Status:
RECRUITING
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
MedStar National Rehabilitation Network
The Methodist Hospital Research Institute
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
Detailed Description
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04350359
Start Date
June 8 2020
End Date
July 1 2026
Last Update
July 14 2025
Active Locations (2)
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1
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States, 20010
2
TIRR Memorial Hermann Research Center
Houston, Texas, United States, 77030