Recruiting

TTNS

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06025734

Conditions

Spina Bifida

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) treatment

Study Details

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 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

Spina Bifida

Study ID

NCT06025734

Start date

Nov 18, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: TTNS Treatment Arm

Treatments Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session) During treatments, patient may experience a tingling sensation in the foot/ankle. Patient may have discomfort in the area when first adjusting to the correct amount of stimulation for patient.

Patient will have a visit with your doctor after 6 weeks of treatment at Scottish Rite. If patient have a good response to the treatments, they may be extended for another 6 weeks.

After treatments Bladder diary (completed at home, on paper over a 3-day period, recording catheterization volumes and amount of leakage by weighing pads/diapers) Complete questionnaires on paper (about 10 minutes) Complete urodynamic testing at Children's Medical Center (approximately 45-60 minutes).

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) treatment

Spina Bifida pediatric patients with neurogenic bladder will be in Transcutaneous Tibial Nerve Stimulation (TTNS) treatment. Patient will complete 6 weeks of 30 minute treatment sessions (these can be done at home after the first teaching session)

Primary outcome measure

  • Number of leakage episodes [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Alexandra Carolan, MD

214-456-5632alexandra.carlon@utsouthwestern.edu

Shreedhar Reddy

shreedhar.reddy@utsouthwestern.edu

Locations

Scottish Rite for Children

Recruiting

Dallas, Texas, United States, 75219

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Feb 12, 2026

Last verified

Feb, 2026

Keywords

  • Pediatrics
  • Neurogenic bladder
  • TTNS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-02-12.