RecruitingNot Applicable

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

United States20 participantsStarted 2026-03-27

Plain-language 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

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as assessed by the number of adverse events

Timeframe: from start of trial to end of trial (4 weeks after start)

Feasibility as assessed by the satisfaction surveys

Timeframe: end of study (4 weeks after baseline)

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

Timeframe: 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

Timeframe: 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

Timeframe: from start of trial to end of trial (4 weeks after start)

Satisfaction as assessed by the survey

Timeframe: end of study (4 weeks after baseline)

Trial details

NCT IDNCT07136688

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-11

Contact for this trial

Argyrios Stampas, MD, MS

(713) 797-5007 Argyrios.Stampas@uth.tmc.edu

View on ClinicalTrials.gov More Neurogenic Bladder Due to Spina Bifida trials

Who can participate

Age range

4 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety as assessed by the number of adverse events

Timeframe: from start of trial to end of trial (4 weeks after start)

Feasibility as assessed by the satisfaction surveys

Timeframe: end of study (4 weeks after baseline)

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

Timeframe: 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

Timeframe: 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

Timeframe: from start of trial to end of trial (4 weeks after start)

Satisfaction as assessed by the survey

Timeframe: end of study (4 weeks after baseline)