Last updated on May 2019

Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury

Brief description of study

In the first 3 months after spinal cord injury, patients will be randomized to receive and implantable sacral neuromodulator that will stimulate bilateral S3 nerve roots. These patients will be compared to those receiving standard neurogenic bladder care. Multiple primary and secondary endpoints will be compared based upon urodynamic parameters, quality of life measurements, and clinical outcomes.

Detailed Study Description

AIM 1: To determine the effect of sacral neuromodulation on urodynamic parameters following acute spinal cord injury. The following outcomes will be evaluated by urodynamic assessment at one year post-SCI: (1) maximum cystometric capacity, (2) bladder compliance, (3) presence of detrusor overactivity, and (4) volume and pressure for first detrusor contraction.

AIM 2: To assess the impact of sacral neuromodulation on patient-reported quality of life after acute spinal cord injury. Patient-reported QoL will be assessed using the SCI-QOL bladder question bank and bladder/voiding diaries. Mean SCI-QOL score, daily number of catheterizations, average catheterization volume, and episodes of incontinence per day will be compared between groups at one year post-SCI.

AIM 3: To examine the impact of sacral neuromodulation on quantifiable clinical outcomes. Patients will be followed longitudinally during the study period and assessed for the following: (1) need for anti-cholinergic medications and/or onabotulinum toxin A treatment, (2) number of symptomatic UTIs per year, (3) complications attributable to the device, (4) need for revision of device or leads due to lead migration or failure, (5) development of hydronephrosis.

Clinical Study Identifier: NCT03083366

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