Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Neurogenic Bowel Dysfunction, NBD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Spinal Cord Stimulation
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.
干预措施: Spinal Cord Stimulation and Evaluation (Other)
结局指标
主要结局
Neurogenic Bowel Dysfunction, NBD
时间窗: 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
时间窗: 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.
次要结局
- The Wexner Anorectal Incontinence Scale(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Urodynamic Study(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Elimination Journal(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Gastrointestinal Emptying Study(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Defecography(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Anorectal Manometry(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- 36-Item Short Form Health Survey，SF-36(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- 10-Meter Walk Test (10MWT)(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
- Walking Index for Spinal Cord Injury II (WISCI II)(Two weeks before the implant surgery, and 2, 4, 6 months after the surgery)
研究者
Yang Lu
Attending Physician of Beijing Tsinghua Changgung Hospital
Beijing Tsinghua Chang Gung Hospital