RecruitingNot ApplicableNCT07136688

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

20 participants

Start Date

Mar 27, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 4 YearsMax Age: 17 Years

Inclusion Criteria4

  • chronic neurogenic bladder
  • Spina Bifida diagnosis
  • Use of overactive bladder medication(s)
  • Stable bladder medications for ≥ 3 months

Exclusion Criteria8

  • Progressive SCI (ex: transverse myelitis, polio, etc.)
  • Other lower urinary tract pathology or surgery
  • + 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)

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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


Locations(1)

The University of Texas Health Science Center and Houston

Houston, Texas, United States

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NCT07136688