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 Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
* Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 79 years; The diagnosis is confirmed by assessing the functional criteria of arterial factors of panel hemodynamics (dopplerography); The diagnosis is confirmed by the assessment of the IIEF-5 questionnaire Patients with organic erectile dysfunction lasting at least 6 months. Patients with IIEF from 6 to 22 points. Patients with a permanent sexual partner for more than 3 months; Sexually Active Patients. Non-inclusion criteria: The use of other treatments for erectile dysfunction Age under 18 and over 79 years old; Anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie's disease); The presence of diseases predisposing to the development of priapism (sickle cell anemia, multiple myeloma, leukemia, thrombocytopenia); Running coagulation disorders; The presence of tumors in the area of electrotherapy; The presence of aneurysms in the propagation of radio frequency waves; Angina pectoris; Myocardial infarction, stroke, life-threatening arrhythmias; Thrombosis, thromboembolic disease; Arterial hypertension (blood pressure ≥ 170/90 mm Hg) or hypotension (blood pressure ≤ 90/50 mm Hg.); 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: Serious unwanted phenomenons associated with exposure to the apparatus. Incorrect inclusion in the study. A marked deterioration in the patient's condition due to an increase in the severity of the disease or the attachment of another disease. The patient's appearance of non-inclusion criteria during the study. Serious deviation from the protocol. The desire of the patient or his legal representative.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.<br>* 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).<br>|
| Sham Comparator: Control group<br> | Device: high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.<br>* Doctor uses sham sensor to reduce efficiency to zero.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A statistically significant increase in penile blood flow. | According to Doppler | Through study completion, an average of 3 months after first procedure | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high-frequency radio wave electrotherapy, radio frequency, 448 kHz