Introduction The factors that impact external anal sphincter (EAS) recruitment in clinical pudendal neuromodulation are not well understood. Therefore, the goal of this study was to identify and quantify physiological, demographic, and stimulation factors that significantly affect EAS recruitment in participants receiving pudendal neuromodulation for treatment of lower urinary tract symptoms.

Methods Demographic and diagnostic information were collected from participants upon entry to the study. MRI and CT were used to capture patient pudendal nerve anatomy and register the location of the implanted lead. EAS activation by pudendal nerve stimulation at different amplitudes and pulse widths was recorded during neurostimulator lead implantation in the operating room. Linear mixed modeling was used to quantify the impact each variable had on EAS recruitment in the sixteen enrolled participants.

Results Participant sex, age, and BMI did not significantly affect EAS recruitment with pudendal nerve stimulation. Participant diagnoses had significant relationships to EAS recruitment, likely due to unbalanced group sizes. A pulse width of 210 μs required significantly less current than 60 μs (p = 0.005) to activate the EAS at threshold and significantly less charge than 450 μs (p = 0.02) to activate the EAS at threshold. Increased distance between the stimulating electrode and the pudendal nerve decreased the magnitude of the EAS response (p = 0.0011) and increased EAS activation threshold (p < 0.001).

Conclusions Of the three tested pulse widths, 210 μs requires the least charge and is a good choice for stimulation. The distance between the electrode and pudendal nerve plays an important role in EAS and pudendal nerve recruitment and minimizing this distance should be a priority during lead implantation.

The authors have declared no competing interest.

NCT04236596

This project was funded through the NIH SPARC program (award OT2OD028191).

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The study design was approved by the University of Michigan Institutional Review Board (HUM00165005).

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Data availability statement The data set from the study will be found on the SPARC Science data portal at DOI: 10.26275.pc8r-r3iu after completing the SPARC curation process.

Funding statement This project was funded through the NIH SPARC program (award OT2OD028191).

Clinical trial registration This study was registered at clinicaltrials.gov (NCT04236596).

The data set from the study will be found on the SPARC Science data portal at DOI: 10.26275.pc8r-r3iu after completing the SPARC curation process.

https://doi.org/10.26275/pc8r-r3iu