[Radio wave electrotherapy with a radiofrequency of 448 khz for the treatment of patients with organic erectile dysfunction: a prospective, randomized, blind, Sham-controlled, parallel-group study].

ABSTRACT

AIM: To evaluate the efficiency of radio wave electrotherapy (448 kHz) for the treatment of patients with organic erectile dysfunction (ED). MATERIALS AND METHODS: A prospective, randomized, blind, sham- controlled clinical trial was carried out. Inclusion criteria were as following 1) patients with 5 to 20 points on the IIEF-5 score; 2) patients with proven organic erectile dysfunction lasting at least 6 months; 3) patients with penile arterial insufficiency and/or venous insufficiency, confirmed by doppler study of penile vessels with pharmacological stimulation (peak systolic velocity (PSV) <25 cm/s, end-diastolic blood flow velocity (DPV) >5 cm/s, resistance index (IR) < 0.8). The participants were randomized into two groups (experimental and control) in a 11 ratio. The full treatment course lasted 9 weeks. Patients underwent an assessment of erectile function based on questionnaires (IIEF-5, SEP, Schramek), as well as Doppler ultrasound of the cavernous arteries before inclusion in the study as well as a after treatment. RESULTS: The study included 61 men (experimental group [n=31], control group [n=30]. There was a significant difference in the IIEF-5 scores after treatment between the experimental group and the control group (19.5+/-3.2 vs. 15.1+/-5.4, p=0.017, respectively). Significant differences were also noted in mean total score of the SEP questionnaire an increase to 3.6+/-1.0 in the treatment group compared to 2.4+/-1.1 in the control group (p=0.004). The results of the Schramek questionnaire also demonstrated a significant increase in the mean score in the experimental group compared to the control group 4.2+/-0.6 vs. 3.2+/-1.0 (p=0.011). The response time to the drug and the detumescence time also significantly differed between the two groups 11.9+/-4.0 min vs. 15.5+/-4.1 min, p=0.001 and 126.6+/-60.7 min vs. 66.2+/-40.9, p<0.001, respectively. Neither complications nor any adverse events were recorded during treatment or after its completion. CONCLUSIONS: Radio wave electrotherapy with a radiofrequency of 448 kHz can improve the IIEF-5, SEP and Schramek scores, as well as the indicators of ultrasound Doppler ultrasonography in patients with organic ED. To assess the feasibility of this method in patients with organic ED of different stages, further studies are needed.