Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
MetroHealth Medical Center
Summary
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.
Description
Time commitment: A person who participates in this study will have the option of coming in for one or two visits (for a total of about 7.5 hours). Descriptions below will separate the research activities into two visits for clarity. Minimizing barriers to participation: 1. \- If you live in the region (Cuyahoga, Lorain, Medina, Lake, or Geauga counties of Ohio) and need assistance with transportation to get to and from the research site for a visit, the study team will make these arrangements at no cost to you. If you live outside of the region, the study team will reimburse your transportat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 wi…
Interventions
- DeviceGenital Nerve Stimulation
Electrical stimulation applied to the genital nerve with surface electrodes using an off the shelf TENS unit (Ultima Plus). First, an amplitude threshold for the pudendo-anal reflex responses will be determined. Then, sham (1-2 Hz) and effective stimulation (20 Hz) will be briefly applied to record responses. Then, stimulation will be applied in random presentation order to record any changes in anorectal manometry outcomes due to both sham and effective stimulation.
- Diagnostic TestClinical exam
Examination by physician determines the presence of pelvic reflexes (pudendo-anal and bulbocavernosus) which are essential for GNS to have an effect.
- Diagnostic TestCollection of SCI common data elements
Data regarding participant demographics, history of injury, and medical history will be collected.
- Diagnostic TestBowel function survey completion
Two surveys will be conducted to assess the bowel function of the participant. The International SCI Bowel Function Basic Data Set (ISCI BF BDS v2.1) and the SCI Qulaity of Life Bowel Management Difficulties (SCI-QoL BMD) survey scales collect data on overall bowel function and how any difficulties impact the participants quality of life.
Location
- MetroHealth Medical System Old Brooklyn CampusCleveland, Ohio