US-based Bioness has started a Canadian pilot study of the StimRouter Neuromodulation System for the treatment of overactive bladder (OAB).
Four patients have currently successfully been implanted with the StimRouter Neuromodulation System to evaluate the device in the treatment of overactive bladder symptoms.
StimRouter, a minimally invasive neuromodulation medical device, secured FDA clearance as a treatment for chronic, intractable pain of peripheral nerve origin.
This minimally invasive technology is being examined as an alternative treatment for the 35 million people in the US who suffer from overactive bladder symptoms and the 10 million who receive treatment for it, which contributes $66bn in annual cost to the US healthcare system.
During the pilot study, patients with documented refractory overactive bladder will receive tibial nerve stimulation via the StimRouter implantable lead and external pulse transmitter.
The company said patients will manage their treatment at home in accordance with the defined protocol, with periodic in-clinic outcome visits.
The neuromodulation device is equipped with a feature to make a track of the usage and compliance during the six-month trial.
StimRouter showed efficacy in relieving peripheral nerve pain and this technology has the potential to be used for more applications.
Bioness president Todd Cushman said: “The StimRouter is a platform technology with a design that we believe has applications outside of its current indication, chronic peripheral pain.
“This pilot study demonstrates the first of several investigations with the goal of expanding StimRouter use in markets of unmet need or existing markets that seek the appropriate neuromodulation solution.”
StimRouter consists of an implanted lead, external pulse transmitter (EPT) and conductive electrode, controlled by a small handheld wireless control unit.