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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.
The objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. | Device | 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Non-inclusion criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dmitry Enikeev, M.D., Ph.D. | Contact | 89267677873 | dvenikeev@gmail.com | |
| Dmitry Korolev, M.D. | Contact | 89267677873 | korolevdmitryo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dmitry Korolev, M.D. | Sechenov University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Urology and Reproductive Health, Sechenov University. | Recruiting | Moscow | 119991 | Russia |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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|
| high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. | Device | Doctor uses sham sensor to reduce efficiency to zero. |
|
Schramek grading system score for assessing penile rigidity
| Through study completion, an average of 3 months after first procedure |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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