Trials / Unknown
UnknownNCT04506658
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.
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- I.M. Sechenov First Moscow State Medical University · Academic / Other
- Sex
- Male
- Age
- 18 Years – 79 Years
- Healthy volunteers
- Not accepted
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 including both the main and control group to demonstrate the efficiency of the device to treat erectile dysfunction.
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 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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). |
| DEVICE | high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures. | Doctor uses sham sensor to reduce efficiency to zero. |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2020-08-10
- Last updated
- 2021-07-22
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04506658. Inclusion in this directory is not an endorsement.