A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population
The University of Texas Health Science Center, Houston
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
- Age range
- 4–17 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceStamobil electric stimulator
The electric stimulation protocol will use stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode for 30 minutes daily. The goal is daily use of tTNS for 4 weeks , 5 days per week.
- Devicesham tTNS device
The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week
Location
- The University of Texas Health Science Center and HoustonHouston, Texas