RecruitingNot ApplicableNCT06025734

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

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

Sponsor

University of Texas Southwestern Medical Center

Enrollment

12 participants

Start Date

Nov 18, 2025

Study Type

INTERVENTIONAL

Conditions

Spina Bifida

Summary

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.

Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria10

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 Criteria10

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscutaneous Tibial Nerve Stimulation (TTNS) treatment

Spina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session)