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NCT Number: NCT07136688

Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

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

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Key information

Conditions

Neurogenic Bladder Due to Spina Bifida Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

    Time frame: end 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 .

  3. 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)

    This will be reported in the TTNS log

  4. 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)

    This will be reported in the TTNS log

  5. 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)

    This will be reported in the TTNS log

  6. Satisfaction as assessed by the survey

    Time frame: end 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 .

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

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

    Time frame: Week 4

  6. 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

  7. Presence of bladder leak as assessed by the Urodynamic study (UDS)

    Time frame: Week 0

  8. Presence of bladder leak as assessed by the Urodynamic study (UDS)

    Time frame: Week 4

  9. Change in bladder sensation as assessed by the Urodynamic study (UDS)

    Time frame: Week 0, Week 4

    volume infused (mL) at 1) time of reported first sensation of filling, 2) time of reported urgency/desire to void, & 3) time of reported discomfort

  10. Change in detrusor compliance as assessed by the Urodynamic study (UDS)

    Time frame: Week 0, Week 4

    reported as change in bladder volume divided by change in bladder pressure.

  11. Number of incontinence episodes as reported in the voiding diary

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

  12. Frequency of catheterization as reported in the voiding diary

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

  13. Volumes of catheterization as reported in the voiding diary

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

  14. Change in bladder symptoms as assessed by the Neurogenic Bladder Symptom Score (NBSS)

    Time frame: Week 0, Week 4

    This is a 24 item questionnaire that is scored from 0 (no symptoms) to 4 (worst symptoms), maximum score of 96 with higher values indicating greater symptom burden

  15. Change in bowel function as assessed by the Neurogenic Bowel Dysfunction Score (NBDS)

    Time frame: Week 0, Week 4

    This is a 10 item questionnaire that is scored from 0 (very minor ) to greater than or equal to 14(severe), maximum score range of 0-47 with higher scores indicating worse outcome

  16. Change in general physical and mental health status as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire for Global Health

    Time frame: Week 0, Week 4

    This is a 10 item questionnaire. The measure yields two standardized summary scores: Global Physical Health (GPH) and Global Mental Health (GMH).Each summary score is calculated based on 4 items from the questionnaire and is converted to a T-score using the PROMIS scoring manual. T-scores have a mean of 50 and standard deviation of 10, based on the U.S. general population. Higher T-scores indicate better health.

Study contacts

Contact information is provided by the study sponsor or research team.

Argyrios Stampas, MD, MS

CONTACT

[email protected]

(713) 797-5007

Jaqueline Martinez

CONTACT

[email protected]

713-797-5765

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 22, 2025
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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