(289) SAFETY AND EFFICACY ASSESSMENT OF THE VERTICA® - A RADIO FREQUENCY DEVICE FOR THE TREATMENT OF ERECTILE DYSFUNCTION (ED)

Abstract Introduction The VERTICA® is a hand-held, home use device, designed to treat 'mild to moderate' and moderate erectile dysfunction (ED) using radiofrequency (RF) electrodes. These electrodes deliver sequential RF energy to the penile area, with additional electrodes on a pad applied to the perineal area to also cover the penile crus. We hypothesize that 1) RF energy raises penile temperature, enhancing erectile response, and 2) RF energy posits a direct structural and biochemical impact on tunical and corporal tissue, improving the tunical veno-occlusive mechanism. Objective The purpose of the current study is to evaluate the safety and efficacy of the VERTICA® investigational device for treatment of ED. Methods This study is a pivotal, prospective, randomized, controlled, double-blind clinical trial. Around 100, in our center 33 adult, heterosexual, and sexually active males (≥22 years) with mild to moderate and mild organic ED (IIEF EF score 11-21) will be enrolled and randomized 1:1 for Active or Sham VERTICA® treatment. Patients are instructed to use the device 3 times a week for 4 weeks (12 treatments), twice a week for an additional 4 weeks (8 treatments) and then 1-2 times a week for another 4 months. Every treatment comprises a 15-minute session involving ring electrodes, followed by an additional 15-minute session incorporating both ring and pad electrodes. Compliance and treatment data is monitored using a smartphone app. Subjects are instructed to attempt sexual activity weekly or 6 times a month, logging events in the Sexual Encounter Profile (SEP) form. Monthly follow-up assessments at months 1, 2, 3, and 6 include evaluating the efficacy of the treatment using the IIEF-EF, SEP, EHS, EDITS, and SHIM questionnaires. Enhancements in ED will be measured by comparing the scores of these questionnaires within both groups and, for every individual, before and after completing the study. Results A pilot study with 28 subjects demonstrated the device's safety and efficacy, with no serious adverse events reported in 144 treatment sessions. Conclusions In conclusion, the VERTICA® investigational device shows promise in the treatment of mild to moderate erectile dysfunction (ED) based on the pilot study and the ongoing pivotal clinical trial. If the results of this trial are promising, the VERTICA® device could offer a novel and effective treatment option for men with mild to moderate ED, potentially improving their quality of life and sexual health. Disclosure Yes, this is sponsored by industry/sponsor: Ohhmed. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: Sprout.