Short-term safety and preliminary patient-reported outcomes of bipolar radiofrequency therapy for mild-to-moderate erectile dysfunction: a prospective single-arm pilot study.

Background: Erectile dysfunction (ED) is a common condition with multifactorial etiologies, including vasculogenic, neurologic, endocrine, metabolic, psychogenic, medication-related, and postsurgical causes. Bipolar radiofrequency (RF) therapy is an emerging noninvasive energy-based approach with potential restorative relevance in ED, but clinical evidence remains limited. This study evaluated the short-term safety, feasibility, and preliminary patient-reported outcomes of bipolar RF therapy in men with mild-to-moderate organic ED. Methods: This prospective, single-arm, open-label pilot study enrolled men aged 40-80 years with mild-to-moderate organic ED. Participants underwent six weekly treatment sessions using a handheld bipolar RF device (Forma applicator, InMode MD Ltd.). The primary endpoint was change in the International Index of Erectile Function erectile function domain (IIEF-EF) from baseline to 1 and 3 months. Secondary endpoints included Erection Hardness Score (EHS), Global Assessment Questionnaire (GAQ), Sexual Encounter Profile (SEP), procedural discomfort measured by Numeric Pain Rating Scale (NPRS), and short-term safety assessed through adverse-event monitoring and directed symptom review. Results: Nineteen participants were enrolled, 18 contributed at least one post-baseline IIEF-EF assessment, and 17 completed baseline, 1-month, and 3-month IIEF-EF and EHS assessments. Two withdrawals were related to study burden and were not treatment-related. Mean IIEF-EF increased from 16.4±4.9 at baseline to 22.6±3.1 at 1 month and 23.7±3.1 at 3 months (overall P<0.001). Median EHS improved from 2.0 [interquartile range (IQR), 2.0-3.0] at baseline to 3.0 (IQR, 3.0-4.0) at both follow-up visits (overall P<0.001). At 1 month, all participants with available follow-up data reported improvement in erectile function and sexual activity on GAQ; at 3 months, 94.1% continued to report improvement in both domains. SEP Question 2 improved from 2/19 (10.5%) at baseline to 13/17 (76.5%) at 3 months, and SEP Question 3 improved from 2/19 (10.5%) to 12/17 (70.6%). No treatment-emergent adverse events or serious adverse events were documented. Mean procedural discomfort was 0.18±0.73, with a median of 0.0; all recorded discomfort scores were mild. Conclusions: In this prospective pilot study, bipolar RF therapy was feasible and well tolerated and was associated with favorable short-term improvements in patient-reported erectile function outcomes in men with mild-to-moderate organic ED. Given the single-arm, open-label design and short-term follow-up, these findings should be considered preliminary and hypothesis-generating. Larger sham-controlled studies with longer follow-up and objective physiologic endpoints are needed to define durability and clinical relevance.