Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Neurogenic Bladder Due to Spina Bifida

Treatments: Device: Stamobil electric stimulator; Device: sham tTNS device

Study type: Interventional

Funder types: Other

Identifiers

NCT07136688

HSC-MS- 24-1198

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Stamobil electric stimulator

Experimental group

Treatment:

Device: Stamobil electric stimulator

sham tTNS device

Sham Comparator group

Treatment:

Device: sham tTNS device