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.
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.
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.
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.
Translational andrology and urology. 2026 Jun 17 [Epub]
Robert J Valenzuela, Lanna Cheuck, Alexander Negron, Ben Tran, Fernanda Saverio-Rodriguez
Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY, USA., LC Medical PLLC and Surgical Practice, New York, NY, USA., New York Health, New York, NY, USA., Fairfield University, Fairfield, CT, USA., Universidad Católica de Santiago de Guayaquil, Facultad de Ciencias de la Salud, Guayaquil, Ecuador.