Radiofrequency energy in the treatment of erectile dysfunction – a novel cohort pilot study on safety, applicability, and short-term efficacy

Abstract

Abstract Collagen is an essential component of the structures involved in the erectile mechanism and as such, impaired collagen may hinder it. Because Radiofrequency (RF) energy has been shown to renew and restore spatial structural arrangement of collagen fibers, treatment of ED with RF could lead to anatomical and physiological changes at the penile tissue level and could lead to improvement in the erectile mechanism. We conducted this study to assess the effect of RF treatment on erection quality. We evaluated the safety, applicability, and efficacy of a self-applied, handheld, low-intensity radiofrequency device (Vertica®) in men with moderate and mild-to-moderate organic ED. The treatment protocol consisted of 12 treatments (twice a week during the 1st month, and once a week during the 2nd month), each participant treated himself individually. Treatment outcomes were evaluated using the International Index of Erectile Function (IIEF-15), Erection Hardness Scale (EHS), Erectile Dysfunction Index of Treatment Satisfaction (EDITS), Benefit, Satisfaction & Willingness to continue (BSW), Quality of Erection Questionnaire (QEQ), Sexual Quality of Life (SQOL) questionnaires and specific questions addressing side-effects and ease of use. Twenty-eight out of 32 men (mean age 59.5.7 ± 9.8, range: 41-78y) completed a one-month follow-up after treatment. Mean IIEF-15 (43.7. ±7.8 vs 60.9 ± 10.8, p < 0.01), IIEF-Erection Function domain (IIEF-EF) (16.8 ± 3.1 vs. 24.4 ± 4.4, p < 0.001), and EHS scores (2.2 ± 0.8 vs. 3.2 ± 0.5, p = 0.01) were all significantly improved. Fifty percent of patients achieved normal EF parameters (IIEF-EF score ≥ 25). High mean scores were achieved in the EDITS (76.8 ± 20.3), BSW (4.83 ± 1.1), QEQ (73.4 ± 23.8), and SQOL (67 ± 29.4) questionnaires. No side effects were reported and participants rated the device as very comfortable, simple, and easy to operate.