At-home tibial nerve stimulation for children with spina bifida and neurogenic bladder
A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07136688 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Houston, Texas
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.