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"The improvement is sustained, but over time it does tend to decrease and we're currently trying to figure out why," says David Sheyn, MD.
In this video, David Sheyn, MD, highlights the use of Axonics therapy at University Hospitals to treat patients with bladder and bowel dysfunction. Sheyn is the Division Chief of Female Pelvic Medicine at University Hospitals and an assistant professor of urology and reproductive biology at Case Western Reserve University in Cleveland, Ohio.
Video Transcript:
It's sacral neuromodulation, which means that we take advantage of the innervation of the bladder to the third sacral nerve. This therapy impacts the signaling, both afferent and efferent signaling from and to the bladder. The exact mechanism is not clear, but what we think it does is interrupts the flow of information from the bladder to the spinal cord and suppresses the urge in that voiding reflex. This therapy has been around for about 25 years, but over the years, it's undergone multiple innovations. The current iteration of this through Axonics is it's a battery that is implantable and can last for up to 20 years, depending on how high the amplitude is of the voltages of the battery. [That's] certainly a lot more than the 3 to 5 years that it's been initially. It's a lot easier to implant than it has been in the past. It can be completed all in a 30-minute procedure. The testing is a lot easier; we can do a lot of it in the office now. It's a lot more precise. The difference between an office evaluation and what we call an advanced trial that's done in OR in terms of a positive outcome is very small. So, a lot of patients can now be saved from 2 trips to the OR; they can get by with just 1.
The most important thing is how effective it is. What we quote patients usually is 80% of patients get at least 50% better. That cut off came from research studies, just because we need to have some idea of what improvement is. Obviously, most patients won't accept that they're 50% better. They want a lot more improvement. But I would say just for our own data, about 90% of our patients get substantially more than 50% improvement, and roughly 40% to 50% we would say are symptom-free for years. The conditions that this therapy can be applied for are urge incontinence, urinary idiopathic retention, meaning people who can't empty their bladder, but we have no specific cause for this. Even most people with neurologic conditions that we think are causing these symptoms, who in the past could not have had an implant because of the demand for MRI, now that these devices are more compatible, all these patients are now getting it. So I have a lot of patients with multiple sclerosis, with Parkinson's, who are benefiting from this type of therapy. The other big one is fecal incontinence, which is just a very debilitating condition. The thing is it works equally well for all of these, more or less. Maybe not as well for the retention as urge incontinence, but quite good results with all of these issues.
The improvement is sustained, but over time it does tend to decrease and we're currently trying to figure out why. Is it because of scarring? Is it because of migration of the lead? Is it something with the disease itself? Is it progressive? We're not sure, but we partnered with [Axonics] to help answer some of these questions. We're doing some studies with them specifically. We're also looking at our own investigator-initiated trials looking at the actual position of the lead relative to the nerve on MRI, which before, we couldn't do. Now we can image the geography of the lead relative to the nerves and see if that has anything to do with the way patients respond to this therapy.
This transcription has been edited for clarity.