NCT07511244

SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI

Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder and Bowel Dysfunction
• SCI - Spinal Cord Injury

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-12-01
• Primary completion: 2029-12-01
• Completion: 2029-12-31
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: China