Home neuromodulation for bladder control after spinal cord injury
Official title: Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial
Run by The University of Texas Health Science Center, Houston · NCT07264868 · Data updated 2026-11-12
This study tests home-delivered Injectrode tibial nerve stimulation to improve bladder function in people with chronic spinal cord injury.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Status | Recruiting |
| Started | May 7, 2026 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT07264868 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with non‑progressive chronic SCI (more than 1 year) at T9 or above who are stable on bladder medications, can tolerate and evoke toe flexion with tTNS, pass a competency checklist, and can attend visits at the Houston study site.
✕Probably not a fit
People with lower motor neuron bladder, recent bladder botulinum toxin‑A injections, other central or peripheral nervous system disorders, active genitourinary cancer, pregnancy, or on anticoagulation are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional trial compares active Injectrode tibial nerve stimulation (iTNS) delivered at home with a sham iTNS procedure to determine safety and effects on bladder function. Participants are adults with non‑progressive chronic spinal cord injury (≥1 year) at neurologic level T9 or above who can evoke toe flexion with transcutaneous tibial nerve stimulation and can perform or direct tTNS. Key exclusions include lower motor neuron bladder, recent intravesical botulinum toxin‑A, other central or peripheral nervous system disorders, active genitourinary cancer, pregnancy, and anticoagulation. Outcomes focus on safety and measures of bladder control while participants remain stable on overactive bladder medications.
Why it matters
Potential benefit: If effective, home iTNS could provide a non‑surgical, self‑administered option to improve bladder control and reduce urinary symptoms or catheter dependence for people with SCI.
How similar studies have gone: Transcutaneous and percutaneous tibial nerve stimulation have shown benefit for overactive bladder in other populations, but use of an Injectrode device for home iTNS specifically in SCI is novel and not yet widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
The University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting
Study contacts
- Principal investigator: Argyrios Stampas, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Argyrios Stampas, MD
- Email: argyrios.stampas@uth.tmc.edu
- Phone: (713) 797-5938
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.