An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial.

Erectile dysfunction (ED) affects approximately 150 million men worldwide. Functional electrical stimulation (FES) therapy has shown a high regenerative capacity for smooth muscle cells and, therefore, is being increasingly adopted. FES can be a beneficial treatment option when the cause of ED is related to degeneration of cavernous smooth muscle. To evaluate the impact of FES on erectile function in men with erectile dysfunction. Twenty-two patients with ED participated in this randomized clinical trial. Participants were randomly assigned to two groups: intervention (IG) or control (CG). IG participants underwent FES therapy (50 Hz/500 µs) for a total of 4 weeks, divided into two weekly sessions lasting 15 min each, with intensity lower than the motor threshold. CG participants were treated with placebo FES and followed the same routine as the IG. Erectile function was assessed by the validated International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS), applied before and after treatment, and quality of life, by the WHOQOL questionnaire. Statistically significant differences in IIEF-5 and EHS were found between the IG and CG after treatment (p <  0.05), as well as a within-group difference in the IG when comparing the post-treatment periods (p < 0.0001) The WHOQOL revealed a significant difference between CG and IG after treatment (p < 0.05), as well as a within-group difference in the IG after treatment (p < 0.0001), except in the Environment domain, in which there was no difference between the pre- and post-treatment periods (50.9 ± 2.8 pre vs. 52.3 ± 3.1 post). This trial showed that FES therapy may improve erectile function and quality of life in men with ED.