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Ankle zaps may curb bladder leaks in kids with spina bifida

NCT ID NCT06025734

Symptom relief Sponsor: University of Texas Southwestern Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment called transcutaneous tibial nerve stimulation (TTNS) for children aged 8-18 with spina bifida who still leak urine despite regular catheter use. TTNS uses mild electrical pulses at the ankle to stimulate a nerve that helps control the bladder. Participants will receive 6 weekly treatments (done at home after the first session) and track leakage episodes, pad use, and quality of life. If it works, treatment may continue for another 6 weeks.

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

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

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

8 to 18 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: * Age 8-18 * Patient at TSRH * Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum) * Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider) * Patient able and willing to undergo urodynamic testing without sedation * No surgical reconstruction with the exception of a single appendicovesicostomy (APV) * No Botox treatments within 1 year of enrollment * Patient willing and able to stop bladder medications (anticholinergics or beta agonists) 2 weeks prior to pre-intervention bladder diary, questionnaires and UDS * Patient lives close enough to TSRH and CMC to be willing to return for UDS, teaching, and clinic visits as detailed above * Patient/family speak English Exclusion Criteria: * Ages \<8 or \>18 * Diagnosis not listed above * Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV * Patient received Botox treatment within 1 year of enrollment * Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists) * Patients with high-risk bladders, as assessed by their treating provider (i.e. poorly compliant bladders with high end-fill pressures) * Non-English speaking * Patients who are pregnant * Patients who are suspected of being pregnant * Patients who are nursing

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Conditions

The condition(s) this trial relates to.

spina bifida Urinary Bladder, Neurogenic

As listed by the trial registrant

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

Spina bifida

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Scottish Rite for Children

    RECRUITING

    Dallas, Texas, 75219, United States

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