Actively Recruiting
SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI
Led by Beijing Tsinghua Chang Gung Hospital · Updated on 2026-04-06
10
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old
- Spinal cord injury classified as AIS Grade A, B, C, or D
- Injury duration longer than 6 months
- Stable and healthy condition, able to complete the study and cooperate with examinations
- Voluntary participation and ability to sign informed consent
- Good compliance and willingness to follow up during the study period
You will not qualify if you...
- Patients with obvious mental illnesses or unable to complete subjective scoring
- Patients with mental or cognitive disorders unable to cooperate with surgery or follow-up
- Patients with severe autonomic reflex disorders
- Patients unable to undergo spinal cord stimulation surgery or follow-up
- Patients with progressive spinal instability or severe spinal deformities
- Patients with life expectancy less than one year
- Patients with abnormal blood tests or unable to tolerate surgery
- Patients with uncontrolled hypertension, severe heart or respiratory diseases, or recent related medication use
- Patients with severe hydronephrosis or renal function disorders
- Patients with urethral sphincter or bladder dysfunction before spinal cord injury
- Patients with history of pelvic radiotherapy, bladder cancer, or bladder surgeries affecting bladder physiology
- Patients considered inappropriate by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tsinghua Chang Gung Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yang Lu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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