At-home feasibility trial of genital nerve stimulation to modulate neurogenic bowel dysfunction in individuals living with spinal cord injury: a protocol.

INTRODUCTION: Neurogenic bowel dysfunction is a consequence of almost all spinal injuries. Primary management is via conservative treatment methods with few intermediary interventions available prior to surgical management. This protocol describes a trial to determine if genital nerve stimulation (GNS) can reliably be delivered at-home for the purpose of modulating neurogenic bowel dysfunction in people living with spinal cord injury (SCI). METHODS AND ANALYSIS: A total of 12 participants, aged 18 years or older with any severity of a traumatic SCI (at least 6 months post-injury) at or above the neurological level of T12 with severe neurogenic bowel dysfunction will be enrolled, randomized, and perform GNS or sham stimulation 6-8 h per day for 4 weeks. Daily bowel and stimulation diaries will be filled out by participants or caregivers to provide qualitative and feasibility data. Anorectal manometry (ARM) assessments will be performed at Baseline (before stimulation), at the End of Treatment (the next day after cessation of at-home stimulation), and at the End of Study (after 2 weeks of no stimulation). ARM assessments provide quantitative data for changes in anal sphincter and rectal function due to stimulation. Self-report questionnaires will be completed at each ARM assessment regarding neurogenic bowel dysfunction and impacts of bowel function on quality of life. DISCUSSION: Outputs from this trial will inform research and clinical practice on the preliminary neuromodulatory effects of GNS on SCI-induced neurogenic bowel dysfunction and will guide the development of a properly powered efficacy trial testing GNS as an intermediary intervention. ETHICS AND DISSEMINATION: The study was approved by the MetroHealth Institutional Review Board (STUDY00000717) and registered at clinicaltrials.gov prior to enrollment of participants. Dissemination of results will be through presentations at academic meetings and in the community, and peer-reviewed medical journals. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT06836739, identifier NCT06836739.