Peyronie's disease treatment with Xiaflex

Peyronie's treatment with experimental drug, Xiaflex

Peyronie’s disease is best known for the plaque, scar or hard lump that causes a curved penis to develop. Peyronies begins as a localized inflammation, usually as a result of injury of some type. It is currently believed that Peyronie’s disease is caused by vascular trauma or injury to the deeper penis anatomy. Peyronie’s disease is most common in men over 50 years, and the incidence increases with age. This inflammation often progresses to a hardened plaque or scar that reduces flexibility of the tissue of the penis, and results in a bend or distortion during erection due to incomplete filling or restriction of the tissue. Often, this causes constant pain or pain during erection, and for some men these can prevent sexual intercourse due t physical incompatibility or erectile dysfunction.

Aside from the physical changes, depression and reduced self-esteem are commonly experienced by men with Peyronie’s disease.

Peyronie’s disease is most often treated by urologists, even though there are no approved drug therapies for Peyronie’s disease. Peyronie's surgery may be an option for some patients although complications such as worsening of the PD distortion can develop, as well as loss of penile length can occur. Xiaflex, a type of collagen reducing enzyme, or collagenase, has been experimentally injected into the Peyronie’s disease scar or plaque as an in-office procedure. The purpose of injecting Xiaflex into the Peyronie's disease scar is to soften the scar tissue and improve or reduce the curvature of the penis. Further, this is hoped to improve sexual function and eliminate the distressing negative psychosocial aspects of Peyronie’s disease.

Peyronies Xiaflex trial results

Sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, the 12 month phase II open-label trials of Xiaflex showed limited but promising results. These research tests were conducted to evaluate the ability of Xiaflex to successfully treat Peyronie's disease, as well as its compatibility and side effect potential. In this process clinical success was defined as a baseline change of penile angulation of at least 25 percent.

Each of the study participants received three injections of Xiaflex, administered on a separate day, and given over seven to ten day period. Twelve weeks later, each man received a second series of three injections. Research subjects were evaluated at three, six, and nine months after the Xiaflex injection series.

The average baseline angulation was 52.8 degrees. In this study clinical success was achieved at three and six months with 58 percent and 53 percent of patients, respectively. This would suggest that early success might not last very long or that the improvement to the Peyronie’s disease distortion was temporary.

In this study there were adverse reactions with Xiaflex that were not described in the general media. The most common adverse reaction was only reported as a problem at the local administration site that was mild or moderate in severity, non-serious, and resolved in time without medical attention. No comment was made about worsening of the Peyronie’s disease after the nine month time frame as a direct result of repeated injury to the delicate tunica albuginea tissue from the multiple needle injections of the needle used to deliver the Xiaflex.

It is the opinion of PDI that for some men these repeated injections could make their Peyronie's disease condition worse over time. It might be prudent for the average man to wait until more clinical treatment results are collected and interpreted before considering this treatment approach.

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Peyronie’s disease treatment with Xiaflex

Peyronie’s treatment with experimental drug, Xiaflex

Peyronie’s disease is best known for the plaque, scar or hard lump that causes a curved penis to develop.   Peyronies begins as a localized inflammation, usually as a result of injury of some type. It is currently believed that Peyronie’s disease is caused by vascular trauma or injury to the deeper penis anatomy. Peyronie’s disease is most common in men over 50 years, and the incidence increases with age. This inflammation often progresses to a hardened plaque or scar that reduces flexibility of the tissue of the penis, and results in a bend or distortion during erection due to incomplete filling or restriction of the tissue.  Often, this causes constant pain or pain during erection, and for some men these can prevent sexual intercourse due t physical incompatibility or erectile dysfunction.

Aside from the physical changes, depression and reduced self-esteem are commonly experienced by men with Peyronie’s disease.

Peyronie’s disease is most often treated by urologists, even though there are no approved drug therapies for Peyronie’s disease.  Peyronie’s surgery may be an option for some patients although complications such as worsening of the PD distortion can develop, as well as loss of penile length can occur.   Xiaflex, a type of collagen reducing enzyme, or collagenase, has been experimentally injected into the Peyronie’s disease scar or plaque as an in-office procedure. The purpose of injecting Xiaflex into the PD scar is to soften the scar tissue and improve or reduce the curvature of the penis. Further, this is hoped to improve sexual function and eliminate the distressing negative psychosocial aspects of Peyronie’s disease.

Peyronies Xiaflex trial results

Sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, the 12 month phase II open-label trials of Xiaflex showed limited but promising results.  These research tests were conducted to evaluate the ability of Xiaflex to successfully treat Peyronie’s disease, as well as its compatibility and side effect potential.  In this process clinical success was defined as a baseline change of penile angulation of at least 25 percent.

Each of the study participants received three injections of Xiaflex, administered on a separate day, and given over seven to ten day period.  Twelve weeks later, each man received a second series of three injections.  Research subjects were evaluated at three, six, and nine months after the Xiaflex injection series.

The average baseline angulation was 52.8 degrees.  In this study clinical success was achieved at three and six months with 58 percent and 53 percent of patients, respectively.  This would suggest that early success might not last very long or that the improvement to the Peyronie’s disease distortion was temporary.

In this study there were adverse reactions with Xiaflex that were not described in the general media.  The most common adverse reaction was only reported as a problem at the local administration site that was mild or moderate in severity, non-serious, and resolved in time without medical attention.  No comment was made about worsening of the Peyronie’s disease after the nine month time frame as a direct result of repeated injury to the delicate tunica albuginea tissue from the multiple needle injections of the needle used to deliver the Xiaflex.

It is the opinion of PDI that for some men these repeated injections could make their Peyronie’s disease condition worse over time.   It might be prudent for the average man to wait until more clinical treatment results are collected and interpreted before considering this treatment approach.

Peyronie’s disease therapy and a little more

Additional Peyronie's disease treatment to consider

One of the best questions you can ask yourself during your Peyronie's disease therapy is, “What else can I do to help this problem along?”

The answer does not always have to mean a great amount of money spent on more supplements and enzymes – although this is not a bad idea, either.  You can:

1.      Apply moist heat to the scar area.

2.      Take more time and effort to assure you are not compressing your genital when you are sitting.

3.      Make some of the simple and easy dietary changes that PDI suggests to increase your odds of recovery. from Peyronies.

4.      Spend more time in intercourse or masturbation to increase circulation to the genitals.  How this should be done is a major topic of my second book, “Peyronie’s Disease and Sex.”  For more information see “Peyronie’s Disease and Sex”

5.      Consider using some simple massage and exercise procedures that will increase blood flow in and lymphatic drainage away from the area. An excellent way to do this is explained in the one-hour instructional video from PDI at Peyronie's Disease Massage and Exercise Video.

6.   Start a program of gentle manual penis stretching to reduce the soft tissue contraction and fibrous infiltration of the fibrous scar.   Look at the information about this stretching concept, at Peyronie's Disease Manual Penis Stretching.

7.  Learn how to evaluate your situation as a scientist might so you will know for a fact – better than your MD – the exact condition of your PD scar.  Once you know how to evaluate your situation you are far more likely to identify improvement when it occurs.   All of this is covered in the first book about PD I wrote, “Peyronie’s Disease Handbook.”   For more information see “Peyronie’s Disease Handbook”

8.      Get more physically active with walking and light exercise, and spend less time sitting in front of the TV.  Anything you do to increase your level of physical activity will boost your immune response and chances of recovering from Peyronie's disease.

9.     Ask questions if you do not know how to help yourself.  Write an email and explain your situation, and I would be happy to help you in whatever way I can.

Don’t be a victim to Peyronie's disease.  Take action.  Learn to be in control of it and you are closer to victory over your PD.

Peyronie’s disease treatment and melanoma

Although this is not the usual kind of information I enter on the Peyronie’s Disease Treatment Forum, it is important to discuss because the cancer  information you will read is important for any age audience, especially with the large number of seniors who are registered.

Even though this is not totally a Peyronie’s disease topic, there is a strong PD message at the end.

If only Peyronie’s Disease was this easy to figure out

A little over a year ago, my wife asked me about the black mole on the back of my left shoulder.  As in many of my conversations with her, I replied, “Huh?”

Twisting and stretching around, I examined myself in the mirror.  To my surprise I saw a flat black mole, slightly oval and right at ¼ inch across, that seemed to have come up overnight.  Good grief, Peyronie’s disease audience, what does that remind you of?

I knew that this flat black mole had the potential to become a melanoma, a malignant skin cancer, so I was concerned.

Melanoma skin cancer facts

The primary sign of a melanoma is any change in size or color of a mole or other skin growth, such as a birthmark.   A melanoma may even grow within a mole or birthmark that you already have, but they usually grow in previously normal and unmarked skin anywhere on the body.  Most often, they appear on the upper back (like mine) of men and on the legs of women.

Melanoma usually looks like a flat, brown or black mole with uneven edges, and  an irregular or asymmetrical shape.  When a melanoma is irregular or asymmetrical, one half of it doesn't match the other half. Mine was nicely even or symmetrical.   Melanoma are not small, meaning they are usually in the larger range of those funny things that sometimes appear on the skin, ¼ inch or more.

However, I knew that a melanoma in its very early stage can look like a mole.

Moles are harmless skin growths that can be either flat or elevated in one or more areas.   The color of a mole can vary from pink flesh to dark brown or black.  The number of moles that a person has depends on the genetic nature of the person and the amount of sun exposure during childhood. I was in the sun a lot; getting at least one or two bad bouts of sunburn was just something that seemed to happen most every year I can remember.  Moles sometimes appear in clusters and groups in different areas of the body, especially during the early teen years. It is rather rare that a mole will eventually become cancerous.

A skin doctor or dermatologist looks for “the ABCD's” to make a diagnosis of melanoma:

1.  A – Asymmetry – any two halves of the mole do not look the same

2.  B – Border – edges irregular, not perfectly round and smooth

3.  C – Color – not a solid color, but many different shades /

4.  D – Diameter – larger than ¼ inch across

Also, if you notice that at any time a mole is becoming active and changing more than your other moles that you have, it should be checked by your doctor.

If you have ANY ONE of the above findings, you should immediately see a doctor about the mole, because it could be a melanoma.

I was good with all of these, except maybe the diameter issue, so I decided to see a dermatologist.  After waiting almost a month for an appointment, the dermatologist moved and spoke like a man who was totally bored and did not want to be in the office.  I got the impression he felt like he was a factory worker who had long ago lost interest in what he was doing.

After a very brief examination and scraping of the tissue, I was told that my mole was a mole, and nothing more.  He said it "must be removed," so it could not at a later time become a melanoma.  I was given just two options for in-office removal: scalpel surgery ($$) or laser surgery ($$$$).  No other information or treatment was offered.  When I asked if there were other options, I received a curious and wrinkled look as though I had asked something really stupid, and he just shook his head “no.”

I told him I would think about it.  And I did think about it – for 2 seconds.

I remember reading that in many parts of the world, bloodroot paste has a high rate of success and is used to remove moles, melanomas and other skin lesions.  When I got home I Googled “bloodroot paste” and found a very interesting and informative site from South America that sells a small jar for $9.95 plus shipping.  Within two weeks I started to apply it, using the directions that were included.

In less than two weeks the mole fell off, and left the cleanest and nicest little crater of skin where the mole used to be located.  It is now in the process of healing, and filing up nicely.

On top of that, I still have an almost full jar of bloodroot paste left over.  Of the original $10 jar, I figure I have used less than 25¢ worth of the paste.   A pretty good deal.  I wonder if the insurance companies know about bloodroot paste?

Peyronie’s disease connection

The message of this blog post that I write today is not that you should treat your moles with bloodroot paste.  No; that is only what I did.  You should do what you and your doctor decide to do if you have a mole or you think you have a melanoma.

The message today is that this is another great example of how a medical doctor sees and thinks in a certain way, and leads a patient in that one direction only.  The tunnel vision of the doctor allows him or her (and you) to think in one direction only. I guess you would not expect the Ford car salesman to sell you a Chevy, anymore than you would expect a Chevy car salesman to promote a Ford.

So, when you see the urologist about Peyronie’s disease, he will give you the usual patter:  “Yep, you have Peyronie’s disease.  No one knows much about it; there is no known cause and no cure.  Surgery is the only sure cure for it.  Yep, if it gets so bad you cannot have sex any more like a lot of men with this problem, I’ll just cut on you and that will take care of it.  Let’s wait a year to see if your Peyronie’s disease clears up on its own, or it gets so bad that you need surgery.  In the meantime, try not to worry.  Oh, you might become impotent; if that happens, don’t worry, I can give you a few drugs that usually work. If you want to try some vitamin E, you can do that, but it really doesn’t help.  Any, remember not to worry, OK? See you next year. And don’t worry.”  End of discussion, and out the door he goes. And you sit there deep in worry.

I did not get information about my mole from this doctor, and I sure did not get options other than HIS two choices of surgery.  I am glad that I knew about these options before I walked in because the conversation was more about the two choices of scalpel or laser, like it was my only choice between coffee or tea.

The medical doctor lives in a very nice world in which he or she thinks there is nothing outside of medicine and surgery.  The drug industry, the hospital industry and the insurance industry all work together to make sure all patients know that there is absolutely no one that knows anything about your body, your wellness, your sickness and disease, and your eventual death, more than your friendly MD.

Everyone says it is so important to get a second opinion, because, you know, two heads are better than one.  But, the drug industry, the hospital industry and the insurance industry, all doctors, nurses and others who work in the health care industry know that it is not acceptable – and dangerous – to say or do anything that contradicts the primary care doctor. You could get sued. There is that mysterious power of “How dare you! That is MY patient!” that controls and limits access to different ideas.

When a person goes for a second opinion, it is actually very difficult to get a true second opinion.  Asking for a true second opinion turns out to be an exercise in which the second doctor is usually given a chance to say that the first doctor is correct.  This is the famous buddy system.   Did you ever notice that for the second opinion, the second doctor wants to read your chart so that he or she can see what the first doctor did and said about you?  This is done so that the second doctor knows the direction to go with your problem.  The second doctor wants to read the first doctor's chart notes so he knows what to say – so he does not go against the thinking of the first doctor. All of this happens so that the patient is not made to lose confidence or faith in the medical doctor.  Is this not true?  Does society agree with this arrangement?  Sure.  Is this a good arrangement for different ideas and information to be given to the patient who would like options?  No.

So much for exchanging information or learning anything new, or challenging the established way while looking for a better, safer, less drastic form of health care.

And thus you know about a different way that I decided to treat my mole, and a different way that I decided to conduct my Peyronie’s disease treatment. If I did not think in a different direction I would still have Peyronie’s disease.

Peyronie’s Disease Treatment Via Direct Drug Injection

Drug injection trauma can lead to Peyronie’s disease

Peyronie’s disease treatment using drug injection into the delicate tunica albuginea of the penis is a medical therapy that is fast loosing favor.  One of the reasons is the lack of good results, the other is that injections often cause or aggravate PD.

This blog post about Peyronie’s disease treatment using direct drug injections (Verapamil, cortisone, etc.) should hit home for a large number of you.  Many men have undergone painful drug injections into the penis because their medical doctor thought it was worth the effort, and only found themselves worse for their effort.

First I will simply copy an article, “Extracorporeal shock-wave therapy in the treatment of Peyronie’s disease.”  This research discussion is essentially about Extracorporeal Shock Wave Therapy, ESWT (or ESWL as they call it here).  This article comes from www.pubmed.gov under the reference number PMID: 15114750 [PubMed – indexed for MEDLINE].

What is important to note in our particular discussion is the area I have highlighted for emphasis.  You will note from an earlier post about ESWT in Peyronie’s Disease Treatment Forum blog, this form of therapy has been fairly well abandoned by a large percent of doctors who used it for many years since these injections seem to cause more problems than it helps. The reason this information about ESWT (or ESWL) is included in this article about penile injections is that these Russian physicians make a very interesting comment while discussing ESWT that underscores the damage created by injections (of any kind) into the tunica albuginea.

[Article in Russian]

Neĭmark AI, Astakhov IuI, Sidor MV.

The authors analyse the results of treatment of 28 patients with Peyronie’s disease using extracorporeal shock-wave lithotripsy (ESWL) performed on Dornier U15 lithotriptor. A total of 2-6 sessions were made, maximal number–12. The efficacy was controlled by clinical indices and ultrasonic investigation (Doppler mapping of the blood flow). ESWL proved to be efficient in the treatment of Peyronie’s disease (PD), primarily, in patients with early disease before appearance of severe fibroplastic alterations. Less plaque vascularization by energetic Doppler mapping due to ESWL is an important diagnostic criterion of PD treatment efficacy. Conservative treatment is not indicated in marked deformities and plaque calcification, erectile dysfunction. Moreover, any injection into the tunica albuginea, especially complicated by hematomas (deep tissue bruising) may be a damaging factor which triggers fibrous inflammation. Such patients should be treated surgically. If the patient is interested in immediate results or is not interested in continuation of sexual life, the treatment is ineffective. Thus, ESWL is an effective, safe method of PD treatment but requires further study and accumulation of clinical experience.

It seems that the problems penile injections can cause is not that necessarily about the drug that is injected into the tunica, but the drug injection with a needle itself that is used to deliver the drug. An injection to deliver any drug, or sterile water, can cause injury to this delicate membrane.  This sets off an inflammatory response that can result in significant Peyronie’s disease plaque or scar tissue formation for men who as so predisposed.   Doing this once can be risky.  Doing this up to a dozen times over a few months, as is often the recommended course of therapy, just multiples the opportunity for injury to mount on top of injury.

This Russian research team offers the opinion that the effects of such injection into the penile shaft causes such significant Peyronie’s plaque development, that surgery is the best treatment option for the damage that it can cause.   Obviously, I do not agree with that, since surgery can also cause more scar development. Their conclusion is that they find men who receive these injections often eventually are rewarded with a disturbed and discontinued sexual life.

This idea is brought to your attention to demonstrate there are many in the medical community who agree with the same position that I have taken for many years now.  These doctors and I contend it is inherently risky, in fact, dangerous, to stick needles repeatedly into the penis for Peyronie’s disease treatment. Their  logic concludes that any treatment that can start or aggravate the very problem it is attempting to treat, is not much of a treatment.

It is unfortunate that the medical community turns a blind eye to the direct observation of poor results, serious irritation of the tunica, and the solid logic that reputes injections as a form of Peyronie’s disease treatment.  Those who continue to inject their Peyronie’s disease patients, and bring these men farther down the road toward greater plaque development, must be desperate to look useful or just ignorant of how Peyronie’s disease often develops.  It is so common for medical doctors to think only in terms of medicine and surgery, notwithstanding the tragedy that can often result from their limited thinking.

The PDI concept of using non-invasive methods to increase the healing response of the body is a safer and more trustworthy Peyronie’s disease treatment than some of the aggressive medial schemes being promoted today.

Peyronie’s Treatment Philosophy

Many elements in successful Peyronie's treatment plan

“What is the most important product or vitamin I should use to treat my Peyronies disease?”  I get that question all the time.

The correct answer is that there is no ONE important therapy; they are ALL important, especially when used together. Each alone has limited ability to make a difference with the fibrous Peyronie’s plaque.   But when used together as we advocate at PDI, their combined effort is capable of generating a healing response. None will work alone to get results that are equal to a wide-based synergistic approach to therapy.

There is no way to predict which vitamin or mineral or enzyme therapy will do the most for you.  Actually, there is no one product that can destroy the scar by itself or build you up sufficiently so you can do the job yourself.  I think they are all necessary.  The more you can do for yourself, the better the results will be against Peyronie’s disease.

Please read and re-read sections of the PDI website that describes the treatment philosophy and principles of synergy, found at Peyronie's treatment philosophy .  If you are having any doubts or indecision about what you are doing, you owe it to yourself to go over some of these points. You should educate yourself well about this terrible problem and come to fully understand why you are following this course of Alternative Medicine care.

There is a lot of good information for you on the PDI website.   If you haven’t spent a few minutes there lately, now might be a good time to just go over what started you thinking in this direction in the first place.   After you understand more about the philosophy that guides this process of eliminating the Peyronies plaque, it will be easier to follow your program well.