Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.
Traumatic SCI
Minimum 6 months post-injury
Aged 18 years or older
Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI
Currently enrolled in another functional electrical stimulation (FES) research trial
Females who are pregnant or planning to become pregnant during the trial
Presence of cardiac pacemaker, implanted defibrillator or other implanted FES device if, upon clinical exam, it may have an interaction with GNS.
In the judgement of the PI or Co-Investigators, presence of medical complications that may interfere with the execution of the study.
MetroHealth Medical Center
Lead sponsor
VA of Northeast Ohio Health System
Collaborator
Congressionally Directed Medical Research Programs
Collaborator