NCT07264868NARecruiting
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
The University of Texas Health Science Center, Houston
Start Date
5/7/2026
Completion Date
9/1/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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
Interventions
DEVICE
iTNS
DEVICE
Sham iTNS
Conditions
Spinal Cord Injury (SCI)Neurogenic Bladder (NB)
Locations
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States