RecruitingNot ApplicableNCT07264868

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury

Home Neuromodulation for Neurogenic Bladder Management in Spinal Cord Injury: A Hybrid Implementation-Efficacy Trial

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

21 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury (SCI)Neurogenic Bladder (NB)

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEiTNS

The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.

DEVICESham iTNS

The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.