Tibial Nerve Stimulation for Pediatric Spina Bifida Neurogenic Bladder

Conditions

• Neurogenic Bladder Due to Spina Bifida

Eligibility Criteria

Sex

ALL

Age

4 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Stamobil electric stimulator — DEVICE
  The electric stimulation protocol will use stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode for 30 minutes daily. The goal is daily use of tTNS for 4 weeks , 5 days per week.
• sham tTNS device — DEVICE
  The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

Study Details

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 (NB) provided by self or caregiver for 4 weeks and to estimate the efficacy of tTNS

Key Dates

Start date

Mar 27, 2026

Status verified

Apr 2026

Primary completion

Apr 11, 2027

Completion

Aug 11, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stamobil electric stimulator
• Sham Comparator: sham tTNS device

Primary Outcome Measure

Safety as assessed by the number of adverse events [ Time Frame: from start of trial to end of trial (4 weeks after start) ]

Central Contacts

• Argyrios Stampas, MD, MS
  (713) 797-5007
  [email protected]
• Jaqueline Martinez
  713-797-5765
  [email protected]

Locations (1)

Find similar trials in Houston, TX