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Recruiting NCT07136688

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

No phase Interventional Neurogenic Bladder Due to Spina Bifida

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stamobil electric stimulator, sham tTNS device.
Who it may be relevant to
Registry conditions: Neurogenic Bladder Due to Spina Bifida. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Device Stamobil 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.
  • Device sham tTNS device
    The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

Primary outcome measures

  • Safety as assessed by the number of adverse events [Time frame: from start of trial to end of trial (4 weeks after start)]
  • Feasibility as assessed by the satisfaction surveys [Time frame: end of study (4 weeks after baseline)]
  • Compliance of tTNS usage as assessed by the percent of sessions where toe flexion was elicited [Time frame: from start of trial to end of trial (4 weeks after start)]
  • Compliance of tTNS usage as assessed by the average current where toe flexion was elicited [Time frame: from start of trial to end of trial (4 weeks after start)]
  • Compliance of tTNS usage as assessed by percentage of sessions that bladder medications were taken [Time frame: from start of trial to end of trial (4 weeks after start)]
  • Satisfaction as assessed by the survey [Time frame: end of study (4 weeks after baseline)]
Secondary outcome measures (12)
  • Percentage of participants that are able to reduce their overactive bladder (OAB) medications [Time frame: end of study (4 weeks after baseline)]
  • percent dose reduction (mg ) achieved [Time frame: end of study (4 weeks after baseline)]
  • Change in maximum detrusor pressure (Max Pdet (cmH20)) as assessed by the Urodynamic study (UDS) [Time frame: week 0, week 4]
  • Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS) [Time frame: week 0]
  • Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS) [Time frame: Week 4]
  • Change in maximum volume (mL) that bladder can hold before voiding or discomfort as assessed by the Urodynamic study (UDS) [Time frame: Week 0, Week 4]
  • Presence of bladder leak as assessed by the Urodynamic study (UDS) [Time frame: Week 0]
  • Presence of bladder leak as assessed by the Urodynamic study (UDS) [Time frame: Week 4]
  • Change in bladder sensation as assessed by the Urodynamic study (UDS) [Time frame: Week 0, Week 4]
  • Change in detrusor compliance as assessed by the Urodynamic study (UDS) [Time frame: Week 0, Week 4]
  • Number of incontinence episodes as reported in the voiding diary [Time frame: from start of trial to end of trial (4 weeks after start)]
  • Frequency of catheterization as reported in the voiding diary [Time frame: from start of trial to end of trial (4 weeks after start)]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center and Houston — Houston

Identifiers

NCT: NCT07136688 · HSC-MS- 24-1198

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗