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Electric leg stimulation aims to preserve bladder function in spinal injury patients

NCT ID NCT04350359

Disease control Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study tests whether a non-invasive nerve stimulation on the leg, called transcutaneous tibial nerve stimulation (TTNS), can help maintain bladder function in people with recent spinal cord injury. Researchers will enroll 120 adults with spinal injuries at level T9 or above, starting treatment within 6 weeks of injury. The goal is to see if regular TTNS sessions can preserve bladder capacity and reduce bladder problems, potentially improving quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous tibial nerve stimulation (TTNS) device
What this could lead to
If it works, this could offer a non-invasive way to help people with spinal cord injury maintain bladder control and improve quality of life.
What could go wrong
This is an early-stage study with 120 participants, so results may not apply to everyone. The treatment may not work for all injury levels, and some people may find the stimulation uncomfortable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

111 people

The number who actually took part.

Started

Jun 2020

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

spinal cord injury Urinary Bladder, Neurogenic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal cord injuries

Contacts and locations

Locations

  • MedStar National Rehabilitation Hospital

    Washington D.C., District of Columbia, 20010, United States

  • TIRR Memorial Hermann Research Center

    Houston, Texas, 77030, United States

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