Emerging Technologies in Urology: A Glimpse Into Tibial Nerve Stimulation for Bladder Dysfunction Treatment - Diane Newman & Howard Goldman

May 30, 2023

In this discussion, Diane Newman, talks with Howard Goldman about advances in neuromodulation technology for patients with lower urinary tract dysfunction, overactive bladder, and urinary incontinence. Dr. Goldman highlights the potential of implantable tibial nerve stimulation devices, particularly a small device developed by BlueWind Medical. The device, placed next to the tibial nerve, is powered externally and stimulates the nerve to manage bladder function. Dr. Goldman reveals that early data from FDA submission studies has shown excellent results with minimal complications. The outcomes from this device,  seem comparable to those from sacral neuromodulation, which has been considered the gold standard in the field. Neuromodulation technologies in general have a very favorable risk profile, and these advancements in the field offer promising non-invasive options for patient care.


Howard Goldman, MD, FACS, Urologist, Professor, and Vice Chairman, Glickman Urologic Institute, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic, Cleveland, OH

Diane K. Newman, DNP, ANP-BC, BCB-PMD, FAAN, Urologic Nurse Practitioner, Adjunct Professor of Urology in Surgery, Research Investigator Senior, Perelman School of Medicine, University of Pennsylvania, and Former Co-Director of the Penn Center for Continence and Pelvic Health, Philadelphia, PA

Read the Full Video Transcript

Diane Newman: Welcome. I'm Diane Newman. I'm an adult nurse practitioner at the University of Pennsylvania in Philadelphia. I'm also adjunct professor of urology and surgery. I'm excited today because I have a guest here, Dr. Howard Goldman, who's a urologist at Cleveland Clinic, and he's going to talk to us about new technology in the field of neuromodulation for men and women who have lower urinary tract dysfunction, overactive bladder, urinary incontinence. He's going to describe some new technology for us.

Howard Goldman: So I'm Howard Goldman, professor vice chair at the Cleveland Clinic in the Department of Urology. One of my interests is with is neuromodulation for overactive bladder. Actually there's a lot going on in that field. One of the big areas right now with actually a number of different designs and products in different companies is an implantable tibial nerve stimulation.

So we know from the past that if with little percutaneous needles, you can stimulate tibial nerve, but again, it requires many trips back and forth in, but it requires many trips in and out of the doctor's office, the nurse's office, in order to get that done. So the idea was, is there a way to stimulate the tibial nerve on a more regular basis without the patient going back and forth? So number of companies are looking at this. One that I have a lot of familiarity with is BlueWind, which is a company that's been around for, I don't know, 6, 7, 8 years. They have a very small device that is implanted right next to the tibial nerve. The nice thing about this is at the recent, AUA meeting, their FDA submission study, the data was just presented. So before I get to that, what the results were, it's a very, very small stimulation device and there's no battery in it. The energy comes externally. So what happens is this very small, it's almost like half a matchstick is implanted right next to the tibial nerve.

Diane Newman: That's near the ankle, right?

Howard Goldman: That's in the ankle near the medial malleolus. That's allowed to heal. Then they have an external little device that they wear on their ankle probably a few times a week for half an hour or so. The energy is transmitted from that device to this little thing that's next to the tibial nerve and then that causes the stimulation of the nerve. So it's very well tolerated. They finished their study somewhere about six to 10 months ago. So they now have good objective data that goes out at least six months. The results were excellent. I mean very, very well tolerated. Very few complications, and the outcomes were almost at the same level of sacral neuromodulation.

Diane Newman: Really that's an implantable device that really is a much bigger procedure. But did you test it in men and women? What age group?

Howard Goldman: It was tested in men and women, young to old. It was a large group, multi-center, US and Europe. It's very, very strong data, very, very positive outcomes, quite frankly. I was in charge of the data safety monitoring board, and when I saw the outcomes, I was quite surprised because it was actually a lot better efficacy than I even expected. Many of us thought sacral is the gold standard for neuromodulation, and that tibial will be not that far behind. But quite frankly, when you look at their data, again, I would encourage people to look at the AUA website, look at their data. It's quite remarkable.

Diane Newman: Wow. Explain to our audience what is neuromodulation.

Howard Goldman: So neuromodulation is applying electrical stimulation. Well, typically when we think about it, it's applying electrical stimulation to a nerve that will then modulate different body functions. So where we use it in bladder function is by applying it to nerves to typically feed back to some of the sacral nerves and thereby modulate bladder function because a lot of the bladder function comes through S2, S3, S4.

Diane Newman: That is your base of your spine, correct?

Howard Goldman: That's at the base of our spine. So the sort of gold standard, what's been around for the last 25 years is sacral neuromodulation, where a lead is placed near the sacral nerve, it's tested. If you have a good response, then some kind of stimulator with a battery is implanted. Now there are some that are rechargeable. But that's what we've had for many years.

There are now a lot of different studies looking at other nerves. Everything from, there's a study looking at the genital nerve. There are a number of studies. There are a bunch of studies looking at the tibial nerve, some are looking at the saphenous nerve. So there are a lot of other nerves that people are looking at that all sort of feed back to the sacral nerves, which are involved in bladder function and looking to utilize this sort of stimulation for either patients who go to the bathroom too often, overactive bladder, and paradoxically, at least with sacral neuromodulation, it also works on patients who have idiopathic non-obstructive retention. So patients who can't urinate. So for those where you go too often, it slows things down and for those who can't go, it sort of wakes it back up. So there's a lot we don't know, but it's a very exciting field.

Diane Newman: For urology, right, we are seeing more and more technology in that area of neuromodulation and really not that invasive that we are going to have devices, new technology that's really going to assist individuals that is going to have low risk.

Howard Goldman: Yes, I mean all of the neuromodulation technologies that we deal with right now, and of course sacral neuromodulation is the one we've dealt with for the longest, really have very, very, very favorable risk profiles. I mean, the biggest complication in general that we have with sacral neuromodulation is probably 1% infection rate. The nice thing with neuromodulation is in a worse case scenario, you could stop it, take it out, you don't burn any bridges. That's the beauty of neuromodulation.

Diane Newman: Yeah. Well thank you very much for explaining this and I'm really excited about the growth in this field.

Howard Goldman: You're welcome. My pleasure.