The first patient has been implanted in a Defense Department-funded clinical trial evaluating Neuronoff’s Injectrode device for the treatment of neurogenic bladder in people with spinal cord injury.
The study is being conducted at UT Health Houston under principal investigator Argyrios Stampas, MD, professor of physical medicine and rehabilitation at Houston-based McGovern Medical School, according to a June 5 news release. The double-blind, randomized, controlled trial will enroll 21 participants across three groups: unilateral active stimulation, bilateral active stimulation and sham stimulation.
Neurogenic bladder is a common complication of spinal cord injury and can contribute to recurrent urinary tract infections, kidney damage and reduced quality of life. The Injectrode is designed to deliver tibial nerve stimulation through a minimally invasive outpatient procedure using a single needle placement adjacent to the tibial nerve.
The trial’s primary endpoints will evaluate safety, stimulation accuracy, reliability, procedural feasibility and physician and patient acceptability at four and eight weeks. Secondary endpoints will assess bladder function and changes in overactive bladder medication use.
Data from the study will support discussions with the FDA and help inform future pivotal trials for the device, according to the release.
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