TTNS Treatment for Urinary Leakage in Spina Bifida
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
Recruiting
N/AInterventional Study
Spina Bifida
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
8 – 18
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
12 (estimated)
Sponsor
University of Texas Southwestern Medical Center · Other
Who this trial is looking for
This trial is looking for young patients with spina bifida who experience urinary leakage. Participants will receive a treatment called transcutaneous tibial nerve stimulation (TTNS) and complete tests and surveys to help evaluate the treatment's effectiveness.
Are You a Good Fit for This Trial?
Must not be takingAnticholinergicsBeta agonists
You may be able to join if
I am aged between 8 and 18 years old
I have been diagnosed with lumbosacral spina bifida
I have urinary leakage that has not improved with catheterization
I can and will undergo urodynamic testing without sedation
I have not had surgical reconstruction except for a single appendicovesicostomy
I can stop taking bladder medications 2 weeks before the study starts
I live close enough to return for visits and testing
My family and I speak English
You may not be able to join if
I am younger than 8 or older than 18 years old
I have a different diagnosis than those listed
I have had reconstructive surgeries except for a single appendicovesicostomy
I received Botox treatment in the last year
I cannot stop taking bladder medications
I have a high-risk bladder condition
I do not speak English
I am pregnant or nursing
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 comp…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 assesse…
Inclusion Criteria:
* 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)
* 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
Exclusion Criteria:
* 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)
* Non-English speaking
* Patients who are pregnant
* Patients who are suspected of being pregnant
* Patients who are nursing
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