Actively Recruiting
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
Led by University of Texas Southwestern Medical Center · Updated on 2026-02-12
12
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8-18 years
- Patient at Texas Scottish Rite Hospital (TSRH)
- Diagnosis of lumbosacral spina bifida (myelomeningocele, meningocele, lipoma of spinal cord, myelocystocele, diastematomyelia, fatty/thickened filum)
- Incontinence refractory to compliant catheterization
- Patient able and willing to undergo urodynamic testing without sedation
- No surgical reconstruction except a single appendicovesicostomy (APV)
- No Botox treatments within 1 year of enrollment
- Patient willing and able to stop bladder medications (anticholinergics or beta agonists) at least 2 weeks prior to pre-intervention assessments
- Patient lives close enough to TSRH and Children's Medical Center (CMC) for visits
- Patient and family speak English
You will not qualify if you...
- Age under 8 or over 18 years
- Diagnosis not listed in inclusion criteria
- Previous reconstructive surgeries except a single appendicovesicostomy (APV)
- Botox treatments within 1 year of enrollment
- Unable or unwilling to stop bladder medications (anticholinergics or beta agonists)
- High-risk bladder as assessed by treating provider
- Non-English speaking
- Pregnancy or suspected pregnancy
- Nursing patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Scottish Rite for Children
Dallas, Texas, United States, 75219
Actively Recruiting
Research Team
A
Alexandra Carolan, MD
CONTACT
S
Shreedhar Reddy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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