagnosis is confirmed by assessing the functional criteria of arterial factors ofpanel hemodynamics (dopplerography);
  3. The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire
  4. Patients with organic erectile dysfunction lasting at least 6 months.
  5. Patients with IIEF from 6 to 22 points.
  6. Patients with a permanent sexual partner for more than 3 months;
  7. Sexually Active Patients. Non-inclusion criteria:
  8. The use of other treatments for erectile dysfunction
  9. Age under 18 and over 79 years old;
  10. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie'sdisease);
  11. The presence of diseases predisposing to the development of priapism (sickle cellanemia, multiple myeloma, leukemia, thrombocytopenia);
  12. Running coagulation disorders;
  13. The presence of tumors in the area of electrotherapy;
  14. The presence of aneurysms in the propagation of radio frequency waves;
  15. Angina pectoris;
  16. Myocardial infarction, stroke, life-threatening arrhythmias;
  17. Thrombosis, thromboembolic disease;
  18. Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.);
  19. The patient has a mental illness that does not allow an assessment of theeffectiveness of therapy; history of alcoholism and drug addiction;
  20. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition aftercoronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trialin the last 3 months;

Exclusion

Exclusion Criteria:

  1. Serious unwanted phenomenons associated with exposure to the apparatus.
  2. Incorrect inclusion in the study.
  3. A marked deterioration in the patient's condition due to an increase in the severityof the disease or the attachment of another disease.
  4. The patient's appearance of non-inclusion criteria during the study.
  5. Serious deviation from the protocol.
  6. The desire of the patient or his legal representative.

Study Design

Total Participants: 60
Study Start date:
June 01, 2020
Estimated Completion Date:
December 31, 2021

Study Description

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.

Connect with a study center

  • Institute for Urology and Reproductive Health, Sechenov University.

    Moscow, 119991
    Russian Federation

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.