At-home tibial nerve stimulation for children with spina bifida and neurogenic bladder
Official title: A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population
Run by The University of Texas Health Science Center, Houston · NCT07136688 · Data updated 2026-11-12
This trial will try daily home transcutaneous tibial nerve stimulation for children with spina bifida and neurogenic bladder to see if it's safe, practical, and helps bladder control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 4 Years to 17 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | April 11, 2027 |
| Study ends | August 11, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07136688 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children with spina bifida who have chronic neurogenic bladder, are taking stable overactive bladder medications for at least three months, can produce the required motor response to tibial nerve stimulation, and have an English-speaking caregiver able to complete training.
✕Probably not a fit
Patients with progressive spinal cord disease, known peripheral neuropathy or tibial nerve injury, significant unresolved lower-limb edema, prior confounding lower urinary tract surgery, inability to elicit a motor response, or caregivers who cannot complete the required English-language training are unlikely to benefit or to be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Children with spina bifida and chronic neurogenic bladder will be assigned to use either an active Stamobil transcutaneous tibial nerve stimulator or a sham device at home once daily for four weeks, with treatment delivered by the child or a caregiver after training. The study focuses on safety, feasibility, and adherence to a daily home protocol, and will collect measures of bladder symptoms and device compliance. Guardians must complete a proficiency checklist and be English-speaking to participate. The protocol excludes patients with progressive spinal cord disease, peripheral neuropathy affecting the tibial nerve pathway, or other lower urinary tract pathology that could confound results.
Why it matters
Potential benefit: If successful, this noninvasive home therapy could improve bladder control and reduce urinary symptoms or medication needs in some children with spina bifida.
How similar studies have gone: Tibial nerve stimulation (percutaneous and transcutaneous) has shown benefit for overactive bladder in adults and in small pediatric reports, but large, definitive pediatric randomized data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * chronic neurogenic bladder * Spina Bifida diagnosis * Use of overactive bladder medication(s) * Stable bladder medications for ≥ 3 months Exclusion Criteria: * Progressive SCI (ex: transverse myelitis, polio, etc.) * Other lower urinary tract pathology or surgery * 2+ pitting edema in the legs that does not resolve * Known peripheral neuropathy or injury to the path of the tibial nerve * Cancer in the tibial nerve pathway and/or lower urinary tract * Inability to elicit the motor response with electric stimulation * Inability to complete the tTNS proficiency checklist (guardians) * Non-English speaking (guardians)
Where it's running
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The University of Texas Health Science Center and Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Argyrios Stampas, MD, MS — The University of Texas Health Science Center and Houston
- Study coordinator: Argyrios Stampas, MD, MS
- Email: Argyrios.Stampas@uth.tmc.edu
- Phone: (713) 797-5007
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.