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.
NCT ID: NCT04506658
Last Updated: 2021-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2020-06-01
2021-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
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).
Control group
high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.
Doctor uses sham sensor to reduce efficiency to zero.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
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;
5. Serious deviation from the protocol.
6. The desire of the patient or his legal representative.
Exclusion Criteria
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.
18 Years
79 Years
MALE
No
Sponsors
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I.M. Sechenov First Moscow State Medical University
OTHER
Responsible Party
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Dmitry Enikeev, MD, PhD
Director for Research
Principal Investigators
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Dmitry Korolev, M.D.
Role: PRINCIPAL_INVESTIGATOR
Sechenov University
Locations
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Institute for Urology and Reproductive Health, Sechenov University.
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Related Info
Other Identifiers
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07-20 from 15.04.2020
Identifier Type: -
Identifier Source: org_study_id
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