Commentary
Video
Author(s):
“I think the long and short of it is we know tibial nerve stimulation works, we're just trying to identify what's the best way by which we can deliver it conveniently and cost effectively to the patient,” says Suzette E. Sutherland, MD, MS, FPMRS.
In this video, Suzette E. Sutherland, MD, MS, FPMRS, discusses what is coming down the pipeline for tibial nerve stimulation, which was highlighted during a session at the 2024 SUFU meeting titled, “What’s available in Tibial Nerve Stimulation and What’s Coming.” Sutherland is an associate professor in the department of urology and the director of female urology at the University of Washington Medical Center in Seattle. Sutherland also served as an investigator on the FDA approval trial for BlueWind’s Revi System.
Video Transcript:
As far as what's coming down the pike, there are other companies who are developing their own implantable tibial nerve options. Medtronic, of course is one, and then Coloplast is another. The FDA approval trials are underway at this point. There are slight differences between these types of products. I'm not on either of these trials, so I'm not privy to all of the details and have signed a non-disclosure agreement. What I do know is that they're also very small, easily implantable, one with a rechargeable battery, one with external aspects again. They're just variations on the theme, on how to actually deliver the stimulation to the tibial nerve. I think the long and short of it is we know tibial nerve stimulation works, we're just trying to identify what's the best way by which we can deliver it conveniently and cost effectively to the patient.
One advantage about having the implantable device without the implantable battery is that there's very little hardware that's implanted. Then also, the patient does their sessions at home. As I alluded to, the FDA approval trial had the patients doing 30-minute sessions twice a day, at least to start. That was to try and find a uniform plan that everyone was going to do so the comparisons could be made. As we get more experienced with this now that it is FDA approved, what's nice is that patients can tailor it to their own needs. One patient might only need it once a week, and another might need it every day, or every third day, or maybe just when they start to notice some symptoms coming back, then they do it. There are a lot of unanswered questions about this neuromodulation therapy in general. We do know it works when it's applied in a uniform regular way, but we don't know how much we can deviate from that regular uniform way and still have good efficacy. I think that's what we're going to learn as more experience happens with these implantable, easy to use at-home devices.
This transcription has been edited for clarity.