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Utilizing XIAFLEX for Peyronie’s Disease

Author Devante Delbrune covers Utilizing XIAFLEX for Peyronie’s Disease on BackTable Urology

Devante Delbrune • May 19, 2023 • 467 hits

XIAFLEX injections for Peyronie's disease can offer up to a 30% improvement in the degree of curvature and should be paired with a penile traction therapy device (e.g. RestoreX). Peyronie’s disease is a common condition affecting men in which scar tissue accumulates in the penis and causes painful, curved erections. Patients with the condition are classified based as either acute or stable depending on the phase of the disease. For acute patients, XIAFLEX injections for Peyronie's disease is a heavily popularized treatment option. Dr. Silva and Dr. Clavell discuss the diagnostic and categorization criteria for Peyronie’s disease, as well as indications and candidacy for XIAFLEX.

This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, and you can listen to the full podcast below.

The BackTable Urology Brief

• Peyronie’s disease has a variable presentation, is often associated with erectile dysfunction, and is typically diagnosed via medical history and physical exam.

• Peyronie’s disease patients are categorized as either acute or stable phase based on symptom duration. Less than three months of acquired penile curvature places a patient in the acute phase, while more than three months of dysfunction places the patient in the stable phase.

• XIAFLEX injections for Peyronie's disease, which softens plaque calcifications, can offer up to a 30% improvement in the degree of curvature and should be paired with a penile traction therapy device (e.g. RestoreX).

• The XIAFLEX injection is recommended for patients with erectile function (well-managed by medication), non-calcified plaque (acute phase), and/or a high degree of bother.

XIAFLEX injection being loaded for treatment of peyronie’s disease

Table of Contents

(1) Peyronie’s Disease Patient Presentation and Overview

(2) Peyronie’s Disease Categorization

(3) Utilizing XIAFLEX for Peyronie’s Disease

Peyronie’s Disease Patient Presentation and Overview

Peyronie’s disease (PD) is a condition in which a fibrous scar tissue develops on the penis, resulting in penile curvature. It has an extremely variable presentation exhibiting differing deformities, curvatures, and penile shortening, and can present with or without pain. This condition may be associated with difficulty maintaining an erection sufficient for satisfying sexual activity or general erectile dysfunction (ED). Due to this variability, treatment should be individualized to the presenting patient. Diagnosis of PD is typically clinical, with history notable for an acquired penile deformity with or without penile pain.

[Dr. Jonathan Clavell]
The most common referral that I get from other urologists is to help treat Peyronie's disease. Peyronie's like many other conditions are extremely variable and there are so many different ways in which a patient can present. There are many types of deformities, distal curvatures, proximal curvatures, hourglass deformity, corporeal wasting, penile shortening, pain, no pain. The same way we do not treat every stone case or BPH case is the same way. With Peyronie's disease, the treatments should be individualized.

When it comes to patient presentation, when a patient presents to my office for a complaint of Peyronie's disease, first of all, I listen. I try not to book more than two new Peyronie's patients in one day because I know they will take a long time to counsel. These patients are extremely distraught, they're frustrated, they're anxious. Think about it, their penis was perfectly fine and most of the time, all of a sudden, without a clear injury or without them even knowing why their penis started changing. Let's be honest, it is not easy to talk about these things to a stranger.

There's actually been research on this and most men take years, again years, before they seek treatment. The least we can do is listen to them. I believe Peyronie's disease is a lot more common than we think. Men with Peyronie's, for me, I always tell people it's like men with Peyronie's are just hiding in caves. They're scared, they're ashamed, they push their partners away, and they do not even know that it can be fixed. I listen, I examine them, and I try to explain everything. My practice is very different from many urologists. Most of the men that I see are already in the stable phase.

They have seen either one or two other doctors, be it their primary care doctor, they refer them to a urologist. Urologists didn't know what to do with them or it was too complex for them to manage and they at least have an idea of what's going on. Regarding the acute versus stable phase, we need to remember that the guidelines have changed from several years ago. I still remember being in residency. When I was in residency, you had to cram down a clinic of 50 patients.

Seeing a patient with Peyronie's, it was the greatest thing because, at that time, when I was a resident, I still remember we had to wait one year without any changes before considering treatment. Whenever the patient presented, I always ask them, so how long have you had the curvature, or when was the last time you noticed a change? If they told me, "Doc, it was three months ago," I'm like, "Okay, well, great, I'll see you in nine months." Then we go on to the next patient. Those conversations tended to be very quick. Now, it's very different.

Now, we considered the stable phase when they have had no changes within three months. I always ask them, "When was the last time you noticed a change?" If they have a picture, I ask them, "How long has your penis been like this? Has it changed?" We need to know these things as it may change our treatment algorithm a little bit. Right now, it's very important that we remember that it's only three months before a change for us to consider it to be within the stable condition.

[Dr. Jose Silva]
Pain is no longer a determinant in that sense? It's just the change in angulation.

[Dr. Jonathan Clavell]
That's very interesting because, again, patient who presents with penile pain, first of all, penile pain alone is not considered Peyronie's disease. Pain in the penis can be secondary to infection. It can be potential nerve entrapment, it can be pelvic floor dysfunction. There are so many things that can be causing penile pain. However, when you have pain in combination with an acquired deformity, it can be considered Peyronie's. Another thing we need to remember is that, just like you're saying, pain is a subjective complaint.

There recently was a debate on Twitter regarding a review article published by the Mayo Clinic, in which they were discussing the inconsistencies in the literature when it comes to differentiated acute versus chronic disease. Pain is one of the things that is considered inconsistent. Why? Because pain is objective. Many men can have stable curvature or deformities for months or even years but if they also have a good, strong erection, that scar tissue will start tethering on that erection, that tunic albuginea, and the patient can complain of pain. The other thing that I also take into consideration is, are we talking about pain or are we talking about them having discomfort? Again, with Peyronie's disease, the scar tissue is not allowing the penis to stretch out to its full capacity, therefore, if you have a patient who has a strong erection and that scarred tissue is holding the penis back, it will at least be uncomfortable. Not a reliable indicator at least for me.

Listen to the Full Podcast

Peyronie's Disease Challenges and Solutions with Dr. Jonathan Clavell on the BackTable Urology Podcast)
Ep 72 Peyronie's Disease Challenges and Solutions with Dr. Jonathan Clavell
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Peyronie’s Disease Categorization

Upon presentation, patients with PD are categorized based on the phase of their condition (acute vs. stable). Acute phase patients are those who have had an acquired penile curvature for less than three months, but after the three month mark, they are considered to be in the stable phase. Previously, patients were only treated once categorized as “stable” since pain may improve once the plaque has stabilized; however, this is no longer the case. Initial treatment now depends on pain and presence of ED. For pain management, initiation of NSAIDs is first line. Some physicians have utilized low intensity shockwave therapy as well, but results as to its efficacy are currently unclear. For management of ED, Dr. Clavell prescribes a phosphodiesterase type 5 (PDE5) inhibitor, and once the plaque stabilizes, switches to Tadalafil (5mg) mixed with water.

[Dr. Jose Silva]
Those patients in the acute phase, prior to seeing them again in three months, do you do anything to them? Any pills, anything, or just tell them, try to cancel, and say, "Hey, we need to wait"?

[Dr. Jonathan Clavell]
No, it depends on where, how bad the curvature is. It depends on their state of their erection. It depends on their age, their comorbidities. It depends on also the how quickly they really want to get to a solution. If they have pain, I just give them pain control, NSAIDs, Tylenol, there's some studies right now suggesting that low-intensity shockwave therapy, again, not radial wave therapy, but through linear shockwave therapy could help. However, according to guidance, the pain sometimes, most of the time, it actually improves once the plaque stabilizes.

I always wonder if the shockwave really helped or was it just time that helped the pain. Now, they're saying that the shockwaves the one that helped them out. However, who knows what happens? Then if they have erectile dysfunction, I will give them medications for erectile dysfunction. PDE5 inhibitors. There's been some doctors mostly in Europe that say that their patients do well and that the plaque stabilizes better if they are on daily Tadalafil. I don't believe that's true. It was only like one doctor talking about that .I am one that I believe that a daily Tadalafil should be in water. We call it vitamin C or vitamin Cialis. Again, it's a great medication, low dose, it can help them bring blood flow into the penis. There's actually been some studies suggesting, again, don't take that as scripture, but there are some studies suggesting that it can actually, even that medication Tadalafil has anti-inflammatory properties. It's something that I give during the acute phase and sometimes even after surgery to help them recover quicker.

[Dr. Jose Silva]
Good to know that. The 5 milligrams or you go to 2.5?

[Dr. Jonathan Clavell]
I go five milligrams daily. I think I prescribe that at least 10 to 15 times every day.

Utilizing XIAFLEX for Peyronie’s Disease

XIAFLEX injections for acute Peyronie's disease may be a suitable treatment option. XIAFLEX is an injectable therapy of collagenase clostridium histolyticum that softens plaque calcifications. Candidacy is based on the presence of well or adequately medication-managed erectile function, the presence of non-calcified plaque, and a high degree of patient bother. It is important that the plaque is non-calcified, as injections are performed by inserting an insulin needle directly into the plaque. Another limitation is insurance coverage, as the treatment is quite expensive out of pocket. Patients that get XIAFLEX for Peyronie's disease can expect around 30% degree of curvature improvement according to the IMPRESS trials. This improvement increases when paired with a penile traction therapy device, of which Dr. Clavell recommends the RestoreX device. Of note, for patients requesting treatment for aesthetic purposes, such as hourglass curvature correction, Dr. Clavell recommends utilizing XIAFLEX in conjunction with sub-dermal fillers.

[Dr. Jose Silva]
Let's talk about the XIAFLEX injections for Peyronie's disease and other injections. When do you use them? When you start using them? At what point during the stage of the Peyronie's you use them?

[Dr. Jonathan Clavell]
The limiting factor for using XIAFLEX injections within the acute phase, there's actually been studies comparing acute phase, using XIAFLEX, acute versus stable. They actually respond during the acute phase but the limiting factor is the insurance company. Insurance companies will find whatever excuse to not approve this medication. I mean this medication is a little bit expensive, at least for a patient who's paying out of pocket. When it comes to offering these injections, I truly believe they can work.

However, when it comes to choosing which treatment to offer, the most important thing to remember is this. As I tell them, I start off to every patient, I tell this sentence, "We only treat Peyronie's depending on two things. Your degree of bother and the degree of erectile function." I will repeat that. Degree of bother, not the degree of curvature, but degree of bother and the degree of erectile function. A man who has good erections and is not bothered, we leave alone. For example, I've had guys who have almost 60-degree ventral curvature and they call me and we've had even virtual visits and they're like, "Hey, doc, I'm not sure, this started happening." I asked, "Are you able to have sex?" "Yes." "Does your wife complain?" "No." "Do you complain?" "Well, I just want to make sure that, I'm not going to develop cancer or something like that." Then I asked him, "Does it bother you?" "No." "Well, just leave it alone if you're able to have sex." He's like, "Oh, well, great, doc, that's what I want to know."

Sometimes you will have a guy who has a 30-degree curvature or sometimes even a 20-degree curvature and you're like, "I think my penis might curve more than yours." He wants it fixed. Again, it all depends on the degree of erectile function and also the degree of bother, not the degree of curvature. That's the most important thing. Then depending on those two things, I start offering treatments. Then the other things that we have to take into consideration is, for example, is the plaque calcified? Does the patient have hourglass deformity? Do they only have a curvature? Do they also have erectile dysfunction? Do they have an unstable penis? Are they in a hurry to fix it? Do they want to be functionally straight or they want to be straight like an arrow? Those are the things that we really need to take into consideration and make sure that we address those questions. Because again, these treatments are not for life or death. We're talking about quality of life. When it comes to a penis, a man who wants their penis to look good, right? We want to make sure that one we set up proper expectations.

Number two, we offer them something to meet those expectations, if we're able to get there. The only injectable therapy right now that I currently use is XIAFLEX. I offer it to patients with a curvature and a plaque that is not calcified, and have good erectile function. There is some data for the use of interferon and verapamil. The only one that I'm using at the moment is XIAFLEX. Again, I use it for those with good erection and a curvature. If they have ED that is not responding to pills, they need an implant.

Then the other thing is regarding calcified, versus noncalcified, a plaque that is calcified in my opinion is unlikely to respond to the medication. Why? Whenever we use XIAFLEX injections, we need to inject the scar, not around the scar. The XIAFLEX injection that is injected, we're usually using an insulin needle, which is very unlikely to go into a calcified scar. Whoever's injecting, we should be able to, first of all, identify and feel the plaque, he or she who's injecting, we should probably be struggling when we're injecting.

I tell guys, "If I go in and goes like whoop," super quick, is very unlikely that I injected at the right spot. I try to emphasize this whenever I do trainings for-- I'm a speaker for XIAFLEX injections for Peyronie's disease. For example, I tell that to practitioners, and the providers who are using these injects, what we need to make sure that we struggle, otherwise, we're not really injecting in the right spot.

[Dr. Jose Silva]
Jonathan, in terms of that calcified plaque, is it based on ultrasound, or just on palpation?

[Dr. Jonathan Clavell]
Most of the time, it's with ultrasound. However, there will be some guys that as soon as you start pulling on that penis and you touch it, you know that's like a rock. For those, I tell, "Hey, man, XIAFLEX is really not going work for you." Again, the other thing that I wanted to mention, now that we're talking about XIAFLEX, is that we need to remember what the research shows. XIAFLEX injections in the pivotal studies, which were the IMPRESS Trials that showed 30% improvement in degree of curvature.

If you have a patient who has a 60- degree curvature, expect to get down to about 45 degrees, 30% improvement. If you have a patient who has a 90-degree curvature, you have to explain to the patient, "Don't expect your penis to be spread like an arrow." Most of the time, the XIAFLEX alone might not do the job, but it can be done with penile traction. To be honest, I am not a huge believer in XIAFLEX alone, I am not a big believer in traction therapy alone, but both together, I've seen men go from an almost 90-degree curvature to almost 30-degree curvature, which many men consider it to be functional.

Again, if there's anybody, any urologist listening to me, when it comes to XIAFLEX injections, we need to make sure that these patients are doing their rehab at home. The XIAFLEX will only soften that scar tissue, but the real homework needs to be done by the patient. They are the ones who has to be doing those regular exercises at home. The good thing about this RestoreX device, and again, just in case I have no stock in RestoreX. Again, it is a device that can actually help men. There's been good research showing that sometimes it can be more than 50% improvement when you combine both RestoreX with the XIAFLEX injection for Peyronie's disease.

Podcast Contributors

Dr. Jonathan Clavell discusses Peyronie's Disease Challenges and Solutions on the BackTable 72 Podcast

Dr. Jonathan Clavell

Dr. Jonathan Clavell is a high-volume prosthetic urology surgeon and assistant professor of urology at UT Health Science Center Houston.

Dr. Jose Silva discusses Peyronie's Disease Challenges and Solutions on the BackTable 72 Podcast

Dr. Jose Silva

Dr. Jose Silva is a board certified urologist practicing in Central Florida.

Cite This Podcast

BackTable, LLC (Producer). (2022, December 28). Ep. 72 – Peyronie's Disease Challenges and Solutions [Audio podcast]. Retrieved from https://www.backtable.com

Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.

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