Transcutaneous Tibial Nerve Stimulation (TTNS) Treatment in Spina Bifida Pediatric Patients With Neurogenic Bladder

ConditionSpina Bifida
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous Tibial Nerve Stimulation (TTNS) treatment

Treatment groups

12 Participants
are divided into 1 treatment group