Health TrialsbyHealthPanel

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

ConditionNeurogenic Bladder Due to Spina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-17
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

chronic neurogenic bladder

Spina Bifida diagnosis

Use of overactive bladder medication(s)

Stable bladder medications for ≥ 3 months

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stamobil electric stimulator

    Device

    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.

  • sham tTNS device

    Device

    The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Stamobil electric stimulatorExperimental treatment 1 intervention
Group B: sham tTNS deviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety as assessed by the number of adverse events

Time frame
from start of trial to end of trial (4 weeks after start)
2

Feasibility as assessed by the satisfaction surveys

This is an 8 item questionnaire and each is scored from 1(strongly disagree) to 5(strongly agree) for a maximum score of 40, higher score indicating greater satisfaction .

Time frame
end of study (4 weeks after baseline)
3

Compliance of tTNS usage as assessed by the percent of sessions where toe flexion was elicited

This will be reported in the TTNS log

Time frame
from start of trial to end of trial (4 weeks after start)
4

Compliance of tTNS usage as assessed by the average current where toe flexion was elicited

This will be reported in the TTNS log

Time frame
from start of trial to end of trial (4 weeks after start)

Secondary outcomes

1

Percentage of participants that are able to reduce their overactive bladder (OAB) medications

Time frame
end of study (4 weeks after baseline)
2

percent dose reduction (mg ) achieved

Time frame
end of study (4 weeks after baseline)
3

Change in maximum detrusor pressure (Max Pdet (cmH20)) as assessed by the Urodynamic study (UDS)

Time frame
week 0, week 4
4

Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS)

Time frame
week 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov
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