Actively Recruiting
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
Led by The University of Texas Health Science Center, Houston · Updated on 2026-05-11
21
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-progressive chronic spinal cord injury lasting more than 1 year
- Neurologic injury level at T9 or above
- Stable on overactive bladder medications for at least 3 months
- No MRI contraindications
- English or Spanish speaking
- Able to tolerate and evoke bilateral toe flexion with transcutaneous tibial nerve stimulation (self or assisted)
- Pass the competency checklist to perform or direct transcutaneous tibial nerve stimulation
You will not qualify if you...
- Active or ongoing genitourinary cancer diagnoses
- History of other central nervous system disorders or peripheral neuropathy
- Pregnant or planning to become pregnant
- Diagnosed with lower motor neuron bladder
- History of bladder surgery such as augmentation cystoplasty
- Received botulinum toxin-A injections in the bladder within 6 months prior to enrollment
- Current anticoagulation treatment or prophylaxis
- Advanced peripheral vascular disease (e.g., gangrene or amputation)
- History of intolerance to electrical stimulation, especially of the leg
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Argyrios Stampas, MD
CONTACT
D
Danira Garcia Gutierrez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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