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.

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04506658
• Other study ID #: 07-20 from 15.04.2020
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: Dmitry Enikeev, M.D., Ph.D.
• Phone: 89267677873
• Email: dvenikeev[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Institute for Urology and Reproductive Health, Sechenov University.	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A statistically significant increase in the number of points IIEF-5	IIEF-5	Through study completion, an average of 3 months after first procedure
Secondary	A statistically significant increase in penile blood flow.	According to Doppler	Through study completion, an average of 3 months after first procedure
Secondary	Statistically significant increase in SEP scores (Sexual Encounter Profile)	Schramek grading system score for assessing penile rigidity	Through study completion, an average of 3 months after first procedure

External Links

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