Status:
RECRUITING
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Spina Bifida
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief 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 spi...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06025734
Start Date
November 18 2025
End Date
May 1 2026
Last Update
December 31 2025
Active Locations (1)
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1
Scottish Rite for Children
Dallas, Texas, United States, 75219