SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI

NCT07511244 · tracked via the Priya Life Science China tracker

Sponsor

Beijing Tsinghua Chang Gung Hospital

Phase

Not applicable

Started

2024-12-01

Last updated

2026-04-06

Condition(s) studied

Bladder and Bowel DysfunctionSCI - Spinal Cord Injury

Investigational drug(s) / intervention(s)

Spinal Cord Stimulation and Evaluation

Spinal 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

60 Years

Healthy volunteers

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.

Primary outcome measure(s)

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.

Trial sites (1)

Facility	City	Region	Status
Beijing Tsinghua Chang Gung Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07511244 on ClinicalTrials.gov ↗ ← All trials in China