Electric stimulation to improve bladder function in spinal cord injury patients
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
NA · The University of Texas Health Science Center, Houston · NCT04350359
This study is testing if a new type of electric stimulation can help people with spinal cord injuries improve their bladder control and reduce incontinence.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT04350359 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of transcutaneous tibial nerve stimulation (TTNS) in enhancing bladder outcomes for individuals with spinal cord injuries (SCI) who experience neurogenic bladder. Participants will be randomized to receive either a fixed-dose or variable-dose of TTNS, administered at different frequencies (2 days vs. 5 days weekly). The study aims to assess the impact of these stimulation protocols on incontinence prevention and overall bladder management. Surveys will also be collected to evaluate participant characteristics and adherence to treatment throughout the study duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with traumatic or non-traumatic spinal cord injuries at the T9 level or above, admitted to rehabilitation within 6 weeks.
Not a fit: Patients with a history of genitourinary disorders, central nervous system disorders, or peripheral neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bladder control and quality of life for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown promise with tibial nerve stimulation for bladder control, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years old * Traumatic or non-traumatic SCI * Admitted to inpatient rehabilitation within 6 weeks * T9 level of injury and above who are at greatest risk of morbid NGB * Regionally located to allow follow-up * English or Spanish speaking Exclusion Criteria: * History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.) * History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.) * History of peripheral neuropathy * pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.) * Pregnancy * Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy * concern for tibial nerve pathway injury * absence of toe flexion or autonomic dysreflexia during electric stimulation test * Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- MedStar National Rehabilitation Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- TIRR Memorial Hermann Research Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Argyrios Stampas, MD — UTHealth and TIRR Mermorial Hermann
- Study coordinator: Argyrios Stampas, MD
- Email: argyrios.stampas@uth.tmc.edu
- Phone: 713-797-5938
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.
Conditions: Spinal Cord Injuries, electric stimulation, SCI, spinal cord injury, neurogenic bladder