Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

The University of Texas System (UT)

Status: Withdrawn

Conditions: Neurogenic Bladder

Treatments: Device: Vivally system stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06661057

HSC-MS-24-0834

Details and patient eligibility

About

The purpose of this study is to assess and optimize the Avation electric stimulation system output and electromyography (EMG) processing to stimulate the tibial nerve in people with chronic Spinal Cord Injury (SCI) who have foot muscle atrophy and edema, both of which may affect proper device operations, to evaluate the safety, feasibility, and effectiveness of Avation Electric Stimulation System for bladder neuromodulation in people with SCI and identify barriers to implementation of the existing Avation Electric Stimulation System to help with developing it towards a new indication for routine care of SCI NB.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Injury level above T10.
• Diagnosis of neurogenic bladder (Performing intermittent catheterization).
• English or Spanish Speaker.
• Toe flexion upon tibial nerve stimulation with transcutaneous electric stimulation.
• No adverse events during the Vivally 5-minute trial

Exclusion criteria

• Intradetrusor Botulinum Toxin within six months.
• Presence of urinary tract infection (UTI) symptoms.
• Pregnancy or breastfeeding.
• Known allergy to electrode or device materials.
• Known intolerance to leg electric stimulation
• Patient with no smartphone access.
• Pain/discomfort or adverse reaction with the trial of toe flexion.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Vivally system

Experimental group

Treatment:

Device: Vivally system stimulation