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.

July 21, 2021 updated by: Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Recruiting
        • Institute for Urology and Reproductive Health, Sechenov University.
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Patients aged 18 to 79 years;
  2. The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel 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:

  1. The use of other treatments for erectile dysfunction
  2. Age under 18 and over 79 years old;
  3. Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease);
  4. The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia);
  5. Running coagulation disorders;
  6. The presence of tumors in the area of electrotherapy;
  7. The presence of aneurysms in the propagation of radio frequency waves;
  8. Angina pectoris;
  9. Myocardial infarction, stroke, life-threatening arrhythmias;
  10. Thrombosis, thromboembolic disease;
  11. Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.);
  12. The patient has a mental illness that does not allow an assessment of the effectiveness of therapy; history of alcoholism and drug addiction;

14. Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition after coronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trial in the last 3 months;

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 severity of 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.

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).

Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Doctor uses sham sensor to reduce efficiency to zero.
Sham Comparator: Control group
Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.

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).

Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Doctor uses sham sensor to reduce efficiency to zero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A statistically significant increase in the number of points IIEF-5
Time Frame: Through study completion, an average of 3 months after first procedure
IIEF-5
Through study completion, an average of 3 months after first procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A statistically significant increase in penile blood flow.
Time Frame: Through study completion, an average of 3 months after first procedure
According to Doppler
Through study completion, an average of 3 months after first procedure
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Time Frame: Through study completion, an average of 3 months after first procedure
Schramek grading system score for assessing penile rigidity
Through study completion, an average of 3 months after first procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.M. Sechenov First Moscow State Medical University

Investigators

  • Principal Investigator: Dmitry Korolev, M.D., Sechenov University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-20 from 15.04.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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