Dr. Syan recaps AUA 2024 sessions on urodynamics, PTNS devices

In this interview, Raveen Syan, MD, highlights 2 sessions that she took part in during the 2024 American Urological Association (AUA) Annual Meeting in San Antonio, Texas on urodynamics in the context of the VALUE trial (NCT00803959) and the new wave of percutaneous tibial nerve stimulation (PTNS) devices. Syan is an assistant professor of clinical urology at the University of Miami in Florida.

This transcription has been edited for clarity.

Raveen Syan, MD

At this year’s AUA, you were a part of the session, “UDS and Female SUI in the Era of the VALUE Trial: Is it Needed? Debate and Panel Discussion of Cases with Audience Response.” Could you provide an overview of this discussion?

Urodynamics is a study to evaluate bladder function. It's minimally invasive, but it's still invasive; it requires a catheter in the bladder. It's not a painful procedure, but it's uncomfortable. It does require patients interacting with providers while they're urinating, so patients don't really look forward to the study. However, it provides excellent diagnostic understanding of bladder function during filling and emptying. So, it's a really valuable tool, but we don't want to overuse it either. The guidelines published by the AUA and SUFU [Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction] focused on the uncomplicated patient with stress urinary incontinence. Do they really need to undergo urodynamics prior to undergoing surgical therapy for stress urinary incontinence? That's what the VALUE trial was aiming to [understand]. They had pretty strict criteria to define an uncomplicated straightforward stress incontinence patient. They randomized to either undergo majority sling, some bulking vs urodynamics and then a sling. They show that urodynamics had no impact on patient outcomes, patient quality of life, or success of the operation. So, really in the uncomplicated patient, you don't need to perform urodynamics.

Now, the uncomplicated patient is the minority. The majority of patients have some degree of other bladder issues. It might be over activity, it might be under activity, there may be some component of obstruction. Even in the VALUE trial, only 33% of patients met criteria for being the uncomplicated patient. So, the debate really is, "Okay, so how far can we push the findings from VALUE trial? How much can we avoid an unnecessary procedure in our patient population?" And I argue the side that we should use diagnostics when there are hints of possible underlying other disorders, because this will help us with patient counseling and management of post-operative outcomes, if they elect for surgery, and other treatment options if they exist.

At the AUA, you also participated in the session, “Panel Discussion: Management of Refractory OAB - The New Crop of Implantable PTNS Device.” Could you provide an overview of this discussion?

Overactive bladder is a very common disorder that people experience, and unfortunately, it can be quite resistant to treatment. A lot of oral therapies exist out there, but they're limited in efficacy. Fortunately, we have amazing innovations in device developments that can really improve overactive bladder. One of them is the classic percutaneous tibial nerve stimulation. The way I describe it to patients is it's like a tiny little acupuncture needle; it doesn't cause any bleeding. We insert it right at the ankle where the tibial nerve is. The tibial nerve connects all the way back up at the spinal cord level to the big nerve, S3, that goes to the bladder. By coming to clinic once a week for 30 minutes for 12 weeks, patients just get a little electrical therapy session, [they can] bring a book and for 30 minutes get a little buzz sensation in their ankle. It's quite effective; it's 70%, effective at improving overactive bladder.

The big challenge is patients have to travel once a week. Visits to the clinic are really burdensome, and we're talking about 3 months of weekly visits. Also, as we know, in America, access to specialized care is really limited outside of our major cities. Fortunately, companies have developed the opportunity for implantable devices. There are 2 FDA approved devices, called the BlueWind Revi and the Valencia eCoin. [They are] very similar in that they involve the implantation of a small component. With BlueWind, you wear a little ankle sock that allows you to give therapy to yourself. When you're at home, you just turn it on. The eCoin, once it's implanted, you don't have to think about it. eCoin turns on and off on its own. Really, the advent of these new therapies is to improve access to care for patients and [provide] less burdensome care in terms of transportation and time off work. The debate is to decide which one is better. It's a blessing and a curse to be in a field that has so much innovation. It's a blessing because innovation is good for patients and for physicians and for everybody. Curse, because how do we decide which one? That's really what the debate was about, helping clinicians decide which one to pursue or which one is right for one patient vs another.

Building off that, how do you determine which device is better suited for each patient?

I think that's really the challenge, right? Some patients like the idea of having complete control. The BlueWind Revi allows for that. It's almost like a little tiny capsule that we place under the skin. You can barely feel it. The patient decides when they want to give themselves the therapy. They actually wear this little ankle brace, and they turn it on and off. They have complete control in that scenario.

Some other patients may not want to think about it at all. They want the little device to do the work for them. That would be the Valencia eCoin, which as I mentioned, it's just on and off on its own. The patient doesn't have control over it. It really comes down to what patients feel about the control or lack thereof that they want of their device. As someone who does do a lot of implantation, specifically sacral neuromodulation, I can tell you patients know what they want. They know whether they want to be aware or unaware. Again, it's really great to be able to provide patients the option.

Are there any emerging applications for these devices or additional potential in the field?

One of the innovations that I think the field needs to turn to is neuromodulation efficacy in neurogenic bladder. We really shied away from looking at neuromodulation in this population because previously, these devices were MRI incompatible, and patients with neurologic diseases often need MRI imaging. Other issues are when you lack sensation, you may not feel pain or infection. So, it's a really under explored area. With the implementation of these low-risk, minor procedures, placing it in the clinic, I think the opportunity to examine neuromodulation efficacy in various neurologic conditions—MS, stroke, Parkinson's disease, spinal cord injury, incomplete spinal cord injury—is really where we should turn our attention and explore.