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This clinical trial aims to evaluate the safety and efficacy of spinal cord stimulation (SCS) in treating patients with urinary and bowel dysfunction after spinal cord injury (SCI). SCI is a highly disabling condition that can lead to sensory, motor, and autonomic nervous system dysfunction below the injury level. Neurogenic bladder and bowel dysfunction are common sequelae of SCI, seriously affecting patients' quality of life. Currently, clinical treatments can only partially alleviate urinary and bowel dysfunction, and more effective therapeutic approaches are still needed. Existing clinical studies have shown that SCS is gradually being applied to treat neurogenic bladder and bowel dysfunction in SCI patients. SCS can significantly improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in SCI patients, thereby enhancing their quality of life. The main questions this study aims to answer include: 1. Can this protocol help patients restore partial urinary and bowel function? 2. Besides the restoration of partial urinary and bowel function , can the SCS therapy could also help patients to restore the walking function.
Patients with urinary and bowel dysfunction more than 6 months after spinal cord injury will undergo epidural spinal stimulation electrode implantation surgery two weeks after functional assessment. Then the parameter optimization and rehabilitation will last for 6 months. The follow-up records and assessments will be conducted monthly at 2, 4, and 6 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation | Experimental | Participants will receive pre-implantation rehabilitation, evaluation, implantation of the spinal cord stimulator, and stimulation (according to the functional mapping) assisted rehabilitation post-implantation during the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation and Evaluation | Other | Patients with dysuria and defecation disorders due to spinal cord injury lasting over 6 months should undergo subdural spinal cord stimulation electrode implantation surgery two weeks after functional assessment. Device adjustment and parameter confirmation should be conducted four weeks after surgery. Follow-up assessments and examinations should be conducted monthly at 2, 4, and 6 months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic Bowel Dysfunction, NBD | This is a clinical symptom assessment scale for colorectal and anal dysfunction in patients with spinal cord injury. It consists of 10 items, including defecation frequency, defecation time, accompanying symptoms, medication status, etc. The maximum score is 47 points, and a score above 14 points indicates severe intestinal dysfunction. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Neurogenic Bladder Symptom Score, NBSS | Including three dimensions: urinary incontinence (8 items), urine storage and voiding (7 items), and outcomes (7 items), with a total of 24 items. Two items are non-scoring items. The first item is categorized based on the patient's bladder management method, and the last item is an overall quality of life assessment to evaluate the patient's voiding pattern and quality of life. Each item is scored from 0 to 3 points or 0 to 4 points. The total score of the scale is 74 points, with higher scores indicating more significant neurogenic bladder symptoms. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The Wexner Anorectal Incontinence Scale | It is a scale used to assess the severity of bowel movements in patients, applicable to patients with fecal incontinence caused by various reasons. The scale consists of 5 items, with a scoring range of 0-20 points. A higher score indicates a more severe degree of incontinence. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Lu, MD | Contact | +8656119530 | yanglu@btch.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yang Lu | Beijing Tsinghua Chang Gung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Chang Gung Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39366832 | Background | Zhang X, Lu Y, Zhang B, Li H, Yao Q, Lim J, Wei Y, He K, Zuo C, Sui Y, Ma B, Ran M, Pan Y, Wang G, Li L. Voluntary walking related joint movement training with targeted epidural electrical stimulation enabled neural recovery for individuals with spinal cord injury. Sci Bull (Beijing). 2024 Nov 30;69(22):3507-3511. doi: 10.1016/j.scib.2024.09.036. Epub 2024 Sep 26. No abstract available. |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Elimination Journal | A voiding diary is a semi-objective examination method. It is recommended to record for 2-3 days or more to obtain reliable results. This examination is non-invasive and reproducible, making it a recommended urinary system assessment for patients with spinal cord injury. The defecation diary includes information such as stool characteristics, frequency of defecation, defecation time, complete emptying sensation, difficulty in defecation, dietary conditions, and methods of assisted defecation. It is widely used in the assessment of diseases accompanied by defecation dysfunction. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Gastrointestinal Emptying Study | It is a first-line diagnostic method for gastric motility function. Patients need to orally ingest a certain amount of barium sulfate, and then the gastric emptying situation is observed to determine whether the peristaltic function of the gastrointestinal tract is normal. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Defecography | This is an examination method that involves injecting a contrast agent with the same volume and viscosity as normal feces into the rectum, and observing the morphological and functional changes of the anal canal and rectum during sitting, anal lifting, forceful defecation, and after fecal emptying. It belongs to dynamic X-ray imaging technology and is used to understand the defecation process. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Anorectal Manometry | This method involves placing a pressure measurement device into the rectum to measure the contraction and relaxation of the anus, examining the function and coordination of both the internal and external sphincters, pelvic floor, and rectum. It provides objective indicators for evaluating the anal canal and rectal sphincter function. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Urodynamic Study | One hour before the examination, please have the patient drink 500ml of water. Once the bladder is full and the patient feels the urge to urinate, proceed with the examination to measure the patient's urine flow rate and residual urine volume. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| 36-Item Short Form Health Survey，SF-36 | Including 36 items divided into 8 dimensions: physiological function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These dimensions fall under two major categories: physical health and mental health. The final score for each dimension ranges from 0 (lowest) to 100 (highest), with higher scores indicating better quality of life. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| 10-Meter Walk Test (10MWT) | assesses gait speed by timing a patient walking over a 10-meter (32.8 feet) distance, often measuring the central 6 meters to exclude acceleration/deceleration. It calculates speed in meters per second (m/s) to evaluate functional mobility, commonly for stroke or neurological conditions. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| Walking Index for Spinal Cord Injury II (WISCI II) | Measures walking in people with spinal cord injury, by the amount of physical assistance, braces or devices required to walk 10 meters. | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |