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Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
Recruiting
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: * Non-progressive chronic (\>1 year) SCI * Neurologic level of injury T9 and above * Stable over active bladder (OAB) medications (≥3 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
About the study
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.
What is being tested
- iTNS (device)
- Sham iTNS (device)
Sponsor: The University of Texas Health Science Center, Houston · Participants: 21 · Started: May 7, 2026
Contact the study team
- Argyrios Stampas, MD · Phone: (713) 797-5938
- Danira Garcia Gutierrez · Phone: (713) 797-7133
Official record on ClinicalTrials.gov — NCT07264868
Locations in the U.S.
| Texas | The University of Texas Health Science Center at Houston, Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.