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.
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)
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
Single group
Transcutaneous Tibial Nerve Stimulation (TTNS) treatment
DeviceSpina 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)
Number of leakage episodes
Number of leakage episodes will be measured by 3 Day Bladder Diary
Leak weight
Leak weight of the diapers will be measured by wet-diaper weight in grams
Number of pads used
Number of pads used will be measured using 3-day bladder diary
Number of diapers used
Number of diapers used will be measured using 3-day bladder diary
Quality of Life Assessment in Spina Bifida Score
Quality of life (QoL) is measured by QUALAS assessment tool. QUALAS stands for Quality of Life Assessment of spina bifida. There are separate (but largely similar) versions for adults (QUALAS-A), children aged 8-12 (QUALAS-C) and teenagers (QUALAS-T). Each of these have further "domains" (that are scored from 0-100) that are aggregated to report quality of life scores (see below): 2 domains each for QUALAS C and T, and 3 domains for QUALAS-A. Lower scores in C and T indicate better QoL. But in QUALAS A it is mixed (Domain 1 -'Health and Relationships' : Higher scores indicate better QoL; Domain 2- 'Esteem and Sexuality' : Lower scores indicate better QoL ; Domain 3- 'Bowel and Bladder' : Lower scores indicate better QoL)
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