NCT07136688NARecruiting
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
The University of Texas Health Science Center, Houston
Start Date
3/27/2026
Completion Date
8/11/2027
Summary
The purpose of this study is to determine the safety, feasibility, and compliance of a daily home transcutaneous tibial nerve stimulation (tTNS) protocol in children with chronic neurogenic bladder (NB) provided by self or caregiver for 4 weeks and to estimate the efficacy of tTNS
Eligibility Criteria
Age Range: 4 years to 17 years
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)
Interventions
DEVICE
Stamobil electric stimulator
DEVICE
sham tTNS device
Conditions
Neurogenic Bladder Due to Spina Bifida
Locations
The University of Texas Health Science Center and Houston
Houston, Texas 77030
United States