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

Recruiting

Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida

Who can join

Ages 8 to 18 · All sexes

Full eligibility criteria
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

About the study

The purpose of this research study is to determine the effectiveness of a treatment called "transcutaneous tibial nerve stimulation" or "TTNS" in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Participants will complete urodynamic testing and questionnaires prior to the treatments. Participants will then complete 6 weekly treatments of TTNS. Participants will learn how to do the treatment in the clinic, and then can complete the treatments at home. For patients with a good response, the treatments may be continued for another 6 weeks, for a total of 6 weeks.

What is being tested

Sponsor: University of Texas Southwestern Medical Center · Participants: 12 · Started: Nov 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06025734

Locations in the U.S.

TexasScottish Rite for Children, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.