Spina BifidaNCT06025734
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
A study testing Transcutaneous Tibial Nerve Stimulation (TTNS) treatment in people with Spina Bifida, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effectiveness of a treatment called "transcutaneous tibial nerve stimulation" or "TTNS" in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Spina Bifida
- What is being tested?
- Transcutaneous Tibial Nerve Stimulation (TTNS) treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2025to Dec 2028
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 8-18
- Patient at TSRH
- Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum)
- Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider)
- Patient able and willing to undergo urodynamic testing without sedation
- No surgical reconstruction with the exception of a single appendicovesicostomy (APV)
Show all 10Show fewer
- No Botox treatments within 1 year of enrollment
- Patient willing and able to stop bladder medications (anticholinergics or beta agonists) 2 weeks prior to pre-intervention bladder diary, questionnaires and UDS
- Patient lives close enough to TSRH and CMC to be willing to return for UDS, teaching, and clinic visits as detailed above
- Patient/family speak English
Who cannot join
- Ages <8 or >18
- Diagnosis not listed above
- Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV
- Patient received Botox treatment within 1 year of enrollment
- Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists)
- Patients with high-risk bladders, as assessed by their treating provider (i.e. poorly compliant bladders with high end-fill pressures)
Show all 10Show fewer
- Non-English speaking
- Patients who are pregnant
- Patients who are suspected of being pregnant
- Patients who are nursing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shreedhar Reddy contact
United States1 site, 1 recruiting
- Recruiting
Scottish Rite for Children
Dallas, Texas, 75219
About this study
Official title: Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida
The purpose of this research study is to determine the effectiveness of a treatment called "transcutaneous tibial nerve stimulation" or "TTNS" in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Participants will complete urodynamic testing and questionnaires prior to the treatments. Participants will then complete 6 weekly treatments of TTNS. Participants will learn how to do the treatment in the clinic, and then can complete the treatments at home. For patients with a good response, the treatments may be continued for another 6 weeks, for a total of 6 weeks.
Read the detailed description
This study is designed to determine the outcomes of spina bifida patients with neurogenic bladder who receive Transcutaneous Tibial Nerve Stimulation (TTNS) treatment.
To identify patients that may receive the most benefit from TTNS treatment.
Patients with neurogenic bladder secondary to spina bifida with low-risk bladders, who are compliant with catheterizing, will see decreased urinary leakage and improved urodynamic parameters when used in combination with TTNS treatment.
Posterior tibial nerve stimulation via percutaneous (PTNS) or transcutaneous (TTNS) approaches have been effective in treating urinary incontinence from overactive bladder (OAB) and voiding dysfunction in adults. While the exact mechanism of action remains under evaluation, it is a standard of care for adults with OAB refractory to behavioral modifications. Studies have shown PTNS to be effective in children with overactive bladder disease and urinary retention secondary to non-neurogenic causes. TTNS has been shown to be effective for OAB symptoms in children compared to sham intervention, and further studies are ongoing. Moreover, it has been demonstrated that TTNS is non-inferior to PTNS in treating OAB in adults. TTNS is appealing due to its less invasive nature compared to PTNS.
Posterior tibial nerve stimulation implementation in the pediatric population is increasing. To date, few studies have evaluated the efficacy of posterior tibial nerve stimulation in children with spina bifida as some believe the spinal dysraphism may disrupt the mechanism of the technique. However, another form of neuromodulation, surgically-implanted sacral neuromodulation (Interstim), has been shown to be effective for urinary and bowel parameters for some patients with neurogenic bladder secondary to spina bifida. The hypothesis in the proposed study is that TTNS may benefit a subset of patients with less severe spina bifida and may be a treatment option in managing their refractory urinary incontinence.
Pre-intervention
If patient is on bladder medication(s) (anticholinergics or beta agonists), they will stop the bladder medication 2-4 weeks (minimum of 2 weeks) before pre-intervention urodynamic study (UDS)
Patient will complete 3 Day Bladder Diary at home prior to intervention (must be done at least 2 weeks after stopping bladder medications)
Patients will be provided scales for measuring diaper/pad weights at home.
At least 2 weeks after stopping bladder medications (if applicable), patient completes UDS (standard, not video) at Children's Medical Center (CMC)
At this visit, patient completes pre-intervention questionnaires (detailed below in Section 7)
Intervention Period
Intervention overview: Patients will complete weekly 30-minute sessions of TTNS. Intervention procedure described below.
The intervention period will start as 6 weeks for all patients, with extension to 12 weeks for patients who meet any of the measures of success as defined below in the "Post-intervention" section
After patient has completed pre-intervention 3 Day Bladder Diary, UDS and questionnaires, they will proceed with TTNS nursing teaching visit and the first TTNS session at Texas Scottish Rite Hospital (TSRH) or Children's Medical Center Dallas (therefore, if they have completed the Bladder Diary prior to their UDS appointment, the TTNS nursing teaching visit can be completed the same day as their UDS appointment)
At the teaching visit, patient/parent will be shown how to perform the TTNS treatment. They will then demonstrate the process of placing the electrodes and starting the treatment. The first 30-minute session will then be done at this visit. If understanding of process is demonstrated, further treatments will be done at home. If not, they will return the following week for further teaching and the second treatment. Nursing visits will be continued until proficiency is demonstrated by the patient/family, as assessed by the nurse conducting the visit.
The patient will be contacted by phone by the research team weekly after their nursing visit when proficiency was demonstrated, in order to answer questions and monitor compliance. Patients will return for additional teaching sessions as needed.
- Conditions
- Spina Bifida
- Being tested
- Transcutaneous Tibial Nerve Stimulation (TTNS) treatment
- Keywords
- Pediatrics, Neurogenic bladder, TTNS
- Medical subject headings
- Spinal Dysraphism, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Tibial Nerve Stimulation (TTNS) treatmentDevice
Spina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session)
| Study group | Role | What they receive |
|---|---|---|
| TTNS Treatment Arm | Experimental | Treatments Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) During treatments, patient may experience a tingling sensation in the foot/ankle. Patient may have discomfort in the area when first adjusting to the correct amount of stimulation for patient.
Patient will have a visit with your doctor after 6 weeks of treatment at Scottish Rite. If patient have a good response to the treatments, they may be extended for another 6 weeks.
After treatments Bladder diary (completed at home, on paper over a 3-day period, recording catheterization volumes and amount of leakage by weighing pads/diapers) Complete questionnaires on paper (about 10 minutes) Complete urodynamic testing at Children's Medical Center (approximately 45-60 minutes). Receives: Device: Transcutaneous Tibial Nerve Stimulation (TTNS) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of leakage episodes
Number of leakage episodes will be measured by 3 Day Bladder Diary
Measured: 12 weeks
Secondary outcomes (5)
Leak weight
Leak weight of the diapers will be measured by wet-diaper weight in grams
Measured: 12 weeks
Number of pads used
Number of pads used will be measured using 3-day bladder diary
Measured: 12 weeks
Number of diapers used
Number of diapers used will be measured using 3-day bladder diary
Measured: 12 weeks
Quality of Life Assessment in Spina Bifida Score
Quality of life (QoL) is measured by QUALAS assessment tool. QUALAS stands for Quality of Life Assessment of spina bifida. There are separate (but largely similar) versions for adults (QUALAS-A), children aged 8-12 (QUALAS-C) and teenagers (QUALAS-T). Each of these have further "domains" (that are scored from 0-100) that are aggregated to report quality of life scores (see below): 2 domains each for QUALAS C and T, and 3 domains for QUALAS-A. Lower scores in C and T indicate better QoL. But in QUALAS A it is mixed (Domain 1 -'Health and Relationships' : Higher scores indicate better QoL; Domain 2- 'Esteem and Sexuality' : Lower scores indicate better QoL ; Domain 3- 'Bowel and Bladder' : Lower scores indicate better QoL)
Measured: 12 weeks
Self assessment of improvement
Improvement will be measured quantitatively in 1-5 range where 1 reflects strong disagreement and 5 strong agreement
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start18 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Adams, University of Texas Southwestern Medical Center
- Investigators
- Richard Adams, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025734
- Sponsor's protocol ID
- STU-2023-0178
- Status last verified
- Feb 2026
- First submitted
- 22 Aug 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Tibial Nerve Stimulation in Pediatric Patients With Neurogenic Bladder Secondary to Spina Bifida
- ClinicalTrials.gov ID
- NCT06025734
- Acronym / sponsor ID
- STU-2023-0178
- Conditions
- Spina Bifida
- Keywords
- Pediatrics, Neurogenic bladder, TTNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Sep 2023 (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 research study is to determine the effectiveness of a treatment called "transcutaneous tibial nerve stimulation" or "TTNS" in the treatment of urinary leakage for patients with spina bifida. This treatment involves electrical stimulation of a nerve by the ankle. Participants will complete urodynamic testing and questionnaires prior to the treatments. Participants will then complete 6 weekly treatments of TTNS. Participants will learn how to do the treatment in the clinic, and then can complete the treatments at home. For patients with a good response, the treatments may be continued for another 6 weeks, for a total of 6 weeks.
Detailed description
This study is designed to determine the outcomes of spina bifida patients with neurogenic bladder who receive Transcutaneous Tibial Nerve Stimulation (TTNS) treatment.
To identify patients that may receive the most benefit from TTNS treatment.
Patients with neurogenic bladder secondary to spina bifida with low-risk bladders, who are compliant with catheterizing, will see decreased urinary leakage and improved urodynamic parameters when used in combination with TTNS treatment.
Posterior tibial nerve stimulation via percutaneous (PTNS) or transcutaneous (TTNS) approaches have been effective in treating urinary incontinence from overactive bladder (OAB) and voiding dysfunction in adults. While the exact mechanism of action remains under evaluation, it is a standard of care for adults with OAB refractory to behavioral modifications. Studies have shown PTNS to be effective in children with overactive bladder disease and urinary retention secondary to non-neurogenic causes. TTNS has been shown to be effective for OAB symptoms in children compared to sham intervention, and further studies are ongoing. Moreover, it has been demonstrated that TTNS is non-inferior to PTNS in treating OAB in adults. TTNS is appealing due to its less invasive nature compared to PTNS.
Posterior tibial nerve stimulation implementation in the pediatric population is increasing. To date, few studies have evaluated the efficacy of posterior tibial nerve stimulation in children with spina bifida as some believe the spinal dysraphism may disrupt the mechanism of the technique. However, another form of neuromodulation, surgically-implanted sacral neuromodulation (Interstim), has been shown to be effective for urinary and bowel parameters for some patients with neurogenic bladder secondary to spina bifida. The hypothesis in the proposed study is that TTNS may benefit a subset of patients with less severe spina bifida and may be a treatment option in managing their refractory urinary incontinence.
Pre-intervention
If patient is on bladder medication(s) (anticholinergics or beta agonists), they will stop the bladder medication 2-4 weeks (minimum of 2 weeks) before pre-intervention urodynamic study (UDS)
Patient will complete 3 Day Bladder Diary at home prior to intervention (must be done at least 2 weeks after stopping bladder medications)
Patients will be provided scales for measuring diaper/pad weights at home.
At least 2 weeks after stopping bladder medications (if applicable), patient completes UDS (standard, not video) at Children's Medical Center (CMC)
At this visit, patient completes pre-intervention questionnaires (detailed below in Section 7)
Intervention Period
Intervention overview: Patients will complete weekly 30-minute sessions of TTNS. Intervention procedure described below.
The intervention period will start as 6 weeks for all patients, with extension to 12 weeks for patients who meet any of the measures of success as defined below in the "Post-intervention" section
After patient has completed pre-intervention 3 Day Bladder Diary, UDS and questionnaires, they will proceed with TTNS nursing teaching visit and the first TTNS session at Texas Scottish Rite Hospital (TSRH) or Children's Medical Center Dallas (therefore, if they have completed the Bladder Diary prior to their UDS appointment, the TTNS nursing teaching visit can be completed the same day as their UDS appointment)
At the teaching visit, patient/parent will be shown how to perform the TTNS treatment. They will then demonstrate the process of placing the electrodes and starting the treatment. The first 30-minute session will then be done at this visit. If understanding of process is demonstrated, further treatments will be done at home. If not, they will return the following week for further teaching and the second treatment. Nursing visits will be continued until proficiency is demonstrated by the patient/family, as assessed by the nurse conducting the visit.
The patient will be contacted by phone by the research team weekly after their nursing visit when proficiency was demonstrated, in order to answer questions and monitor compliance. Patients will return for additional teaching sessions as needed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTNS Treatment Arm | Experimental | Device: Transcutaneous Tibial Nerve Stimulation (TTNS) treatmentTreatments Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) During treatments, patient may experience a tingling sensation in the foot/ankle. Patient may have discomfort in the area when first adjusting to the correct amount of stimulation for patient. Patient will have a visit with your doctor after 6 weeks of treatment at Scottish Rite. If patient have a good response to the treatments, they may be extended for another 6 weeks. After treatments Bladder diary (completed at home, on paper over a 3-day period, recording catheterization volumes and amount of leakage by weighing pads/diapers) Complete questionnaires on paper (about 10 minutes) Complete urodynamic testing at Children's Medical Center (approximately 45-60 minutes). |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age 8-18
- Patient at TSRH
- Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum)
- Incontinence refractory to compliant catheterization (compliance with catheterization as assessed by their treating provider)
- Patient able and willing to undergo urodynamic testing without sedation
Key exclusion criteria (10 listed)
- Ages <8 or >18
- Diagnosis not listed above
- Patients that have received reconstructive surgeries (i.e. augmentation or bladder neck sling) with the exception for a single APV
- Patient received Botox treatment within 1 year of enrollment
- Patient unable or unwilling to stop bladder medications (anticholinergics or beta agonists)
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 |
|---|---|---|
| Transcutaneous Tibial Nerve Stimulation (TTNS) treatmentSpina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) | Device | TTNS Treatment Arm |
Primary outcome
Number of leakage episodes
Time frame: 12 weeks
Number of leakage episodes will be measured by 3 Day Bladder Diary
5 secondary outcomes
Leak weight
Time frame: 12 weeks
Number of pads used
Time frame: 12 weeks
Number of diapers used
Time frame: 12 weeks
Quality of Life Assessment in Spina Bifida Score
Time frame: 12 weeks
Self assessment of improvement
Time frame: 12 weeks
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 12 Feb 2026.
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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.
Shreedhar Reddy contact
Richard Adams, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Tibial Nerve Stimulation (TTNS) treatment in people with Spina Bifida, run by University of Texas Southwestern Medical Center 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 10 inclusion and 10 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 12 Feb 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. 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 Alexandra Carolan, MD (214-456-5632, alexandra.carlon@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of leakage episodes (time frame: 12 weeks). 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 12 Feb 2026.