Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

N/ANot Yet RecruitingNCT07136688

The University of Texas Health Science Center, Houston20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neurogenic Bladder Due to Spina Bifida

Interventions

Stamobil electric stimulatorDEVICE

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 deviceDEVICE

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

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Texas Health Science Center and Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Safety as assessed by the number of adverse events

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

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)

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)

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)

Compliance of tTNS usage as assessed by percentage of sessions that bladder medications were taken

This will be reported in the TTNS log

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

Satisfaction as assessed by the survey

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 .

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

Secondary Outcomes

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

Central Contacts

Argyrios Stampas, MD, MS

CONTACT

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

Jaqueline Martinez

CONTACT

713-797-5765 Jacqueline.B.Martinez@uth.tmc.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

percent dose reduction (mg ) achieved

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

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

Time frame: week 0, week 4

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

Time frame: week 0

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

Time frame: Week 4

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

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

Time frame: Week 0

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

Time frame: Week 4

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

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

Time frame: Week 0, Week 4

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

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

Time frame: Week 0, Week 4

Number of incontinence episodes as reported in the voiding diary

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

Frequency of catheterization as reported in the voiding diary

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

Volumes of catheterization as reported in the voiding diary

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

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

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

Time frame: Week 0, Week 4

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

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

Time frame: Week 0, Week 4

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

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.

Time frame: Week 0, Week 4