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Transcutaneous Tibial Nerve Stimulation (TTNS) for Spina Bifida with Neurogenic Bladder

This study is looking at how well a treatment called Transcutaneous Tibial Nerve Stimulation (TTNS) helps children with spina bifida who experience urinary leakage due to neurogenic bladder (a bladder problem caused by nerve damage). TTNS involves gentle electrical stimulation of a nerve near the ankle. The study aims to see if this treatment can reduce how often children leak urine. You might be able to join if you are 8 to 18 years old, have spina bifida, and are already receiving care at TSRH. The study plans to enroll 12 participants. The study's current status is unclear, meaning it's not actively recruiting or has not yet started.

Study design
This is an interventional study with a planned enrollment of 12 participants, focusing on the effects of TTNS treatment.
What's involved
You would complete urodynamic testing and questionnaires, then have 6 weekly 30-minute TTNS treatment sessions, with the option for another 6 weeks if helpful. Most treatments can be done at home after an initial teaching session.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, number of leakage episodes, will be measured at 12 weeks after starting treatment.

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NCT06025734

Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder

Recruiting
NAAges 8–18Interventional
University of Texas Southwestern Medical Center
~12 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Transcutaneous Tibial Nerve Stimulation (TTNS) treatment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of leakage episodes
Measured over 12 weeks

Conditions

Spina Bifida

Explore related trials

Neurogenic BladderSpina Bifida

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Richard Adams, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Alexandra Carolan, MD
[email protected]
214-456-5632
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of leakage episodes12 weeks

    Number of leakage episodes will be measured by 3 Day Bladder Diary