Recruiting

tTNS

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07136688

Conditions

Neurogenic Bladder Due to Spina Bifida

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Interventions

Stamobil electric stimulator

sham tTNS device

Study Details

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

Conditions

Neurogenic Bladder Due to Spina Bifida

Study ID

NCT07136688

Start date

Mar 27, 2026

Status verified date

Apr, 2026

Completion date

Aug 11, 2027

Anticipated

Primary completion date

Apr 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • chronic neurogenic bladder
  • Spina Bifida diagnosis
  • Use of overactive bladder medication(s)
  • Stable bladder medications for ≥ 3 months

Exclusion Criteria:

  • 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)

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stamobil electric stimulator

sham comparator: sham tTNS device

Interventions

Stamobil electric stimulator

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

The electric sham stimulation protocol will use sham stimulation (low intensity) for 30 minutes daily, for 4 weeks , 5 days per week

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) ]
  • Feasibility as assessed by the satisfaction surveys [ Time Frame: end of study (4 weeks after baseline) ]
  • Compliance of tTNS usage as assessed by the percent of sessions where toe flexion was elicited [ Time Frame: from start of trial to end of trial (4 weeks after start) ]
  • Compliance of tTNS usage as assessed by the average current where toe flexion was elicited [ Time Frame: from start of trial to end of trial (4 weeks after start) ]
  • Compliance of tTNS usage as assessed by percentage of sessions that bladder medications were taken [ Time Frame: from start of trial to end of trial (4 weeks after start) ]
  • Satisfaction as assessed by the survey [ Time Frame: end of study (4 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Argyrios Stampas, MD, MS

(713) 797-5007Argyrios.Stampas@uth.tmc.edu

Jaqueline Martinez

713-797-5765Jacqueline.B.Martinez@uth.tmc.edu

Locations

The University of Texas Health Science Center and Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Argyrios Stampas, MD,MS

713-797-5007Argyrios.Stampas@uth.tmc.edu

Jaqueline Martinez

713-797-5765Jacqueline.B.Martinez@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • spinal cord injury (SCI)
  • transcutaneous tibial nerve stimulation (tTNS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-04-08.