Transcutaneous electrical neural stimulation in patients with erectile dysfunction: a single arm pilot study

Extract

Erectile dysfunction (ED) is a common condition marked by the inability to achieve or sustain an erection suitable for satisfactory sexual activity¹. Age-related factors, such as smooth muscle loss and increased fibrosis, can restrict the expansion of the corpus cavernosum, complicating the restriction of venous drainage². The balance between blood inflow and outflow is essential for achieving and sustaining an erection, underscoring the complexity of erectile physiology. Transcutaneous electrical neural stimulation (TENS) therapy, known for enhancing blood flow and muscle contraction in striated muscles, shows promise for ED by potentially increasing penile blood flow and improving pelvic floor muscle (PFM) tone, thus reducing venous outflow. Our pilot study aimed to evaluate the effects of penile TENS therapy on ED symptoms and erectile function (EF), assessing its potential as a non-invasive ED treatment.

Ten patients diagnosed with ED from a single men’s health clinic were included. Patients were enrolled on a first-come, first-served basis, and meeting eligibility criteria until the target sample size was reached. This sample size was chosen to assess feasibility and collect preliminary data on the intervention’s potential effects. Inclusion and exclusion criteria are outlined in Table S1. No washout of current ED medications was required; patients were advised to maintain their regimen during the study. The institutional review board approved the protocol (H-51959), and all patients provided written informed consent. Baseline International Index of EF (IIEF) scores were recorded prior to the intervention. Device intensity levels and adverse events were monitored at each session. The treatment protocol consisted of 10 therapy sessions over five weeks (two sessions per week, each 20 minutes). Post-treatment assessments were conducted immediately after therapy, and at 1-month and 3-month follow-ups to evaluate outcomes.