Neurogenic Bladder Due to Spina BifidaNCT07136688
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
A study testing Stamobil electric stimulator in people with Neurogenic Bladder Due to Spina Bifida, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Neurogenic Bladder Due to Spina Bifida
- What is being tested?
- Stamobil electric stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2026to 11 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- chronic neurogenic bladder
- Spina Bifida diagnosis
- Use of overactive bladder medication(s)
- Stable bladder medications for ≥ 3 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center and Houston
Houston, Texas, 77030
Argyrios Stampas, MD,MS, 713-797-5007, Argyrios.Stampas@uth.tmc.edu
Nancy Rosa, 713-797-5765, Nancy.Rosa@uth.tmc.edu
About this study
Official title: A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population
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
- Conditions
- Neurogenic Bladder Due to Spina Bifida
- Being tested
- Stamobil electric stimulator, sham tTNS device
- Keywords
- spinal cord injury (SCI), transcutaneous tibial nerve stimulation (tTNS)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Stamobil electric stimulator | Experimental | Not described Receives: Device: Stamobil electric stimulator |
| sham tTNS device | Sham comparator | Not described Receives: Device: sham tTNS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by the number of adverse events
Measured: 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 .
Measured: 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
Measured: 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
Measured: 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
Measured: 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 .
Measured: end of study (4 weeks after baseline)
Secondary outcomes (16)
Percentage of participants that are able to reduce their overactive bladder (OAB) medications
Measured: end of study (4 weeks after baseline)
percent dose reduction (mg ) achieved
Measured: end of study (4 weeks after baseline)
Change in maximum detrusor pressure (Max Pdet (cmH20)) as assessed by the Urodynamic study (UDS)
Measured: week 0, week 4
Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS)
Measured: week 0
Presence of Detrusor overactivity (DO) as assessed by the Urodynamic study (UDS)
Measured: Week 4
Change in maximum volume (mL) that bladder can hold before voiding or discomfort as assessed by the Urodynamic study (UDS)
Measured: Week 0, Week 4
Presence of bladder leak as assessed by the Urodynamic study (UDS)
Measured: Week 0
Presence of bladder leak as assessed by the Urodynamic study (UDS)
Measured: 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
Measured: 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.
Measured: Week 0, Week 4
Number of incontinence episodes as reported in the voiding diary
Measured: from start of trial to end of trial (4 weeks after start)
Frequency of catheterization as reported in the voiding diary
Measured: from start of trial to end of trial (4 weeks after start)
Volumes of catheterization as reported in the voiding diary
Measured: 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
Measured: 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
Measured: 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.
Measured: Week 0, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start27 Mar 2026
- Primary completion11 Apr 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Bladder Due to Spina BifidaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
- Investigators
- Argyrios Stampas, MD, MS, Principal investigator, The University of Texas Health Science Center and Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136688
- Sponsor's protocol ID
- HSC-MS- 24-1198
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Transcutaneous Tibial Nerve Stimulation for Neurogenic Bladder in the Pediatric Population
- ClinicalTrials.gov ID
- NCT07136688
- Acronym / sponsor ID
- HSC-MS- 24-1198
- Conditions
- Neurogenic Bladder Due to Spina Bifida
- Keywords
- spinal cord injury (SCI), transcutaneous tibial nerve stimulation (tTNS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 11 Apr 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stamobil electric stimulator | Experimental | Device: Stamobil electric stimulator |
| sham tTNS device | Sham comparator | Device: sham tTNS device |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- chronic neurogenic bladder
- Spina Bifida diagnosis
- Use of overactive bladder medication(s)
- Stable bladder medications for ≥ 3 months
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stamobil electric stimulatorThe 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 | Stamobil electric stimulator |
| sham tTNS deviceThe electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week | Device | sham tTNS device |
Primary outcome
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 .
16 secondary outcomes
Percentage of participants that are able to reduce their overactive bladder (OAB) medications
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)
Time frame: Week 0, Week 4
Change in detrusor compliance as assessed by the Urodynamic study (UDS)
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)
Time frame: Week 0, Week 4
Change in bowel function as assessed by the Neurogenic Bowel Dysfunction Score (NBDS)
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
Time frame: Week 0, Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder Due to Spina Bifida
Recruiting
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENT THERAPY IN CHILDREN WITH SPINAL DYSRAPHISM.
Neurogenic Bladder Due to Spinal Dysraphism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Argyrios Stampas, MD, MS principal investigator
The University of Texas Health Science Center and Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stamobil electric stimulator in people with Neurogenic Bladder Due to Spina Bifida, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argyrios Stampas, MD, MS ((713) 797-5007, Argyrios.Stampas@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by the number of adverse events (time frame: from start of trial to end of trial (4 weeks after start)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.