Last updated: July 21, 2021
Sponsor: I.M. Sechenov First Moscow State Medical University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Infertility
Erectile Dysfunction
Male Hormonal Deficiencies/abnormalities
Treatment
N/AClinical Study ID
NCT04506658
07-20 from 15.04.2020
Ages 18-79 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients aged 18 to 79 years;
- The diagnosis is confirmed by assessing the functional criteria of arterial factors ofpanel 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'sdisease);
- The presence of diseases predisposing to the development of priapism (sickle cellanemia, 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 theeffectiveness of therapy; history of alcoholism and drug addiction;
- Active tuberculosis, chronic somatic diseases in the acute stage; 15. Condition aftercoronary artery bypass grafting (CABG); 16. Patient's involvement in another clinical trialin the last 3 months;
Exclusion
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 severityof 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.
Study Design
Total Participants: 60
Study Start date:
June 01, 2020
Estimated Completion Date:
December 31, 2021
Study Description
Connect with a study center
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, 119991
Russian FederationActive - Recruiting
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