Kiran Sury, MD, on implementing ProACT for incontinence

Kiran Sury, MD

The minimally invasive incontinence treatment ProACT recently became available to patients of Allegheny Health Network (AHN) in Pittsburgh, Pennsylvania. In this interview, Kiran Sury, MD, describes his first impression and experience with ProACT in his clinical practice. Sury is a urologist with AHN in Pittsburgh.

How did you get started with using ProACT in your practice?

I was really interested in learning ProACT once I saw it came out in the 2024 AUA [American Urological Association/Society of Genitourinary Reconstructive Surgeons/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction guideline on incontinence after prostate treatment]. It was added as an official recommendation, and when something's in the guidelines, I think you at least need to be familiar with it.

The way ProACT works is, if you're fortunate to be in one of the handful of programs in the country that offers it during training, you just learn it before you graduate, but I think most urologists are going to be learning this new skill as an attending. You get set up at the company with one of their reps, and you watch seminars and training courses. I thought it was very useful to go observe another physician and watch them do the cases. And then, it's sort of training by doing. There's nothing new to this surgery that is drastically different from anything we've done. It's in the pelvis, it's in the perineum. It's anatomy I'm very familiar with as someone who does other male incontinence [procedures]. We're urologists. We own the perineum. The difference is it's percutaneous. Now, we do percutaneous procedures all the time. We do PCNL [percutaneous nephrolithotomy] or neurostimulation, that kind of thing. It's kind of combining the anatomy we're familiar with and a skill set that we maybe use somewhere else down below. It's really about learning [the feel of it].

I screened patients; I offered it to them, and once I had a group of 5 men, the company flew an expert surgeon out to proctor me. I did every step of those cases, but it was really nice to have someone there to talk shop as I did it. The truth is, [with] 1 or 2 cases, you'll probably be good to go, but with 5, I really got to experience some of the nuances, the differences that you can have, different anatomy, that kind of stuff. Now, I feel very well positioned to offer this to my patients going forward.

Based on your initial clinical experience, what are the key patient selection criteria to optimize outcomes with ProACT, especially when you're differentiating it from other minimally invasive treatments for stress urinary incontinence?

I think the first ground rule for me [right now] is [to perform this only in] nonradiated patients. That's actually in the guidelines. ProACT is listed for mild, moderate, or severe—all ranges of stress incontinence—in the nonradiated patient. Now, can you do it in the radiated patient? Absolutely. There are people who've done hundreds of cases, and at this point, they are offering this to radiated patients, and they're having good results. But if you look at the published outcomes, it's very, very clear that whatever complications you can get are much higher in the radiated cohort.

In terms of who I'm offering it to, I look at where they fall in that incontinence scheme—mild, moderate or severe—compare it to what my previous algorithm was, where I used sphincters and slings, and kind of slot them in along there. It's not necessarily that this is going to replace anything else, but it is now another option for patients, depending on where they fall along that curve. The nice thing is, because it's adjustable, it's anywhere along that curve.

Could you elaborate on the technical nuances of ProACT implantation, specifically addressing strategies for minimizing complications such as erosion or migration, and how postoperative adjustments are managed for long-term efficacy?

Just in case you're unfamiliar with the procedure, the idea is you do it with a combination of cystoscopy and fluoroscopy. You put your camera in, fill the bladder just a little bit with some contrast, and you take a good spot to mark where the external sphincter is. After that, at least the way I do it, I just leave the sheath in. This is not under cystoscopic vision. This is all by feel and X ray. You're essentially [using a] trocar [to pop] through the pelvic diaphragm and depositing this balloon on either side of the bladder neck. All the nuance comes in the feel of it. I was trained to do several safety steps along the way to make sure that, at every point, does this feel right? Instead of just using the sharp trocar to plunk through the diaphragm, I actually use a blunt trocar, and I kind of tap and feel before I pop through, just to make sure I'm lined up. I do safety checks in the AP plane to make sure I'm lined up and avoid that risk of erosion. Once the balloons are in, you watch the balloons fill live. You can get a lot of information there. Once the balloons are fully in, I put the camera back in, and you can see them. You can see an indentation, and you tug on them, and you get an idea of where it's supposed to be. I think as long as you're methodical about it, although there are absolutely complications—you can get migration if you're not across the pelvic diaphragm, erosion if you pop into the urethra or bladder—if you do these safety checks, it ends up being pretty straightforward.

In terms of the office adjustments, this was the part I was most worried about, because this is what's different from the other [procedures]. A sling is [what I call] a "set it and forget it" option. With an AUS [artificial urinary sphincter], you put it in, and then you just don't touch it for 6 weeks. You show them how to pump it, but that's just squeezing a pump. But this is something that every month, men are going to come into my clinic and I'm going to stick needles into their scrotum, because that's how it works. The balloons go in, and you tunnel these access ports, these 2 tiny little titanium ports in the scrotum. But the truth is, it was quite simple. I polled all the patients I [performed the procedure on], and essentially they feel a little prick on either side. It takes about a minute total, and there were no major complaints. Needing to come back for adjustments is something patients need to be made aware of. But the adjustments themselves were relatively painless for both patients and for me.

How do you integrate urodynamic studies and other diagnostic modalities into your pre-operative assessment for ProACT candidacy?

I was very fortunate in training to have easy access to urodynamics, and we did it on almost everybody. But I think what you'll find in the community is urodynamics is sort of a luxury. Everybody can get it, and it's nice to have it, but it's not so easy to get it on every single patient. It can delay care by several months, and patients don't want to wait. I do what I call the "poor man's urodynamics," and screen for it in different ways. I like to get an AUA Symptom Score on everybody, particularly looking for things like urgency to make sure that this is more of a stress incontinence, not an urge continence, because a lot of men after prostate treatment can have both. You can also get that from clinical history. The problem with the AUA Symptom Score is the urge question reads, how often do you find that you can't make it to the bathroom? The problem is, are these guys needing to run to the bathroom or can't make it because they have urgency, or is it just they stand up and they start leaking? To help tease that out, I'm a big fan of the penile clamp test, where, essentially, if they can handle a penile clamp for a couple of hours and it doesn't drive them crazy, then most of their going to the bathroom is probably just their leakage and not overactive bladder, because that should unmask the overactive bladder.

I also do a cystoscopy on everybody in clinic, and as I'm filling their bladder, I'm asking them how they're feeling, almost like the fill phase of urodynamics, talking to them, getting an assessment of their bladder capacity and what their sensations are. When I take the camera out, I'll have them do a standing cough test, but I have them hold off a little bit [because] that first void can sometimes be a bladder spasm. If they can't hold it at all, that's a warning sign that there might be more of an urge component. In terms of how this correlates with long-term success, I can't give you that data yet, but one of the things I am doing is I make everybody get a pad weight as part of my pre-op evaluation, and I'm having my patients track their pad weights over time. I'm hoping to 1 day be able to publish whether there is any correlation between fill volumes, initial pad weights, subsequent pad weights, and be able to track these men and get some data on how they change over time with the ProACT.

Compared to other treatments, such as the artificial urinary sphincter or male slings, what are the specific clinical scenarios where you think ProACT will be most effective, and what are the limitations?

Maybe one day in the future, I will offer this to radiated patients, but right now I'm going to use the AUS. If you think about it, that radiation, assuming it's post prostatectomy, it's right at that anastomosis; it's right at the pelvic floor, and now you're trying to put balloons there and widen these spaces that have all scarred down. [With an] artificial sphincter, I'm putting that on the bulbar urethra which, [figuratively] speaking, is miles away. The urethra is still compromised by the radiation and the hormones, but it's not directly hit in that same way. For the nonradiated patient, if you think about before ProACT, or at least the way I was trained, for mild, moderate, and severe incontinence, you've got slings and you've got sphincters. For someone with mild or moderate incontinence, a sling is an awesome option. It's set it and forget it. You put it once, you're done, and men are very happy. But we know that as they get toward moderate and then into severe, you will still improve their incontinence, but you will very unlikely get them "dry." I always put “dry” in quotation marks because it's socially dry, right? We always say 1 pad or less; I can never promise a man [that I will make them] bone dry. Some slings, you can get them bone dry. If you're leaking a lot, you will not get bone dry. That's why we have the sphincter. The sphincter is awesome. It works in radiated or nonradiated patients, but the sphincter is an active device. It's not even that much. It's just a little squeeze. But basically, every single patient I've ever spoken to would prefer to not have to do anything, vs having to do something. For the patient with moderate to severe incontinence, who is too wet for a sling and then would then have a sphincter, but this is a guy who really doesn't want that, that is the patient population that I think has been underserved, where, essentially, up till now, their options were I convince them to get a sphincter, which I think will help, or try a sling, which I'm not as certain of. A lot of times, they will want the sling first before a sphincter. That's totally fine. But now I have this third option where I can say, "let me try and put these balloons in you. I don't think a sling is going to get you dry. I can't guarantee these balloons will get you dry, but the idea is that I can adjust them to get you where you want to be. Maybe I don't get you dry now, but 6 months down the line, maybe I do. And at the end of the day, if it doesn't work, I have not burned any bridges. I can still put a sphincter in you. We can still work on this." The other thing specifically, is, this is a nice option for patients [in whom] I do not want to work around the urethra. I had a patient who had not been radiated and so was a candidate for all the [procedures], had already had a sling but was still not happy, and he had had a urethroplasty. We know that having a urethroplasty is one of the criteria for what we call a fragile urethra, which means that you're much more likely to have complications from an AUS just because of that disruption in blood supply. For him, being able to put these balloons along his bladder neck and just avoid his urethra altogether, is, I'm hoping, a much safer option for him with better long-term safety outcomes.

For health care professionals who are considering incorporating the ProACT system into their practice, what key recommendations or best practices would you emphasize to ensure optimal patient outcomes?

Every success [with surgery] comes with 2 things. One is good patient counseling, so the patients know what they're getting and they're happy when they get it. Also, making it a high-reliability operation. In terms of counseling, it's important to mention that the adjustability is a benefit, but it also takes time. For a man who has mild incontinence [and gets a] sling, the catheter comes out the next day and they're basically already dry, whereas a ProACT can take several months. They need to know that and understand that.

The other thing that I think is important, just clinically, is sometimes it gets worse before it gets better. If you look at the initial trial data in the packet, it quotes almost a 28% increased incontinence after the procedure, which makes sense, because you're disrupting the pelvic floor, and we know that's one of the things after a prostatectomy that leads to leakage. Now, this is temporary, and as they heal, it goes back to normal. The other idea is that you make the adjustments and they get drier, but just knowing that there might be that period of time before I make [the patient] better. [This] has been important as I'm talking to my own patients and following them up and seeing them every month.

In terms of making it a safe, highly reliable operation, if you're comfortable with slings and sphincters, you are very well positioned to learn this surgery. This isn't something that you need to spend months and months training. We know all these skills. We're just applying them in a new way. There's no real new equipment or anything like that. I had 5 cases with the proctor. It doesn't have to be 5. It can be as little, 2, because, as I said, you'll know how to do the case after that. But I really appreciated having all 5, because it's such a spectrum. The patients were all nonradiated, but [they had] a lot of different types of clinical factors. In my case, I had Steve Nash [, MD], as my proctor, and he was one of the original principal investigators, bringing ProACT to America with the FDA studies. He is just a phenomenal surgeon and an excellent mentor. In between cases, I was just asking essentially every clinical scenario I could think of. It helped ramp up my own comfort. When I was doing the 5 cases, by the last couple of cases, I told him, “Let me pretend you're not even here." I did the cases, and he gave me feedback afterwards. That kind of confidence moving forward, knowing that, in fact, I do get it and I can do this operation, has really helped me. I would encourage anybody else going forward to take your time, get the full 5 patients, and take full advantage of having someone there with you to help guide you through this.