Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury

BMC Urology
Jeffrey D RedshawNeurogenic Bladder Research Group (NBRG.org)

Abstract

Neurogenic bladder (NGB) dysfunction after spinal cord injury (SCI) is generally irreversible. Preliminary animal and human studies have suggested that initiation of sacral neuromodulation (SNM) immediately following SCI can prevent neurogenic detrusor overactivity and preserve bladder capacity and compliance. We designed a multicenter randomized clinical trial to evaluate the effectiveness of early SNM after acute SCI. The scientific protocol comprises a multi-site, randomized, non-blinded clinical trial. Sixty acute, acquired SCI patients (30 per arm) will be randomized within 12 weeks of injury. All participants will receive standard care for NGB including anticholinergic medications and usual bladder management strategies. Those randomized to intervention will undergo surgical implantation of the Medtronic PrimeAdvanced Surescan 97,702 Neurostimulator with bilateral tined leads along the S3 nerve root in a single-stage procedure. All patients will undergo fluoroscopic urodynamic testing at study enrollment, 3 months, and 1-year post randomization. The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year. After accounting for a 15% loss to follow-up, we expect 25 evaluable patients per arm (50...Continue Reading

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Citations

Feb 7, 2019·Physiology·Charles C HornLee E Fisher
Mar 19, 2019·The Journal of International Medical Research·Fang TangJinying Guan
Nov 28, 2019·Cell Biology International·Ning ZhuMarong Fang
Oct 23, 2019·Journal of Cellular and Molecular Medicine·Liuqin JiangHairong Xu
Sep 25, 2019·Topics in Spinal Cord Injury Rehabilitation·Elizabeth Lucas
May 20, 2020·Current Opinion in Urology·F M J Martens, K-D Sievert
Aug 8, 2019·Current Urology Reports·Courtenay K MooreSamir Derisavifard
May 16, 2020·Neuromodulation : Journal of the International Neuromodulation Society·Alaa Abd-ElsayedWeston Nadherny
Feb 17, 2021·Journal of Neural Engineering·Marina CracchioloSilvestro Micera

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Clinical Trials Mentioned

NCT03083366

Software Mentioned

InterStim

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