NCT04350359 · The University of Texas Health Science Center, Houston
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
(TTNS1yr)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Variable-dose TTNS Protocol 5 x week
Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
DEVICE
Fixed-dose TTNS Protocol
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
DEVICE
Variable-dose TTNS Protocol 2 x week
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
Primary outcome measures
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time frame: Baseline
we expect bladder capacity to be maintained in those with effective TTNS
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
Time frame: 4 months post SCI
we expect bladder capacity to be maintained in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: Baseline
Evidence of TTNS mechanism expected in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: 4 months post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
Time frame: 1 year post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
Time frame: Baseline, 4 months
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.
Time frame: 4 months and 1 year post SCI
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on the change in urodynamic studies at 4 months and 1-year
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.)
- 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
- Washington D.C., District of Columbia
- Houston, Texas
Collaborators
MedStar National Rehabilitation Network, The Methodist Hospital Research Institute
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations