(030) Hand Held, Self-Applicable Radio Frequency Device for the Treatment of Erectile Dysfunction. A Pilot Study with 6 Months Follow-Up

Abstract

Abstract Introduction Collagen is an essential component of the structures involved in the erectile mechanism. Radiofrequency (RF) energy has been shown to renew and restore the spatial structural arrangement of collagen fibers and may improve erectile function of men suffering from erectile dysfunction (ED). Objective To assess the feasibility, safety, and efficacy of low-intensity radiofrequency (RF) therapy in men with ED. Methods Men with moderate & mild to moderate ED, with or without the use of PDE5-inhibitors were included. After instructions, each patient treated himself with the radiofrequency device (Vertica®), applying his selected individual RF intensity. Patients underwent, according to the protocol, 12 sessions of 30-minute treatments over 2 months. Patients were evaluated at baseline, 1, 3 and 6 months after treatment using validated questionnaires; International Index of Erectile Function (Full IIEF), IIEF-EF, and erection Hardness score (EHS), satisfaction (EDITS, BSW), and disease-specific quality and quality of life (QEQ, SQOL). In each session, patients filled safety and side-effect questions (pain, fever, burning, discomfort, urinary disorders). The Wilcoxon signed ranks test and the Marginal Homogeneity test were used for statistical processing. Results Twenty-seven out of 28 men treated, were available for 6 months follow-up, mean age 59.2±9.7. The mean ED duration was 41.2±29 months. Mean baseline IIEF-EF was 16.8±1 and improved significantly to 24.8±1.6, 24.3±1.8, and 24.2±2.08 at 1, 3 and 6 months respectively (p<0.001). The Minimal Clinical Important Difference (MCID) criteria were met by 25/28 (89%) at 1-month follow-up and 20/27(74%) at 6-month follow-up (p<0.001). A statistically and clinically significant improvement was demonstrated in the Full IIEF and EHS scores at baseline and during follow-up. No correlation was found between IIEF improvement and the age of the patients. Borderline significance (p=0.05) was found between the duration of ED and IIEF-EF improvement. No side effects were reported and participants rated the device as very comfortable and easy to operate. Conclusions The novel radiofrequency, home-use device for the treatment of ED shows promising results and the potential to improve erectile function. In this study, it was feasible and safe. Further high-quality randomized controlled trials are needed to determine the long-term efficacy of the treatment. Disclosure Yes, this is sponsored by industry/sponsor: Ohhmed, Israel. Clarification: No industry support in study design or execution. Any of the authors act as a consultant, employee or shareholder of an industry for: Ohhmed, Freya, Besins, Verility.