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

Recruiting now · Not applicable

Conditions studied: Spina Bifida

In brief

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.

Key facts

Study ID

NCT06025734

Run by

University of Texas Southwestern Medical Center

People needed

12

Starts

2025-11-18

Expected to finish

2028-12-01

Last updated by the study team

2026-02-12

Who can join

Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scottish Rite for Children — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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