Clinical trial NCT04506658: 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: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Keywords: high-frequency radio wave electrotherapy
radio frequency
448 kHz
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A statistically significant increase in the number of points IIEF-5
timeFrame: Through study completion, an average of 3 months after first procedure
Secondary outcomes:
measure: A statistically significant increase in penile blood flow.
timeFrame: Through study completion, an average of 3 months after first procedure
measure: Statistically significant increase in SEP scores (Sexual Encounter Profile)
timeFrame: Through study completion, an average of 3 months after first procedure
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute for Urology and Reproductive Health, Sechenov University.
Study officials:
affiliation: Sechenov University
name: Dmitry Korolev, M.D.
role: PRINCIPAL_INVESTIGATOR
References: