Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
About this trial
This is an interventional treatment trial for Fecal Incontinence focused on measuring bowel, spinal cord injury, electrical stimulation, anorectal manometry, incontinence, tetraplegia, paraplegia, paralysis
Eligibility Criteria
Inclusion Criteria: 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 Response to genital nerve stimulation upon screening Able to understand and provide informed consent Exclusion Criteria: 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.
Sites / Locations
- MetroHealth Medical System Old Brooklyn CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
All interventions, Sham applied first
All interventions, effective stim applied first
These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.
These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.