Reduction of Overactive Bladder Medications in Spinal Cord Injury With Self-Administered Neuromodulation: A Randomized Trial.

Abstract

Purpose: Our goal was to evaluate if self-administered bladder neuromodulation with transcutaneous tibial nerve stimulation could safely replace overactive bladder medications in people with spinal cord injury.

Materials and methods: We performed a 3-month, randomized, investigator-blinded, tibial nerve stimulation vs sham-control trial in adults with spinal cord injury and neurogenic bladder performing intermittent catheterization and taking overactive bladder medications. The primary outcome was a reduction in bladder medications while maintaining stable bladder symptoms and quality of life based on pre/post Neurogenic Bladder Symptom Score and the Incontinence Quality of Life questionnaire, respectively. Secondary outcomes included changes in pre/post cystometrogram, 2-day voiding diaries, and an anticholinergic medication side effect survey.

Results: Fifty people consented to the study, with 42 completing the trial. No dropouts were due to stimulation issues. All baseline demographics and surveys were comparable at baseline. Cystometrogram parameters were also comparable at baseline, except the stimulation group had a higher proportion of loss of bladder compliance compared to the control group. At the end of the trial, a significantly greater percentage of the tibial nerve stimulation group was able to reduce medications (95% vs 68%), by a 26.2% difference in medication reduction (95% CI 1.17%-51.2%). Function and quality of life surveys and cystometrograms at the end of the trial were alike between groups. Transcutaneous tibial nerve stimulation satisfaction surveys and adherence to protocol were high.

Conclusions: In people with chronic spinal cord injury performing intermittent catheterization, transcutaneous tibial nerve stimulation can be an option to reduce or replace overactive bladder medications.

Clinical Trial Registration No.: NCT03458871.