Spinal cord stimulation for bladder and bowel problems after spinal cord injury
Clinical Trial on the Safety and Efficacy of Spinal Cord Stimulation Therapy for Patients With Bladder and Bowel Dysfunction After Spinal Cord Injury
This project will test spinal cord stimulation to see if it helps people with bladder and bowel problems after a spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Beijing Tsinghua Chang Gung Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07511244 on ClinicalTrials.gov |
What this trial studies
This interventional protocol uses implanted spinal cord stimulation (SCS) to try to improve neurogenic bladder and bowel function in adults with spinal cord injury. Eligible participants are adults 18–60 years old, at least six months post-injury, with AIS grade A–D, who are medically stable and able to complete follow-up. Participants will undergo SCS implantation and programming, with follow-up visits to measure urinary efficiency, bladder capacity, compliance, detrusor pressure, bowel function, and safety outcomes. The approach builds on earlier, smaller clinical reports suggesting SCS can improve bladder and bowel parameters but aims to provide more systematic data on benefit and risks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–60 who are more than six months post-spinal cord injury (AIS A–D), medically stable, able to undergo surgery and follow-up, and willing to provide informed consent.
Not a fit: Patients with severe autonomic reflex disorders, significant cognitive or psychiatric impairments preventing cooperation, inability to undergo surgery or follow-up, or those with very recent injuries (<6 months) may not benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could improve bladder and bowel control and quality of life for people with spinal cord injury.
How similar studies have performed: Early clinical reports and small series have shown that SCS can improve urinary efficiency, bladder capacity, compliance, and detrusor pressure in some patients, but larger controlled data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Beijing Tsinghua Chang Gung Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Yang Lu — Beijing Tsinghua Chang Gung
- Study coordinator: Yang Lu, MD
- Email: yanglu@btch.edu.cn
- Phone: +8656119530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.