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

This study investigates a new approach to managing bladder problems after a spinal cord injury (SCI). Typically, bladder dysfunction after SCI is permanent. The study is testing whether early use of sacral neuromodulation (SNM), a type of nerve stimulation, can help prevent severe bladder issues. The trial involves two groups of SCI patients: one receiving standard bladder care, and the other receiving standard care plus SNM. SNM involves surgically implanting a device that stimulates the sacral nerves, which control bladder function. The goal is to see if early SNM can improve bladder capacity, reduce bladder spasticity, and enhance the overall quality of life for SCI patients compared to standard treatments alone.

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  The primary outcome will be changes in urodynamic maximum cystometric capacity at 1-year.
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  The study also aims to quantify improvements in patient-reported quality of life, daily catheterization needs, and the incidence of urinary tract infections.
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  An interim analysis will be conducted at 50% enrollment (N = 26 after loss to follow-up, 13 patients per arm) accrual, and the decision to stop early will be governed by a significance level of 0.003.