Bladder and Bowel Dysfunction, SCI - Spinal Cord Injury
Conditions
Keywords
Bladder and Bowel Dysfunction, Spinal Cord Injury
Brief summary
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.
Interventions
OTHERSpinal Cord Stimulation and Evaluation
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.
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 to 60 years old * Spinal Cord Injury Classification: AIS Grade A, B, C, or D * Injury Duration: \> 6 months * Stable and healthy condition, as determined by the investigator; able to complete the entire study period and cooperate with examinations * Voluntary participation in clinical trial and ability to sign informed consent form * Good patient compliance, willing and able to follow follow-up requirements during the follow-up period
Exclusion criteria
* Mental Disorders Patients with obvious mental illnesses (such as anxiety, depression, etc.) who are unable to complete relevant subjective scoring. * Mental and Cognitive Impairments Patients with mental or cognitive disorders who are unable to cooperate with surgeries, undergo programming procedures, or complete follow - up. * Autonomic Reflex Disorders Patients with severe autonomic reflex disorders. * Inability in Surgical and Follow - up Processes Patients who are unable to undergo spinal cord stimulation surgery or cooperate with follow - up. * Spinal Abnormalities Patients accompanied by progressive spinal instability or severe spinal deformities. * Life Expectancy Patients with an expected lifespan of less than one year. * Laboratory Abnormalities and Surgical Tolerance Patients with abnormal blood routine, blood biochemistry, etc., and are clinically judged to be unable to tolerate surgery, such as those with coagulation disorders, abnormal liver and kidney function. * Cardiovascular and Respiratory Diseases Patients with uncontrolled hypertension, severe heart diseases, or severe internal medicine and respiratory system diseases, or those who have regularly taken medications related to hypertension and heart diseases within the recent three months. * Renal Disorders Patients with severe hydronephrosis or renal function disorders. * Urogenital Function Disorders before Spinal Cord Injury Patients with pre - existing urethral sphincter or bladder dysfunction before spinal cord injury. * History of Pelvic Surgery and Radiotherapy Patients with a history of pelvic radiotherapy, bladder cancer, or other bladder surgeries that affect the basic bladder physiology. * Other Inappropriate Cases Patients considered inappropriate by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurogenic Bowel Dysfunction, NBD | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Neurogenic Bladder Symptom Score, NBSS | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Wexner Anorectal Incontinence Scale | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Elimination Journal | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Gastrointestinal Emptying Study | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Defecography | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Anorectal Manometry | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Urodynamic Study | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| 36-Item Short Form Health Survey，SF-36 | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| 10-Meter Walk Test (10MWT) | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | 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. |
| Walking Index for Spinal Cord Injury II (WISCI II) | Two weeks before the implant surgery, and 2, 4, 6 months after the surgery | Measures walking in people with spinal cord injury, by the amount of physical assistance, braces or devices required to walk 10 meters. |
Countries
China
Contacts
CONTACTYang Lu, MD
PRINCIPAL_INVESTIGATORYang Lu
Beijing Tsinghua Chang Gung
Outcome results
None listed