Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living with Spinal Cord Injury
Abstract
In spinal cord injury (SCI), nerves that communicate between the brain and body are damaged. In addition to weakness and numbness, other functions are often impacted, including the digestive track. For people living with SCI, bowel control and dysfunction are among their biggest perceived challenges. Despite numerous medications and time-consuming routines, constipation and incontinence are still common. More research and innovative tools are needed. One such approach is genital nerve stimulation (GNS). GNS involves electrodes (sticky pads) placed on the skin to stimulate the nerves in the pelvis. Studies have shown that treatments with GNS can help calm and change the reflexes involved in urinating, resulting in fewer bladder accidents. Early data suggests that GNS can also improve bowel function by changing the reflexes used to defecate. By relaxing the colon, GNS may allow better storage of stool with fewer bowel accidents. An earlier study showed that GNS reduces incontinence in persons with unexplained fecal incontinence. So, it is reasonable to believe that GNS will help improve bowel control after SCI. The goal of this study is to evaluate the short-term effect of GNS on the reflexes used to defecate and the practicality of using GNS daily at home to test the long-term effects. To evaluate for an effect on bowel control from GNS, participants will have a test called anorectal manometry (ARM). In addition, the study hopes to show GNS is a feasible option to improve bowel dysfunction, bowel incontinence, and quality of life in persons with SCI. This study involves two parts. In the first part, 52 persons with SCI from trauma (such as car crashes or falls) will be enrolled. During one or two study visits, each participant will be evaluated using physical exams, interviews, and ARM evaluations. Their response to low level (sham) and high level (treatment) GNS will be tested. Person-related outcomes for this part of the study will be available immediately for each participant and near the beginning of grant year 3 for all 52 participants. In the second part, 12 people who responded well to GNS in the first part will be enrolled. All participants will maintain their usual bowel routine and nutritional habits while completing a daily diary of their bowel movements. Each participant will be re-evaluated using physical exams, interviews, and ARM evaluations, and will then be randomly assigned to the treatment group or the sham group. All participants will be trained to perform GNS at home, every day for 6-8 hours over four weeks. The sham group will have devices programmed to deliver ineffective stimulation, whereas the treatment group will receive effective stimulation. After 4 weeks, both groups will be reevaluated. Each person will not do any stimulation for another 2 weeks before being re-evaluated a final time. Person-related outcomes for this part of the study will be available by the end of grant year 4. It is a high priority to individuals living with SCI to regain autonomic function such as bowel control. Bowel dysfunction has a significant impact on daily routines, social activities, and occupational activities, all of which impact quality of life. This trial will directly aid in our understanding and ability to treat bowel dysfunction related to spinal cord injuries. People living with SCI have expressed interest in external stimulation to improve fecal continence and overall bowel routine. This trial will help show if GNS is practical for people with SCI. It is low risk (such as skin irritation or constipation, though this is unlikely) with high potential benefits (such as fewer bowel accidents and faster bowel routines). If successful, a larger future study will provide even stronger evidence for GNS to be included in normal clinical practice. Information learned should help us understand how the ARM evaluation looks in individuals with SCI and how it relates to fecal incontine
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210778
Entities
People
- Kimberly Anderson
Organizations
- Case Western Reserve University
- United States Army