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New treatment option for Spina Bifida
Official title Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
ClinicalTrials.gov ID: NCT06025734
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- 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
You likely can't join if
- Ages \ 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)
See the full eligibility 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
- Ages \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.