Status:
NOT_YET_RECRUITING
Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Neurogenic Bladder Due to Spina Bifida
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the safety, feasibility, and compliance of a daily home transcutaneous tibial nerve stimulation (tTNS) protocol in children with chronic neurogenic bladder (N...
Eligibility Criteria
Inclusion
- chronic neurogenic bladder
- Spina Bifida diagnosis
- Use of overactive bladder medication(s)
- Stable bladder medications for ≥ 3 months
Exclusion
- Progressive SCI (ex: transverse myelitis, polio, etc.)
- Other lower urinary tract pathology or surgery
- 2+ pitting edema in the legs that does not resolve
- Known peripheral neuropathy or injury to the path of the tibial nerve
- Cancer in the tibial nerve pathway and/or lower urinary tract
- Inability to elicit the motor response with electric stimulation
- Inability to complete the tTNS proficiency checklist (guardians)
- Non-English speaking (guardians)
Key Trial Info
Start Date :
August 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 11 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07136688
Start Date
August 18 2025
End Date
August 11 2027
Last Update
August 22 2025
Active Locations (1)
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1
The University of Texas Health Science Center and Houston
Houston, Texas, United States, 77030