Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
Eligible age
8–18 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this 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.
Sponsor: University of Texas Southwestern Medical Center
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
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
Where it's recruiting
Dallas
Source: ClinicalTrials.gov · NCT06025734 · last updated 2026-02-12