CompletedNot Applicable

Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

United States111 participantsStarted 2020-06-08

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

Timeframe: Baseline

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

Timeframe: 4 months post SCI

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: Baseline

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: 4 months post SCI

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: 1 year post SCI

Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.

Timeframe: Baseline, 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.

Trial details

NCT IDNCT04350359

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-11

View on ClinicalTrials.gov More Spinal Cord Injuries trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

Timeframe: Baseline

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

Timeframe: 4 months post SCI

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: Baseline

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: 4 months post SCI

Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml

Timeframe: 1 year post SCI

Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.

Timeframe: Baseline, 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.