Q&A: Where ProACT fits in the male stress urinary incontinence algorithm

Adjustable balloon therapy now holds a defined place in the treatment algorithm for male stress urinary incontinence (SUI). The 2024 amendment to the AUA/GURS/SUFU Incontinence After Prostate Treatment guideline states clinicians may offer adjustable balloon devices to nonradiated patients with mild to severe SUI after prostate treatment (Conditional Recommendation; Evidence Level: Grade C).¹ In the US, ProACT Adjustable Continence Therapy is also the focus of a 5-year post-approval study (NCT03767595) evaluating long-term urethral stricture and device erosion.

Kiran Sury, MD, a reconstructive urologist at Allegheny Health Network (AHN) in Pittsburgh, Pennsylvania, spoke with Urology Times® about ProACT for men with SUI. He explained the device’s mechanism, his approach to patient selection, the expected adjustment timeline, and long-term durability. He also discussed how tissue quality and prior radiation shape outcomes and emerging electronic sphincter technology.

This Urology Times Q&A has been edited and consolidated from a recorded interview to improve readability while preserving the substance of the original conversation.

Urology Times: How does ProACT work, and how does it differ from slings and the artificial urinary sphincter?

Sury: People who deal with urinary incontinence will be very familiar with slings and the artificial sphincter. They’ve been around for decades. Just [for background,] a sling is a piece of mesh that goes in and helps reposition the urethra and cause some coaptation. I consider it a passive device. You set it and forget it, and you get your results.

The sphincter is a little bit more complex. It’s a 3-piece device. It’s like a miniature clamp or a tiny blood pressure cuff that goes around the urethra [and] squeezes it closed. The sling relies on what you bring to the table in terms of your sphincter function, [but] it’s going to do its job every time. It is more of an active device, because every time you want to pee, you have to squeeze a little button.

ProACT basically answers the question, what if we gave you back your prostate? We put 2 balloons in on either side of the bladder neck where the prostate used to be, and those provide coaptation. They push in, similar to Bulkamid [polyacrylamide hydrogel] or any of the injectables that people use for female stress incontinence. Like the sling, from the patient’s perspective, it’s set it and forget it. They’re not pressing anything to get it to work. The balloons are always there, providing that closing pressure.

But unlike the sling, it’s adjustable. So once a month, you can come back to clinic, keep track of your leakage, and we can add more fluid to the balloons. That makes the balloons bigger, which pushes in on the urethral lumen more. It’s not always a guarantee, but the goal is to get that sweet spot where you are blocked enough that you don’t have any urinary leakage, but not so blocked that you struggle to pee. You pee with your normal function, exactly like how it used to be when you had your prostate.

Urology Times: Who is the ideal candidate for ProACT, and where does it fit in your treatment algorithm?

Sury: The initial incontinence after prostate treatment guideline was 2019, but in 2024 they added ProACT as an option, and they said [it is an option for] any type of incontinence—mild, moderate, or severe—for non-radiated patients. So I think it can work on almost anybody.

ProACT does require adjustments, so for someone who has mild stress incontinence, I often will still consider a sling, because that can do the same job, and they don’t need to come back for adjustments. For severely incontinent patients, I still think the artificial sphincter is the gold standard on the market and is likely the best guarantee of dryness that you can get. That said, I have gotten people 95% to 99% dry with ProACT, and these are patients with what I would consider severe leakage, over 700 g.

There is also some efficacy in radiated patients, which I’ve started to test the waters with, but I would say for someone introducing ProACT into their treatment algorithm, stick with the non-radiated patients. The tissue isn’t as fixed, so we think you get better coaptation and the risks of things like erosion are less.

But I absolutely think you can offer this for mild, moderate, or severe [incontinence], with the understanding that the worse [the] leakage, the less likely you are to get them completely dry. For some patients, it really comes down to: Are they willing to squeeze a button to use an AUS [artificial urinary sphincter], or do they want totally hands-free? A lot of guys are willing to at least try ProACT before moving on to a sphincter.

Urology Times: How many adjustments should patients expect after ProACT implantation?

Sury: All of our long-term data comes from Europe. This device has been out there for 15 to 20 years. [It] came to the US in 2015, but it was going through FDA testing, and it only got its official Medicare code in 2023. So it only has 2 or 3 years of US market data.

In terms of adjustments, when we put these balloons in, the stated recommendation is anywhere from 0.5 cc up to about 1.5 cc or 2 cc. The balloons hold a max of 8 cc, and you usually fill them each side. So when I say 8, it’s actually 8 + 8 makes 16, but we don’t do the total math; it’s just how much [is in] each side. I think a pretty standard number is people start off filling it with 1 cc or 1.5 cc.

Data comparing multiple studies showed a median fill volume of around 4 cc, so I tell patients, “I expect you to need adjustments.” It’s very rare that you just put the balloons in and you’re instantly dry. That’s not how they were designed. They’re designed [so] you put in a little bit and you adjust them over time.

If you consider that we go up by about 1 mL every visit, then if you’re going from, let’s say, 1 cc to 4 cc, that’s at least 3 months of adjustments. If you’re going from 1.5 cc to 8 cc, that’s about 6 months of adjustments. So I tell patients [to] expect 3 to 6 months of adjustments before either we’ve gotten you dry and you’re happy, or I’ve maxed out the balloons at 8 cc, and what you get is the optimal result you’re going to achieve from this.

Urology Times: How durable are continence outcomes once the balloons are set?

Sury: There was a study [published in] 2019 where they adjusted [patients], and then they followed them for about a median of [118 months].² They did find that once the balloons had been set, they maintained.

For an artificial sphincter, we quote a standard shelf life [of about] 8 to 10 years. We know they wear out, but it’s also a mechanical device pushing fluid back and forth with moving parts. Here, there are no moving parts, so theoretically, it should last forever. I don’t think that’s entirely true. Even though the balloons are silicone in the body, you have the potential for fluid shift, so you can have fluid loss over time.

I counsel men [by saying] that the balloons may be perfect and last forever, but the men aren’t. You age, and as you age, your sphincter doesn’t quite work as well. Your tissues atrophy. It’s a very common thing, and it’s a reason why guys will have a sling and be totally happy, and then 10 years later say they’re starting to leak again. The sling didn’t move out of the way or dissolve. The body aged. I don’t think with any device we have on the market we can truly say, “you do this and you’re done forever.” But I do think for the balloons, if they get you the result you want, it’s a durable device.

Urology Times: How does tissue quality after radiation or prostatectomy complications affect ProACT placement and outcomes?

Sury: It’s critical. [This is] something to take very seriously. When you do a sling or a sphincter, you are making an incision in the perineum and dissecting down to the urethra, as opposed to ProACT, [where you’re] just making 2 tiny incisions and stabbing the trocar, which they say is [an] easier or faster surgery. But [for a sling or sphincter,] that urethra, whether they’ve been radiated or not, is technically almost a virgin plane. Radiation worsens outcomes for all surgeries, but it’s not that they radiated exactly in the urethra where you’re cutting. It’s that they were radiated overall, and that affects blood flow.

ProACT goes at the bladder neck where the prostate used to be. When you get radiated for prostate cancer, that is the prime target. Now you’re trying to put balloons there. The data is very clear [that], as with all devices, you have higher risks of erosion from that coaptation in radiated patients. ProACT certainly has that.

Urology Times: How does scarring at the bladder neck affect balloon placement and perforation risk?

Sury: I have found that patients can have scar tissue around their bladder neck from their prior surgeries that you don’t really know about until you try. I have also had non-radiated patients who did have scar tissue there. I’ve had patients where, with the scar tissue, the balloon, instead of being symmetric and round, was almost squished up a little bit, like origami. [However the] patient’s dry and happy, so you don’t need to have that perfect deployment of the balloon.

I have found [in] people who had complications around the bladder neck, ProACT can work. There’s actually an incredible case report³ where [the authors] had a patient who had multiple [prior] artificial sphincter erosions. Ultimately they did an open ProACT, where they dissected all the way down to the bladder neck and put the balloon exactly where they wanted it. [They were] finally, [several] surgeries later, able to get a good result. So it can work. But with people who have had complications from their prostatectomy, or if you have any reason to suspect that they have more scar tissue, you need to counsel them that there is a high chance of having an issue. Those are the patients that I worry about the most.

Urology Times: What innovations in adjustable continence technology would meaningfully improve outcomes for patients?

Sury: The adjustable option with no patient input, ProACT itself, is going to be a big new option. I think more surgeons are going to learn how to do it. It’s another option, [which] is great for patients.

When I look further on the horizon, though, another game changer I think is going to be the electronic artificial sphincter. One of the biggest barriers to patient uptake [with the conventional artificial sphincter] is they don’t like the idea of having to squeeze a button every time they have to pee, or maybe [they have dexterity issues] or other reasons. They are running a trial in the US [on the electronic artificial sphincter]. They’ve been doing it in France, and now they brought it over to America. One of my mentors from my fellowship, Dr. [Andrew] Peterson, is leading that, and so I’m very excited to see how that goes.

I think the possibilities once you add electronics to it [are wide open], the idea of a sphincter that auto-senses [pressure] and opens up automatically. Or maybe it relaxes at night when you don’t have to worry about leakage so much, so it’s not squeezing 24/7, and maybe that reduces atrophy rates or erosion rates.

One of our biggest fears is always [that] a patient with a sphincter ends up in the ER, and they put a catheter in, and that’s how you get an erosion, and then [you] have to remove that. One of the nice things with ProACT is that the sphincter cuff is a fixed ring. It can only expand so far, but the balloons aren’t fixed, so they say that you can leave catheters, you can do cystoscopy, you can put larger cameras in, and the balloons ought to move out of the way, which should reduce your risk of causing an erosion or injuring the device with long[-term] use.

I think adding electronics to all of this is very unique, and I hope the electronic artificial sphincter is on the market [and] commercially available in the next 10 years. Ten years is a long time to wait when you’re incontinent and in diapers daily, so that’s why I’m happy that we have slings, regular sphincters, and now ProACT [as] another option for those [patients] who are suffering now.

____

REFERENCES

1. Breyer BN, Kim SK, Kirkby E, et al. Updates to Incontinence After Prostate Treatment: AUA/GURS/SUFU Guideline (2024). J Urol. 2024. doi:10.1097/JU.0000000000004088

2. Nestler S, Thomas C, Neisius A, et al. Long-term results of ProACT primary and repeat implantation for treatment of stress urinary incontinence in men. World J Urol. 2019;37(6):1173-1179. doi:10.1007/s00345-018-2483-4

3. Kong L, Coodington ND, Flynn BJ. Secondary placement of adjustable continence therapy (ProACT™) using open perineal technique: Case report of ProACT placement in a man with a devastated urethra following pelvic trauma and multiple AUS erosions. Urol Case Rep. 2023:49:102424. doi:10.1016/j.eucr.2023.102424