Dr. Sadeghi-Nejad discusses penile prosthesis surgery

Hossein Sadeghi-Nejad, MD, FACS

In this interview, Hossein Sadeghi-Nejad, MD, FACS, summarizes the 2024 American Urological Association Annual Meeting panel discussion “Tricks and Tips of Penile Prosthesis Surgery” and also shares insights on penile implant surgery. Sadeghi-Nejad is a professor of urology at New York University (NYU) Grossman School of Medicine, professor of obstetrics and gynecology at NYU Grossman School of Medicine, and director of Mens Health, Urology at NYU Grossman School of Medicine.

Could you provide some takeaways from the 2024 AUA panel discussion “Tricks and Tips of Penile Prosthesis Surgery”?

The AUA has [many] different sessions on implants and various urological issues. This one, I would say, was designed for the more experienced implanters and also to deal with some of the problems that prosthetic surgeons can encounter; hence, the title, “Tricks and Tips of Penile Prosthesis Surgery.” Of course, a lot of the issues that were discussed are equally relevant to somebody who is just starting. But I would say the vast majority of the topics and the slides of our various speakers were geared toward the more experienced implanters and then some of the problems that prosthetic surgeons can encounter. One of the sort of corollaries to what I just said is that we were hoping that by seeing these presentations, the experienced implanters would hopefully learn something new. And then the inexperienced implanters would have a better sense of not only what cases to do and what to do, but also what not to do, and what cases to refer. That, to me, was an important part of this presentation.

My own brief overview of the whole talk started by going back to a session that I moderated at the AUA Advocacy Summit in late February. That presentation had been geared toward urological cancer survivors, and our session was about the benefits of prosthetics in that particular group. One of the things that I highlighted was our own work together with Penn State Cancer Institute and Dr. Chan Shen, where we looked at the SEER Medicare database between 2006 and 2011, and [identified] more than 30,000 prostate cancer cases, of which a little more than 10,000 had undergone radical prostatectomy and a little more than 20,000 had had radiation therapy. Of that cohort, there were about 44% who were diagnosed with erectile dysfunction. That's close to 14,000 patients who were diagnosed with erectile dysfunction, and yet in that group, only 2.5% percent were treated with implants. And that was understandably higher in the radical prostatectomy group, because that's a group that's primarily handled by urologists, and 1.4% of the radiation group. But the big-picture message of that slide was that, in general, penile implants appear to be very underutilized. There are a lot of different reasons for that on the part of the patients. Obviously, it's not something that the average cancer patient is aware of or knows of. They may be told by their cancer surgeon that erectile dysfunction and urinary incontinence are some of the sequelae of cancer surgery, but they may not necessarily go into the details of what options are available. Doing rehab of the penile rehabilitation protocols, which typically involves, let's say, the PDE-5 inhibitors like Cialis or Viagra, as well as possibly vacuum devices and injections. If the patient fails those, then it's not an automatic that the cancer surgeon will say, "You can also consider penile implant surgery," or, "let me send you to one of our colleagues that is an expert in this area." Now, in academic centers, that exists, but perhaps in a smaller practice, that expertise may or may not be there. And then, of course, on the part of the surgeons, some of the reasons for the low numbers may be complexity of some cases. If you are dealing with a [patient with] prostate cancer who has radiation, are you concerned about the difficulty of putting in an implant if they have had a robotic prostatectomy? Are you concerned about where to put the reservoir? And then of course, there's the issue of payments for prosthetic cases, which are arguably very technical; I don't want to say "complex." A standard virgin case is not necessarily complex, but the payments in general are very, very low, and so some surgeons have unfortunately shied away from doing these cases.

With that big picture in mind, we had designed this session to bring in experts from all over the country, some of the most recognized folks in the field, to talk about some of the various issues that can be involved. Dr. Amy Guise, from the Medical College of Wisconsin, talked about the safest options for placement of the reservoir. In other words, I just mentioned, for example, the [patient with] prostate cancer who's had a robotic prostatectomy. More and more surgeons are not comfortable putting that reservoir in the traditional retropubic space, and they place these implants in, let's say, a sub rectus position, or what we call an ectopic position, which is another term basically for when it's not the space of Retzius, which was the classic space that was used. There are, of course, a lot of technical details that come into consideration. How do you get to that space? How deep do you go before you advance your reservoir to the ideal placement? Do you put it laterally; do you put it in the middle? And then of course, [there is] everybody's nightmare in terms of implant surgery. No matter how good a surgeon you are and how careful you are doing these cases, we know that there are going to be infections. What are the best options when dealing with an infected implant? The take-home message that I had from Dr. Charles Welliver's presentation was that you have to use your judgment and decide which patient can be a candidate for what we call salvage surgery, which is basically when you take out the infected implant, and you put in a temporary device. One option is to put in a temporary device, meaning, let's say, a malleable device, and then go back down the line if the patient wants to go back to an inflatable or sometimes they may keep the malleable and be happy with it. The alternative is sometimes you could actually do a salvage by putting in an inflatable device right there and then. But it appears that when you go for the malleable as an interim measure, the infection rates are a little bit lower. But that's a repeat infection basically. But I think the important take-home message from his talk also is to decide what patient should not be offered a salvage procedure, and that's a patient who has sepsis, who has tissue necrosis. In those cases, you're almost guaranteed to have a failure and then have to go back and take it out. If you can do a salvage procedure, you have the advantage of preserving length, because one of the issues that happens is that when you take out an infected implant and you wait, if you don't have a sort of a space saver in the interim, the vast majority of these patients will experience girth and length loss. So if you can temporize it by putting something in there, you have the advantage of not experiencing that length loss, but you have to [consider], I have this patient who's already had a devastating side effect. Do I want to do something where, in 2 weeks, they're going to have another infection, and then I have to go back and take out the second device that I put in? Or do I want to take everything out, wait 3 months or however long I decide to wait, before putting in a new implant? I would say that from a safety standpoint, there is no question that it is safer to take everything out, and then wait. But then I think the art of the prosthetic surgeon, more than the science, or perhaps a combination of the art and science, is to decide, what are the cases that can be salvaged. We know that the vast majority, more than 60% to 70%, can be salvaged in experienced hands. But then it's those critical cases that really are not candidates for salvage.

Then Dr. Petar Bajic from the Cleveland Clinic talked about you deal with length loss following an infected implant removal. This is something that has been my practice for the last at least 15 years, and that is that if I have removed an implant, I insist on the patient using a vacuum device, which is an externally applied device, basically, to keep that space as open as possible. What I found is that by doing that, I seem to minimize the length loss. [In addition], I make the process of putting in that second implant when there has been that, let's say, 3-month interim period, where everything inside gets scarred and fibrotic, a lot easier. And I would say the most important part of Dr. Bajic's talk was, again, to emphasize the importance of that temporizing measure to make the re-do surgery easier. And then the next 2 talks, were truly, I would say, for the experienced implanter. These are cases that really should not be attempted by new implanters. The talk from Dr. Jonathan Clavell from Clavell Urology—he's associated with the University of Texas at Houston—was what we called rerouting procedures for impending erosion—the implant that basically has almost come through, whether it be the urethra or whether it be the lateral part of the corpus cavernosum through the tunica. How do you deal with that? He very eloquently showed techniques whereby you can essentially pull back the implant that's about to erode and then reroute it through a safer passage to a location where the extrusion and erosion would not occur. As I said, these are not easy cases to attempt, and they definitely should be referred.

Last but not least, we had Dr. Steven Wilson. In my plenary talk, I introduced him as the "prosthetic surgeon's prosthetic surgeon." He is the person who is really responsible for simplifying so many steps in prosthetic surgery, and making it standard both for virgin cases and re-do cases. He was a mentor to me, in that I was very fortunate when I started my practice in New Jersey, he visited me and he spent a week with me and we operated both at the VA and at Hackensack University Medical Center at the time. I learned a lot of these techniques for dealing with a corporal fibrosis. That's the process that I told you happens when you remove an implant; the inside of the penis becomes like cement, like scar tissue and how do you chisel your way through that scar tissue? There are really 2 main scenarios where we see that, and 1 is after these infected implant removals and the other group of patients that experience that are patients with priapism. And so Dr. Wilson very expertly talked about the use of what he really popularized as the tunnel technique; instead of making a huge corporotomy and filleting the whole penis, he basically taught us to use these dedicated instruments called cavernotones to gradually and gently chisel away that scar tissue and make room for the implant. Again, this is not something for inexperienced implanters because it is very easy for that scar tissue not to dilate, but rip, and it could rip toward the urethra, it could rip outside the tunica. So again, this whole presentation was about management of corporal fibrosis. And it was all about using thosesame standard techniques that we use in virgin cases that Dr. Wilson popularized and simplified for many, but also for use of specialized instruments to do what's called a tunnel technique, because with a tunnel technique, some of the complications that are seen with other approaches, including ischemia of the glans and the penis, are almost completely avoided.

Are there any emerging technologies or advancements in implant design or surgical techniques that you see as particularly promising for improving patient outcomes or expanding candidacy for penile implantation?

I think all the major implant companies are constantly improving the devices. There's been sort of this timeline of improvements over the past 20 to 30 years:the antibiotic-coated device from Boston Scientific, the hydrophilic-coated device from Coloplast. Basically, these devices come either antibiotic coated, or they have this lining that allows you to choose the antibiotic to then adhere to the implant and reduce infection rates. There have been a number of changes in pump design to make it easier for patients to activate and deactivate the implant. That's been evolving, and they are all coming up with newer and newer versions.

For a long time, there has been talk of remote-controlled devices. This goes as far back as even when I was doing my fellowship back in 1996. The technology is there now; whether they first come up with a version for artificial urinary sphincters or the implant is anyone's guess. There was actually a very interesting talk at the Sexual Medicine Society of North America. It was a debate on the pros and cons of having these remotely activated devices, where 1 person was saying it's great because it avoids a lot of the pump problems. The other person was saying that if you look at the cardiac literature and some of the complications that we see from defibrillators and from devices that are put in for patients; for example, for atrial fibrillation, and the battery problems and then the skin effects. That is an emerging field.

The other thing that is evolving is we have moved more and more toward doing increasing numbers of reservoir placements in the ectopic space. But I would say that is an area that is still in need of improvement. It has not become a universally accepted technique. There are many different variations of this technique. In some ways, it is easier, because you avoid the retropubic space. In some ways, it is more difficult because these ectopic reservoirs can herniate down because they're not really going deep in the body; they're going under the muscular layers. And as the patients move around, they can have a higher chance of herniating down, they have a higher chance of rotating and causing what we call a telephone cord phenomenon where they stop working. So there are a lot of issues still with that that are being worked on.

And then, of course, there is never enough work done to try to minimize infections. It's still not 0. We have made a huge, huge improvement with these hydrophilic-coated devices and antibiotic-coated devices. But we're still not infection free. Nor are, for example, the orthopedic surgeons, where, for them, the implant infections in bone have even more devastating consequences. That's an area where we could still get some work done.

Could you talk about some of the most common long-term complications associated with implants and how you recommend managing them?

Long-term complications, really, once you're past that first, I would say, 6- to 8-week period of infections, are uncommon. Of course, now with these antibiotic-coated devices, as well as the hydrophilic-coated devices, we're seeing later emerging infections, because a lot of the common bugs have been not as effective infecting these devices, essentially. But the other complications, meaning device erosion into the bladder, are exceedingly rare. The main things that we talk about are really mechanical malfunction, [but] if you go out about 10 years, you'll see that more than 80% of these devices are still working. So reliability is very high. It's arguably one of the most reliable, if not the most reliable prosthetic devices used in human bodies. They're very, very reliable. The other complications - vascular injuries, organ erosion - those are exceedingly rare.

What factors influence your selection of an implant for a particular patient's needs and lifestyle?

I think the big choice is between a malleable and an inflatable, and patients who have dexterity issues, who will have difficulty inflating and deflating the pump or activating and deactivating the pump, I think those are patients who are better served with malleable devices. But that's a smaller device. I think malleable devices are not optimal for patients with Peyronie disease. That's part of the guidelines for Peyronie disease. I was actually part of the guidelines, and we recommended that if you're going to use the implant to correct Peyronie disease and erectile dysfunction at the same time where you're going to be doing these adjunctive procedures like manual modeling or incision and grafting, I would say, especially for the modeling procedure, the inflatable devices are better. You can do better modeling with an inflatable device than a malleable device. The malleable device is of course preferred over the inflatable when you're using it as kind of that space saver for these salvage cases because there are fewer components. There's less tubing, there's nothing in the scrotum. Most of the infections happen in the scrotal area. So when you can get rid of that pump and buy some time, the malleable device is certainly better as a space saver. And then some patients may decide that they want to stay with it and they don't have to change to an inflatable device.