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: * 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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).
Doctor uses sham sensor to reduce efficiency to zero.
Institute for Urology and Reproductive Health, Sechenov University.
Moscow, Russia
RECRUITINGA statistically significant increase in the number of points IIEF-5
IIEF-5
Time frame: Through study completion, an average of 3 months after first procedure
A statistically significant increase in penile blood flow.
According to Doppler
Time frame: Through study completion, an average of 3 months after first procedure
Statistically significant increase in SEP scores (Sexual Encounter Profile)
Schramek grading system score for assessing penile rigidity
Time frame: Through study completion, an average of 3 months after first procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.