NCT07264868 · The University of Texas Health Science Center, Houston
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
What this study is about
The purpose of this study is to determine the safety and effectiveness of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations