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 7, 2026

Study Type

INTERVENTIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sham iTNS and a medical device called iTNS for people with neurogenic bladder (nb) and spinal cord injury (sci). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT07264868


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