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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
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
Contact Information
Primary
Yang Lu, MD
yanglu@btch.edu.cn
+8656119530
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 10
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tsinghua Chang Gung Hospital

This content was sourced from clinicaltrials.gov

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