Conditional neuromodulation of neurogenic detrusor overactivity using transrectal stimulation in patients with spinal cord injury: A proof of principle study.

Sarah Louise Knight,Michael Duncan Craggs,Nuwani Edirisinghe,Brian Leaker,Judith Susser

doi:10.1002/nau.23310

Sarah Louise Knight, Michael Duncan Craggs + Show 3 more

Open Access

https://doi.org/10.1002/nau.23310

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Abstract

AimsA proof of principle study of a novel wearable device to control neurogenic detrusor over‐activity in eight male spinal cord injured subjects using conditional neuromodulation.MethodsTransrectal stimulation was delivered through the device in response to simultaneously recorded external anal sphincter (EAS) contraction as a marker for neurogenic detrusor overactivity (NDO). The effect of conditional neuromodulation on bladder capacity and maximum detrusor pressure was investigated in addition to reliability of dyssynergic sphincter contraction as a marker for NDO.ResultsConditional neuromodulation through the novel device showed a statistically significant increase in bladder capacity and reduction in maximum detrusor pressure in six male subjects with spinal cord injury (SCI). EAS activity was a reliable surrogate for detection of NDO.ConclusionsIt has been shown for the first time that conditional neuromodulation can be delivered and triggered via a single biocompatible device placed in the anal canal. The pudendal nerves lying in Alcock's canal were stimulated through the wall of the anal canal, and the dyssynergic activity of the EAS was used to detect NDO and trigger neuromodulation giving significant increases in bladder capacity and reduction in detrusor pressure in six male subjects with SCI.

Highlights

Following a supra-sacral spinal cord injury (SCI), there are profound alterations in bladder function which usually result in incontinence secondary to neurogenic detrusor overactivity (NDO) and associated detrusor sphincter dyssynergia (DSD).[1]
The pudendal nerves lying in Alcock's canal were stimulated through the wall of the anal canal, and the dyssynergic activity of the external anal sphincter (EAS) was used to detect NDO and trigger neuromodulation giving significant increases in bladder capacity and reduction in detrusor pressure in six male subjects with SCI
We describe a proof of principle study of a novel, patented,[20] wearable, and biocompatible conditional neuromodulation (CN) device to control NDO which overcomes some of the disadvantages of implanted continuous neuromodulation devices

Summary

| INTRODUCTION

Following a supra-sacral spinal cord injury (SCI), there are profound alterations in bladder function which usually result in incontinence secondary to neurogenic detrusor overactivity (NDO) and associated detrusor sphincter dyssynergia (DSD).[1]. The ultimate goal in the urological management of patients with NDO and DSD is to increase bladder capacity and reduce bladder pressures, in order to protect the upper tracts and minimize incontinence At present, this can be achieved using pharmacological methods, surgical procedures, or with the use of implanted electrical stimulation devices in combination with catheterization of the bladder.

| MATERIALS AND METHODS

| RESULTS

| DISCUSSION

| Study limitations and outlook

Findings

| CONCLUSIONS