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

   
@article{TAU155420,
	author = {Robert J. Valenzuela and Lanna Cheuck and Alexander Negron and Ben Tran and Fernanda Saverio-Rodriguez},
	title = {Short-term safety and preliminary patient-reported outcomes of bipolar radiofrequency therapy for mild-to-moderate erectile dysfunction: a prospective single-arm pilot study},
	journal = {Translational Andrology and Urology},
	volume = {15},
	number = {6},
	year = {2026},
	keywords = {},
	abstract = {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},
	issn = {2223-4691},	url = {https://tau.amegroups.org/article/view/155420}
}