Improving bladder function in spinal cord injury patients using neuromodulation
Improving Bladder Function in SCI by Neuromodulation
This study is testing if new electrical and magnetic treatments can help people with spinal cord injuries improve their bladder control and function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Male |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT02331979 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of spinal cord neuromodulation techniques, specifically transcutaneous electrical stimulation and magnetic stimulation, to enhance urinary bladder function in individuals with spinal cord injury. Participants will undergo these neuromodulation interventions to assess improvements in bladder control and function. The study aims to provide a non-invasive treatment option for neurogenic bladder issues associated with spinal cord injuries.
Who should consider this trial
Good fit: Ideal candidates are males aged 18-45 who are at least one year post spinal cord injury and have a neurogenic bladder requiring catheterization.
Not a fit: Patients with a history of autonomic dysreflexia, significant musculoskeletal dysfunction, or those who have undergone certain bladder surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder function and quality of life for patients with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using neuromodulation techniques for bladder function improvement, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male 18-45 years; 2. At least 1 year post-injury; 3. Non-progressive SCI at C2-T8 (non-conus injury); 4. Motor Complete ASIA (A or B); 5. Neurogenic bladder requiring clean intermittent straight catheterization; 6. Able to attend twice weekly testing sessions for 6 months. 7. Have intact lower extremity anatomy and able to use lower extremity for assistive standing and stepping. Exclusion Criteria: 1. History of autonomic dysreflexia; 2. Ventilator dependency; 3. Musculoskeletal dysfunction, unhealed fracture, pressure ulcer, active infection; 4. Clinically significant depression or ongoing drug abuse; 5. Received botox injection, or bladder surgery (suprapubic access, Brindley procedure, etc.); 6. Prostatic hypertrophy or bladder outlet disorder; 7\. Cardiopulmonary disease that precludes lower extremity training or rehabilitation.
Where this trial is running
Los Angeles, California
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Daniel Lu, MD PhD
- Email: dclu@mednet.ucla.edu
- Phone: 310-825-4321
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.