Developmental drugs & treatments - Still in trial or not approved for Peyronies

[Hawk]

I might add that bruising is of course bleeding internally in the tissue.  Blood in tissue can possibly cause scaring.  Do they apply direct pressure after the injections or instruct you to apply pressure?  If so and you are not applying pressure for 10 minutes it may be worth asking about.

[jackisback]

Ted,

Are you for sure that insurance would not cover off label Xiaflex? Wow, what a disappointment. I can't afford $10K for such a thing, and not sure that I'd want to ask my parents to spot me either.

[ohjb1]

I believe that I read somewhere that the treatment would cost between $ 4000-5000. Still expensive, but not 10K. Guys, I think we are getting ahead of ourselves, before getting our hopes up let's see what the study shows.

[G.]

Just to support what Hawk said:  when I got the first injection of the first round, they told me to apply pressure for a few minutes and I did so.  And I had no bruising.  When I got the second injection a couple of days later, I think they were in a hurry to get the next patient in, and they kind of hurried me to get dressed and get out of the room.  And that is the one I got the terrible bruising after.

So I definitely learned my lesson, and am going to make sure I have proper time to apply pressure, next time.

[Ted Williams]

Insurance companies typically don't cover the cost of off-label use of products.  This is especially the case when a treatment for say, your hand is applied to your penis.  The other thing that will likely come from this is that pain will be a requirement for certain insurance companies to cover the cost of the treatment.  These are moves done by bean counting insurance companies to control costs.  So, what we will probably see is a pre-authorization form for the use of Xiaflex.  It will specifically indicate treatment of Duprentyn's contracture.  

When the product is finally authorized by the FDA for the use in the penis, you will see all of the Peyronie's sufferers reporting "agonizing pain" as a result of the condition in order to get their insurance companies to cover.  

Ted

[George999]

Ted,  Just a couple of comments regarding insurance issues.

1)  With off label treatments a lot depends on the cost.  This could be a real problem for Xiaflex.  As the cost of a given treatment escalates, insurers get progressively more fussy about off label issues.

2)  Another factor is who the doctor is that is prescribing the off label treatment.  If the doctor is a member of the health plan in question, your chances for coverage are higher.  If the doctor is a prestigious doctor AND a medical expert for your health plan, that boosts the potential for reimbursement even further.

Such has been my experience in the past.

 - George

[seaside2]

Or if he is willing to stretch the issue slightly to avoid the question. not saying I know of one that would do this, but  

[Fredca]

Anyone know if stimm cell research is being done to recreate tissue? Isnt Peyronies then one of the things it could solve?  

[jackisback]

"InterMune (ITMN) is expected to release Phase 3 results next month for pirfenidone in the treatment of idiopathic pulmonary fibrosis."

Source: multiple google news hits.

I say it's about time, and I hope that this may be able to replace Pentox in our routines.

Tim, given your background, do you think it is likely that this drug will be available to Peyronie's sufferers in America soon (i.e. this year)?

[George999]

Once its FDA approved, it can be prescribed off label.  The question then becomes who is going to prescribe it?  Its a new drug with long term side effects not totally clear at this point.  Will it be enough better than pentoxifylline to justify the risk?  Doctors are going to think long and hard about issues like this.  Additionally, pentoxifylline is dirt cheap, pirfenidone will likely cost a kings ransom.  I can GUARANTEE you insurance companies won't pay.  If you can, you MIGHT be able to get your hands on it.  Whether or not it will be worth the extra cost remains a question.  From my perspective, pentoxifylline combined with vitamin D does the job and I would be willing to wait a long time for something like pirfenidone.  But to each his own.  - George

[j]

Perfinidone isn't new.  Intermune bought the rights to it years ago, intending to sit on it because they had their own, competing product.  This inconvenienced a patient who was being kept alive by it; he sued and won a judgement against Intermune that forced them to begin trials of Perfinidone, and to continue to make it available to some number of patients.  So the trials now being concluded were underaken only because of a judge's order.  Whether Intermune actually intends to make the drug available remains to be seen.

http://www.thefreelibrary.com/Pulmonary+Fibrosis+Patient+Sues+InterMune,+Charging+Unlawful,+Unfair...-a096863347

[Gregory]

We are now at the end of January.  Shouldn't those in the Xiaflex trial have received the second series of injections by now?  Can any report their results?

[ohjb1]

Did receive my second set of injections. Urologist said he detects a slight decrease in plaque size. I don't notice any difference in curvature, which is all that matters.

[Ticker]

I received my second series of injections on Jan,13 &14.I am still sore.Was really black and blue this time.Way more than last time.I had very little or no swelling.I will be going to get measured Feb 12th but have not noticed any difference.sorry,Ticker

[roadblock]

First of all, I want to say thanks to all of the trial participants who are posting here periodically. Even more so, I am thankful for those of you participating despite feeling that you are getting the saline injections! If Xiaflex ever hits the market for Peyronies Disease, it's because of people like you.

With that being said, we have yet to have a single trial participant say anything about any improvement whatsoever. It is disheartening to read these post knowing 2/3 of you should be getting Xiaflex injections! In the Dupuytrens trials, the effects were pretty dramatic and immediate...right? I guess statistically it is still possible that everyone that is posting here participating in the trial could be receiving the placebo injections. But there is little that I wouldn't give to see someone on here post a positive experience from the injections thus far!!

[ohjb1]

Correction to Roadblock - It is not 2/3 who are getting the drug, it is 3/4

[Old Man]

Note to all:

Just had DC surgery thus past week. My surgeon was not aware of Xiaflex. He did the usual incision type repair.

He said that Xiaflex sounded like a good way to go and he would explore it and let me know what he found out. Maybe we can find something about it through his efforts.

Old Man

[pjh]

Hi everyone
 This is my first post. I have been a "reader", like so many other members who post nothing, but read quietly looking for some kind of answer to their problem on this forum. I've read so much on what works/doesn't work, might work a little, etc. One day I saw the URL for the IIb Xiaflex trial posted on this site. I took a chance, found a location listed close by (85 miles each way) and called and asked to be admitted. I went for an interview, physical, detailed measurements, history etc., and was accepted! I had my first series of two injections, and subsequently felt that I was in the "placebo" group. There was no immediate reaction other than swelling and bruising. Nor was there anything positive thereafter. I had never been able to find a "plaque" anywhere, but the urologist I was assigned to, after a lot of squeezing/bending, found two! Enough said for my professional urologic abilities. I was again measured for amount of deviation, to see if I qualified for "round two", which consisted of injections 3 and 4, separated by one day. The Dr. injected into the original site for the third shot (where injections both #'s 1 and 2 were done) and the 4th injection went into the "other" plaque site (near the base, not the "bend"), as the Dr. felt that they were all related to the overall "distortion". Swelling and bruising followed, but when the discomfort subsided, I found a definite improvement in the "bend" in the erect state. The firmer the erection, the "straighter". I also found that my penis hung down more "straight" when flaccid, especially obvious when in the shower and well soaked in warm/hot water. I also found that the "hinge" to the right was MUCH less pronounced. Almost even resistance to deviation left and right, while initially at 3/4 from the base, it almost "fell" to the right, and resisted normally to the left. All of this to me indicates that Xiaflex has potential. I'll know more after (if?) I qualify for "round three", which is injections # 5 and 6. That qualification is based on measurements still to be taken to see how much deviation still exists. As I understand it, if a patient comes within 15 degrees of "straight", then they don't qualify to continue. More to follow if/when I "advance".  Most participants in the trial are probably reluctant to post too much so as not to jeopardize their participation in the trial, myself included. I had to answer the post seeking more info from participants though, as others have already (courageously) posted. We all need some kind of affirmation in our struggle with this disease if something seems to show promise. As a layman, my thoughts are that when dosage and frequency are "dialed in", Xiaflex will be an answer, if not THE answer.  

[Believer]

pjh,

On behalf of all other forum members, I thank you for posting your results.

I think we desperately need to know the potential of Xiaflex. Xiaflex is the only thing that holds me back from seriously considering surgery. I am willing to wait and suffer if I know that it will be a viable solution. Thus, hearing encouraging comments makes the wait less painful.

Thanks, and please post more!

[Attica!]

pjh,
 
  Thank you for sharing your results and experience. I assume you had to sign a confidentiality agreement before starting the trial, thus your statement about not posting "so as not to jeopardize their participation in the trial, myself included."
  However, if you can do so safely, could you tell us how long you have had Peyronie's, your age, your degree of bend and curve before the injections, loss of length and girth, and anything you have done prior to the trial injections i.e. VED, traction, prescription drugs, vitamins, etc.
  Thank you again.

[rbwoodward]

As a trial participant and one who has had peripheral exposure to the process of bringing experimental drugs through clinical trials to market, let me say that we should all sit back and let the Xiaflex trial play out.  First of all, this is a grand experiment.  We do not really know what to expect in terms of improvement after all rounds of treatment have been concluded, much less one round.  According to my doc, multiple injections may be required to observe any effect.  Second, remember that 25% of us are receiving placebo, therefore there will surely be some non-improvers.  Third, the trial participants do not represent a homogeneous group nor should it be.  By that I mean, there are many different types of Peyronies Disease patients participating here.  As an example, there are probably long-term and short-term Peyronies Disease participants in the trial (though all must be stable).  Possibly there will an advantage for the short-termers based on having less plaque calcification (or not, who knows?).  Maybe those with larger plaques will see a different level of improvement compared to those with smaller plaques.  Age differences could be significant.  This is what experimentation is all about.  Let's be patient, as difficult as it certainly is for all of us.

My results so far after first round of injections---a slight improvement.  Now awaiting the start of my second round.  I am optimistic.

[G.]

pjh,

Thanks also for posting.  Glad to hear someone is seeing something positive out of this.

fwiw, I go in for second round of injections this coming week.  No change at all after first round.  As I posted previously, I'm not concluding yet, which group I may be in.
 
I asked the doctor last week if anyone in his trial was seeing improvement - he really didn't want to get into any detail at all, but with the stated proviso that he has no idea who is getting the drug and who is getting the placebo, he said yes, some people had improved so far - and he hastened to add, that some people improve spontaneously, anyway.

I think the key to posting impressions here, with all due discretion, is that this is a randomized, double-blind study.  None of the participants nor the doctors, know who is getting the drug and who is getting the placebo.  Therefore anyone posting their impressions here is doing so with the understanding that they really have no idea what group they are in, and won't until the study ends.  It's also well-established that a fair percentage of Peyronie's patients see some improvement, without treatment, so a report here of improvement is still not necessarily evidence that this product is working - yet.

I'm not a lawyer, but I think the above provides a valid rationale for posting our impressions here.  It's just conjecture, until the results are released.  On the other hand, if a number of participants post here to the effect that they're seeing progress, well, that would be a real encouragement to everyone.

Attica - I haven't gone back and re-read the agreement lately, but I did read it twice before signing it originally, and I don't recall seeing anything about confidentiality.  Again, just my opinion, but I think if we discreetly post our impressions in this members-only forum, I don't think we are violating any terms of agreement.  Maybe Tim could comment more broadly on standards for participant confidentiality in these kinds of studies.

G.

[j]

From what I read, the Dupuytren's trials were quite successful  BUT the treatment wasn't just Xiaflex.  They injected a small amount of Xiaflex to weaken the cord at its midpoint, then applied a LOT of force - enough to finish the job by snapping the cord with an audible pop  -  and sometimes that hurt quite a it. Probably most of the fibrotic tissue unchanged, but snapping the cord in the middle was enough to release the finger.

Dupuytren's forms "cords" that in many cases are firmly attached at their endpoints but not in the middle. So if you sever the cord at its center, you restore range of motion. Peyronie's isn't like that, the affected tissue is more integrated with the surrounding, good tissue.  There is no 'cord', just an area that's become stiff with collagen fibers.

I think the Xiaflex treatment for Peyronie's will be more effective if combined with traction and stretching - possibly immediately after the injection. I also think multiple injections over time may be needed, and more attention will have to be paid to the targeting and amounts. With luck, these issues will be worked out over time.

As always - just my own non-professional opinions.

[Old Man]

j:

Had DC surgery on Friday, Jaanuary 23, 2009. Will see how mine works out. The doc did not know about Xiaflex or any other form of treatment.

Old Man

[pjh]

Hi all. Attica, in answer to your questions, no I don't remember a confidentiality agreement. I am just of the opinion that discussing personal results of a trial still in progress publicly could  possibly antagonize the trial sponsors. Could that lead to expulsion? I hope not. This site is semi-public in that it isn't limited to professionals with a "need to know" or password only available to such types. It may be something of a risk to post, I assume. I took it based on a need to share info about our common problem that was only available from participants. Others had shared somewhat, and this forum is made up of people who share willingly what experience they have garnered over time. It was just my turn to step up to the plate, having never done so. Other answers: I'm 62 years old, and have had this curse for about four years. My degree of bend was 60 at the start of the trial. Length and girth wise, when this problem first occurred, I was taking Proscar for BPH for several years, and thought that the lack of DHT was causing something to happen "hormone wise" to me. Besides lousy orgasms, I found I was getting "smaller", like some kind of reverse puberty! I often wonder if Proscar (which I no longer take) was some kind of "trigger" for all of this. I mentioned this to the "trial urologist, but he said no. He also was reluctant (meanng "would not go there") to answer my question as to if any of his other participants were having any success or not. Things I've tried with no success: Vitamin E, oral, all forms, (tocotrienals, etc). Vitamin E oil applied topically simultaneously with DMSO. MSM, Quercetin/Bromelain, copper tablets, serrapeptase and nattokinase. BTW, once I had a "brainstorm" to break open the enteric coated serrapeptase capsules and apply it topically with DMSO. The idea was to get the serrapeptase to the plaque to dissolve it. BAD IDEA! Ulcerations followed, that it took my urologist to cure. I never tried any vacuum therapy or traction type devices. I was always afraid of doing further damage with them. Also, fwiw, I am not in the "modeling group" in the Xiaflex trial. Any other trial participants who wish to share their experiences so far, I'd like to know if they parallel mine, though I realize that there are many variations among us as relates to our common scourge.    

[Tim468]

G covered the issues well. As no one knows what they are getting, then their impressions here cannot (and will not) influence the outcomes of the study.

I have never had a patient sign a confidentiality agreement to participate in a study, though I guess that is done sometimes.

If someone came here and lambasted the company for how they do their research, that would be another issue - but still worth hearing about IMHO. What is reported here is ethical doctors doing ethical work - I kind of like it!

Tim

[Ptolemy]

Old Man, what is DC surgery?

[Old Man]

Ptolemy:

DC stands for Dupuytrens Contractures which is related to the symptoms of Peyronies Disease. The leaders/tendons in one's hands form a hard cord restricting the extension of the individual fingers.  Surgery is performed to relieve the condition.

In my case, the ring and pinkie fingers on my left hand were drawn in so that I could only open my hand about 45 degrees, etc. After this heals, I should be able to open my hand all the way as before DC started.

DC, Peyronies Disease and Lederhose condition on feet are all related in one family of condition as per some doctors. I have all three. Peyronies Disease under control, Lederhose is increasing somewhat.

Regards, Old Man

[j]

Old Man, I likewise have all 3 and have had surgery for DC on both hands.   Currently DC is attacking my left thumb and right index finger, and I expect to be looking for some sort of treatment before too long. I hope it will be Xiaflex.  

[Believer]

I am not a trial participant, but for those who are interested, I have the Xiaflex trial agreement in PDF and can post it with this forum's administrator approval. It basically lays out all the details of this trial.

[Old Man]

j:

Mine was so bad I could not straighten out my ring and pinkie finger enough to hardly pick up a glass.
Anyway, tomorrow we get the first bandages off to see how it came out.

Old Man

[Hawk]

I am not a trial participant, but for those who are interested, I have the Xiaflex trial agreement in PDF and can post it with this forum's administrator approval. It basically lays out all the details of this trial.

I assume it is a public document.  If so, feel free to post it.

PS: Old Man,  I hope you have a great outcome on the DC surgery.

[Believer]

Unfortunately the file is too large to post (1.1mb). If anyone wants it, just e-mail me at peyroniesqa@yahoo.com.

[husbands support]

Gentlemen:

I was angry in my first post on this board.  I realize I am an outsider and I have come into your domain.  And my first contact with you is semi scolding the members here.  When I first reviewed the boards here I got a little exasperated with what I see as the lack of mobilizing your efforts.  I apologize to every member here for being disrespectful.  

My husband has to have hope. And I am trying to give him hope.  Three years of peyronie's has really hurt more than his penis.  His spirit has been stripped from his personality.  I am trying my best to be his advocate.  His new hope is he will be accepted into a trial that fights tgf-beta.    

Last week I went to the clinical trials link, searched for TGF-beta trials " http://clinicaltrials.gov/ct2/results?term=TGF-beta " to locate TGF-beta trials.
None of the trials were peyronie's related.  That is shocking.  Urologist are dragging their feet re peyronie's?  So I have taken it upon myself to contact urologist, to make them aware of the trials and the drugs involved in the trials.  

First I contacted uros affiliated with the universities and hospitals conducting the trials.  Like I said, shockingly these uros are not even aware of the TGF-B trials at their own facilities. Why, I ask myself, don't they stay on top of their (game) and try and make headway against peyronie's?  And that is where I come in.  I am politely, respectfully keeping them aware of the challenges they need to get involved in fighting peyronies.  I emphasize politely and respectfully otherwise they may view me as a reminder of how they are failing their practice and their patients.  I also contacted uros not in the university/hospital circle of the trials.    

I think I am making inroads by alerting doctors of the opportunity to get involved with these trials.  When writing and phoning doctors I sometimes played on their opportunity to make a name for themselves among their peers by being in the vanguard of peyronie's treatment.  If you gentlemen have additional ideas how to broach the topic with doctors lets share them now.  And, most importantly, let's not let these ideas die on this board.  Let's put them to work.  Let's share them in our correspondence with the doctors we contact.  
   
It always helps to be polite when speaking with doctor's and their assistants on the phone.  So far a lot of them seem to be very receptive to the idea of starting their own trials.  Will they follow up on that is the question.  Maybe it will take members of this community to follow up with the doctors to keep this issue in their sights.  

Using mail merge in Windows I use a form letter and insert individual doctors names into the letter. I mailed out letters to twenty urologists informing them of their chance to get involved in tgf-beta trials.  It is my hope that a few doctors have the clout to start their own tgf-b peyronies trials.  

So now my husband has more of a chance for serious treatment besides the anecdotal treatments currently available.  Can I ask your support gentlemen.  I ask you to help me and help the community by using your resources.  I think I have laid out a respectful templet for keeping urologists in the vanguard of the promising treatments that are coming available every day.

Let's hear from you gentlemen.  Who did you write this week?  What material did you include in your packet to a particular uro.  Maybe we can target a few specific uros to make more of an impact.  We can make a difference.

Thank you and I hope you accept my apology.

[Old Man]

HusbandsSppport:

Welcome to the forum. As you progress in your quest for help with Peyronies Disease, you will find out that Peyronies Disease and related men's health problems makes "strange befellows".

It seems that this subject has taken a back seat for centuries and breaking it out into the open medically will take time. Good luck to you on your efforts in helping your husband.

Regards, Old Man

[George999]

husband's support,  Fighting TGF-beta1 is definitely one of the current best ways to effectively deal with Peyronie's.  But you need to be aware that there are already urologists offering a TGF-beta1 drug.  That drug is Pentoxifylline aka Pentox or Trental.  It is a TNF-alpha/TGF-beta1 inhibitor that is effective, inexpensive, easy to take and has few side effects.  There is documentation on this site supporting its use in the treatment of Peyronie's.  I recommend that you familiarize yourself with it and take steps to get your husband on it.  It is also important to know that blocking TGF-beta1 will essentially stop the progression of the disease.  It DOES NOT instantly reverse the damage already done.  That can only occur by a natural process of healing that takes years.  You also need to be aware that the use of a TGF-beta1 blocker does not fix the problem.  It only patches the problem.  It is my strong suspicion that the problem is caused by chronic vitamin D deficiency.  There is a blood test that your husband's physician can perform to determine whether your husband is vitamin D deficient.  My suggestion is that you familiarize yourself with this problem at http://www.vitamindcouncil.org and then discuss it with your husband's primary care physician.  The Vitamin D Council is run by a team of top Vitamin D scientists and physician specialists.  Be sure to note that the recommended level of Vitamin D is 50-80ng/ml, NOT the 20ng/ml which most labs show as normal.  This is what is misleading many physicians to assume vitamin D levels are OK when they are not.  New evidence is demonstrating these old recommended levels of 20ng/ml to be severely deficient and to have dire health consequences.  I wish you the very best in dealing with this very frustrating disease.  - George

[Hawk]

Husbands Support,

Welcome to the forum.  I am glad you returned to post.  It was difficult to tell from your first post whether you were in fact a concerned spouse or a drive by bomb thrower with a fictitious persona.  It seems clear from this post that you are a committed, articulate spouse that has experienced some of the same frustrations of most people dealing with this condition.  I think I speak for the vast majority of members when I say that while your explanation and apology are appreciated and readily accepted, they are not necessary.  We understand your frustration and your point.

I am very impressed with your commitment to translate your concern into practical action.  While sharing ideas on the forum serves many objectives, your example of action is one we need more of.  We have made several significant attempts to initiate an advocacy and awareness campaign but I can give us no better than a D- and that is being generous.  I do think it is important that such action be well thought out and that it should be at least somewhat coordinated.

I will look at the link you provided on the TGF-Beta trial.  I am also interested in seeing a copy of the letter you sent.  You can send it to me via Personal Message (pm) if you like.  I am also interested in some idea of how effective you found the results to be.  Did you actually get any ear time with any urologist either in person or on the phone.  Did you get any ear time from their staff?  What was the response ratio and character of those responses etc?  I think this information is valuable in assessing what works and what does not along with what just needs tweaked.

One thing is certain, such effort is very unlikely to decrease interest in Peyronies Disease and regardless of the level of success it likely does represent success on some level.  Such an effort is much like sales.  After you hone a good approach it is basically a numbers game.  You have some ratio of success regardless of how high or low and you approach enough individuals to meet your goal.  The fact that several ignore you or respond negatively is nothing but a statistical reality that you navigate as you work toward your goal.   Simply put, every "NO" is positive because it gets you closer to the inevitable "Yes" you are looking for.

Thanks again for your return post.  I hope you will not be a stranger here.  Your views, your attitude, and especially your move to action rather than endless talk is a valuable contribution to the Peyronies Disease community.

Regards

Hawk

[Peggy]

where are all the xiaflex guys?  how's it going?  there are 120 of you..speak up please!  Thanks!

[joe]

I got into the Xiaflex study right at the deadline so I just had my first set of 2 injections a little over a week ago (one on Tuesday 1/20 and one on Wednesday 1/21).  The 1st went ok but after the 2nd my penis swelled up and was pink & purple.  The Dr told me to apply pressure for 5 minutes after each but I guess I wasn't in the right spot the 2nd time.  The bruising lasted almost a week but is now gone.  If I touch the plaque it feels sore now like a bruise - never did before.  

I haven't noticed any improvement yet, in fact it is slightly worse than before.  So either it doesn't work quickly, doesn't work for everyone, or I got the placebo.  I go back in a month for measurements and I'll update everyone on my progress.

Joe

[Believer]

thanks for posting joe

[jayhawk]

Joe,
you are a brave man! that does not sound like fun!

[ohjb1]

For some reason, my dr said applying pressure was not necessary. I have bruising, but no swelling.  Not as bad as when I had the Verapamil injections and pressure was applied.

Don't think we are necessarily brave, just desperate for some improvement.

Had my 2nd set of injections a few weeks ago and no improvement noted in the curvature.

 

[jayhawk]

are you using any stretching with or after the injections?

[Old Man]

Note to all:

Please be advised that based on my experience with verapamil and ED injections it is of utmost importance to apply pressure to the puncture site!!

Believe me, I know first hand about bruising, swelling and long time healing processes. Every doctor administering penile injections of any kind should advise patients receiving them to apply pressure after each shot

Old Man  

[ohjb1]

to Jzyhawk - I am in the modeling group. twenty four hours after the last injection there is stretching

[G.]

Peggy:  In addition to the posts of the past couple of days, there were a couple of other posts about this, about a week ago - see in particular pjh's post from Jan 24 - that one is particularly interesting since he reports there was no improvement after the first round of injections, but improvement after the second round.

jayhawk:  to clarify about the stretching (modeling) regimen (I'm in that group too):  you're instructed to do the stretching 3x a day, during the duration of the trial.  ohbj1's reference to stretching 24 hours after the second injection, refers to a scheduled follow-up visit where the doctor does the stretching on you - not sure why they schedule that - maybe to ensure that you are doing it correctly.

Joe:  Thanks for posting.  pjh's post indicates that sometimes it take more than one series of injections to see results, so hang in there.

Having just had my second series of injections, I'm starting to suspect a pattern in how people are reacting to the injection, and am starting to think that the 'hematoma due to not applying pressure' issue may be a red herring - based on my experience:

First round of injections:
1st injection:  applied pressure afterwards.  No swelling or bruising.  Just a slight tender lump.
2nd injection (48 hours later): didn't apply as much pressure afterwards.  Starting 1.5 hours after the injection, started feeling painful burning feeling on shaft.  Shaft swelled up, ended up black and blue.  Folks here, plus Dr. and study coordinator told me this was due to a hematoma and not necessarily evidence of reaction to the study drug, so I accepted that logic - until the second set of injections I just got this week.  By the way, no change at all in curvature, after first round.

Second round of injections:
1st injection:  applied firm pressure for 5 minutes afterwards.  Like with first round, no swelling or bruising at all.  Was very tender along entire shaft though.
2nd injection (24 hours later):  again, applied firm pressure for 5 minutes afterwards.  There was definitely no follow-up bleeding going on.  However, like with first round, 1.5 hours after injection, began to feel painful burning feeling on shaft, which again swelled up.  This time though, the whole swollen area was only pink - no sign of hematoma at all.  However it was severely swollen and very painful.  It was only when I woke up the next morning that it was black and blue - which I attribute to some capillaries breaking/leaking during erections I had overnight.

So this seems like a pattern:  with or without the bleeding, the first injection in each series produced little reaction, whereas the second injection produced severe pain and swelling, eventually turning black and blue.  At this point I'm starting to think that this is probably evidence of the study drug - I just can't see how I'd get this powerful a reaction, merely to injection of saline.  The phrase "chemical surgery" came to mind, when I was in the midst of the worst swelling and pain.

48 hours after the second injection, saw the Dr. again for follow-up modeling session.  I described the above to him.  He's a pro and emphasized that he is 'totally blinded', but did allow that he is developing a 'suspicion' as to who is getting the study drug and who is not - based on the degree of severity of the reaction to the injections.  I mentioned I'd heard that in some participants, improvement was not seen until after the second round, and he affirmed that he'd seen that.  I told him there was still no change in my curvature, and he told me to keep my hopes up.

I'd meant to wait until the swelling/bruising reduced somewhat more before posting, but was prompted to do so now by the other recent posts.  I'll report back later this coming week if there's any improvement once the bruising heals some more.

Good luck to everyone who is participating in the study.

G.

[bones54]

Okay...first post.  Xiaflex study participant.

Completed my first set of injections this past week.  Significant bruising after 1st set ..in spite of direct pressure for at least 40 minutes followed by a night of ice on dorsal plaque.  Not in remodeling set.  Additional swelling on pubic area and at area surrounding injection area...now 2 days after 2nd shot and just now noticing decreasing swelling.  Hard to believe this reaction of swelling and discomfort over plaque is normal saline...but who knows?  Everyone hopes for the med.

More to come.

[G.]

bones54,

Thanks for posting.  A quick question: When you had the reaction from the first set of injections, was the bruising and swelling seen immediately after the first injection, or did you not get that reaction until after the second injection? - am very curious to see whether there is any pattern to this.

Also, btw for what it's worth:  the first time I had the swelling and bruising and spoke to my Dr.'s study coordinator to report that, she advised me to avoid using ice for the first 24 hours, to maximize the effectiveness of the drug - she advised tylenol but nothing else.  You might want to confirm this with your Dr., but maybe something to keep in mind for next series.

G.

[ohjb1]

Each cycle consists of 2 injections which are spaced from 24-72 hours apart.  Timing is based on patient preference and his reaction to the treatment. If there is significant pain, bruising or swelling the dr will wait until these symptoms improve. In my situation, I have had the injections 24 hours apart.  The day after the first injection, there has not been any swelling, bruising and some minor pain.  After the second injection, there was considerable bruising and some discomfort. Both were gone in less than a week.  For those in the modeling group (I am in this group) 24 hours after the 2nd injection the dr performs the modeling (stretching) exercises.  In theory, this will help to distribute the drug and assist in breaking up the plaque.  Overall impression is that my urologist is very careful and the side effects of his treatment have been tolerable. But, then again there is no improvement after 2 cycles.  

 

[rbwoodward]

My experiences are in line with the last few postings.  Second round completed.  Not in modeling group.  Swelling after 1st injection, but tolerable discomfort.  But oh baby, it was a rough ride after the 2nd injection.  Increased bruising and swelling laid me up for the entire next day.  By two days post-2nd injection though, I was significantly improved.  Same pattern occurred during my 1st round, so G, you are probably correct about a pattern.  Interesting, my doc is not having me apply prolonged pressure after the injection.  We will discuss this on round 3!  I think I had a very slight improvement after round 1, and am optimistic about further improvements especially considering pjh's and G's posts.  There is just no way that I am in placebo group given these responses to the injections.

Has anybody heard whether or not xiaflex will be offered to the placebo group after completion of the study, assuming a positive outcome for this trial?
RBW