Aims: A 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. Methods: Transrectal 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. Results: Conditional 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. Conclusions: It 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. K E Y W O R D S neurogenic detrusor over-activity, neuromodulation, spinal cord injuryThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.© 2017 The Authors. Neurourology and Urodynamics Published by Wiley Periodicals, Inc.Abbreviations: AD, autonomic dysreflexia; CN, conditional neuromodulation; DP, detrusor pressure; DSD, detrusor sphincter dyssynergia; EAS, external anal sphincter; EAS EMG, external anal sphincter electromyogram; EMGthresh.min, value of EAS EMG at which CN would be triggered; EUS, external urethral sphincter; iSCI, incomplete spinal cord injury; MCC, maximum cystometric capacity; MDP, maximum detrusor pressure; NDO, neurogenic detrusor overactivity; PPV, positive predictive indicator; SCI, spinal cord injury; T NDO , time at which detrusor pressure exceeded 15 cmH 2 O.John Heesakkers led the peer-review process as the Associate Editor responsible for the paper.Neurourology and Urodynamics. 2018;37:385-393.wileyonlinelibrary.com/journal/nau | 385
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