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Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

This study is looking at a treatment called transcutaneous tibial nerve stimulation (tTNS) for children with neurogenic bladder (bladder problems due to nerve damage) caused by spina bifida. The study will test a device called the Stamobil electric stimulator, which delivers mild electrical pulses to the ankle. It will also compare this to a sham device (a device that looks real but delivers very low stimulation). The main goals are to see if the treatment is safe, if families can easily use it at home, and if children will use it regularly. The study aims to enroll 20 children between 4 and 17 years old who have chronic neurogenic bladder due to spina bifida and are already taking medication for an overactive bladder. The study's status is currently unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
You would use the tTNS device or a sham device at home for 30 minutes daily, 5 days a week, for a total of 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
Safety, feasibility, and compliance will be measured from the start of the trial until 4 weeks after the start.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07136688

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

Recruiting
NAAges 4–17InterventionalTreatment
The University of Texas Health Science Center, Houston
~20 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Stamobil electric stimulatorsham tTNS device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as assessed by the number of adverse events
Measured over from start of trial to end of trial (4 weeks after start)
+5 more outcomes measured

Conditions

Neurogenic Bladder Due to Spina Bifida

Explore related trials

Neurogenic BladderSpina BifidaSpinal Cord Injury

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Argyrios Stampas, MD, MS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center and Houston

Who to contact

Argyrios Stampas, MD, MS
[email protected]
(713) 797-5007
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Safety as assessed by the number of adverse eventsfrom start of trial to end of trial (4 weeks after start)
  • Feasibility as assessed by the satisfaction surveysend of study (4 weeks after baseline)

    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 .

  • Compliance of tTNS usage as assessed by the percent of sessions where toe flexion was elicitedfrom start of trial to end of trial (4 weeks after start)

    This will be reported in the TTNS log

  • Compliance of tTNS usage as assessed by the average current where toe flexion was elicitedfrom start of trial to end of trial (4 weeks after start)

    This will be reported in the TTNS log

  • Compliance of tTNS usage as assessed by percentage of sessions that bladder medications were takenfrom start of trial to end of trial (4 weeks after start)

    This will be reported in the TTNS log

  • Satisfaction as assessed by the surveyend of study (4 weeks after baseline)

    This will measure the likelihood of tTNS preference over anticholinergic medication use 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 .