A Novel High-Density Electromyography Probe for Evaluating Anorectal Neurophysiology: Design, Human Feasibility Study, and Validation with Trans-Sacral Magnetic Stimulation

Fecal incontinence (FI) substantially impairs quality of life and imparts a major socioeconomic burden. Anal sphincter injury and possibly pudendal nerve damage are considered common causes, however, current clinical methods for evaluating their function remain suboptimal. Electromyography (EMG) and pudendal nerve terminal latencies have been applied with some success, but are not considered standard practice due to uncertain accuracy and clinical value. In this study we developed and applied a novel anorectal high-density (HD) EMG probe in humans and pigs to acquire quantitative electrophysiological metrics of the anorectum. In the human trial we assessed somatic pathways and showed that EMG amplitude was greater for tight voluntary squeezes than light voluntary squeezes (0.03 ± 0.02 mV vs. 0.05 ± 0.03 mV). In a porcine model we applied trans-sacral magnetic stimulation to evoke extrinsically activated involuntary pathways and the resulting motor evoked potentials (MEP) were captured using the HD-EMG probe. The mean MEP amplitude at 50% magnetic stimulation intensity output (MSO) was significantly lower that the MEP amplitude at 85, 95 and 100% MSO (1.52 ± 0.50 mV vs. 3.10 ± 0.60 mV). In conclusion, the use of HD-EMG probe in conjunction with trans-sacral magnetic stimulation, for spatiotemporal mapping of anorectal EMG and MEP activity is anticipated to achieve new insights into FI and could offer improved diagnostic and prognostic biomarkers for anorectal dysfunction.