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 range4 Years – 17 Years

SexALL

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)

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 range4 Years – 17 Years

SexALL

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)