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

RecruitingNAAges 8 Years - 18 YearsAllUniversity of Texas Southwestern Medical Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Transcutaneous Tibial Nerve Stimulation (TTNS) treatment
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Where

1 site
Scottish Rite for Children
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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