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โ† Trials
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Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

RecruitingNAAges 18 Years - 75 YearsAllThe University of Texas Health Science Center, Hoโ€ฆ
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Non-progressive chronic (\>1 year) SCI * Neurologic level of injury T9 and above * Stable over active bladder (OAB) medications (โ‰ฅ3 months) * No contraindication to MRI (per MRI Safety Questionnaire) * English or Spanish speaking * Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted) * Pass the tTNS competency checklist to perform or direct performance of tTNS. Exclusion Criteria: * Ongoing/active genitourinary oncologic diagnoses * History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy * Pregnancy or planning to become pregnant. * Lower Motor Neuron bladder * Restorative bladder surgery such as augmentation cystoplasty * Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed) * Anticoagulation treatment or prophylaxis * Advanced peripheral vascular disease (gangrene, amputation, etc.) * History of intolerance to electrical stimulation, particularly of the leg
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What it tests

  • iTNS
  • Sham iTNS
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Where

1 site
The University of Texas Health Science Center at Houston
Houston, 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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