Status:
UNKNOWN
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.
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-79 years
Phase:
NA
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 incl...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04506658
Start Date
June 1 2020
End Date
December 31 2021
Last Update
July 22 2021
Active Locations (1)
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1
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia, 119991