SCS Therapy for Patients With Bladder and Bowel Dysfunction After SCI

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Neurogenic Bowel Dysfunction, NBD [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Neurogenic Bladder Symptom Score, NBSS [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]

Secondary outcome measures (9)

• The Wexner Anorectal Incontinence Scale [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Elimination Journal [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Gastrointestinal Emptying Study [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Defecography [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Anorectal Manometry [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Urodynamic Study [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• 36-Item Short Form Health Survey，SF-36 [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• 10-Meter Walk Test (10MWT) [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]
• Walking Index for Spinal Cord Injury II (WISCI II) [Time frame: Two weeks before the implant surgery, and 2, 4, 6 months after the surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tsinghua Chang Gung Hospital — Beijing

Publications

• Zhang X, Lu Y, Zhang B, Li H, Yao Q, Lim J, Wei Y, He K, Zuo C, Sui Y, Ma B, Ran M, Pan Y, Wang G, Li L. Voluntary walking related joint movement training with targeted epidural electrical stimulation enabled neural recovery for individuals with spinal cord injury. Sci Bull (Beijing). 2024 Nov 30;69(22):3507-3511. doi: 10.1016/j.scib.2024.09.036. Epub 2024 Sep 26. No abstract available. PMID 39366832

Identifiers

NCT: NCT07511244 · 20241129

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗