NCT07136688 · The University of Texas Health Science Center, Houston
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
What this study is about
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 effectiveness of tTNS
View original scientific description
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
Interventions
DEVICE
Stamobil electric stimulator
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.
DEVICE
sham tTNS device
The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week
Primary outcome measures
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
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 .
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
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
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
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 .
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations