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Welcome to J Francois Eid, MD - Directly answering member questions in the "Medical Professionals" section below the Treatment boards.
https://www.peyroniesforum.net/index.php/topic,17819.0.html

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Author Topic: Thread for Guys in Xiaflex Trial - Currently or Previously  (Read 246726 times)

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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #50 on: February 01, 2011, 09:44:51 PM »

Oh that's good.   Let us know how that goes if you get a chance to post.   It seems like that was a long wait from when you finished up the study...did they say why this wait was so long?  (I'm just trying to figure out when I'll get the real drug, assuming I'm in the placebo group).

And you had side effects too right? Swelling and stuff I think I remember from your old post?  I guess the placebo can be irritating too.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #51 on: February 02, 2011, 12:22:20 AM »

Yeah BigK - I hope at this point that I am getting the placebo too.  If these are the results from the real drug, then I am really screwed.  I think it'll still be FDA approved and it'll still be better than verapamil... but it'll just be interesting to see what insurance does.  3-4k a shot is not an easy sell...and that's just the drug fee.  The docs and facilities will charge on top of that.  If you need 4 shots... is your insurance really gonna pay 15k?  It will be a battle Royale... but I guess most of these are won by the patients in the end.  MS and CF have very expensive drugs out there...and HIV does as well - and those are for life.  I hope insurance doesn't try to screw people on this.

I don't know where I read this, and I could be totally wrong, but I was under the impression that a "course of injections" would cost approximately $4k.  I think that's how they priced it for treating Dupuytren's contraction.  $15k would be really steep price to pay for something that will likely only provide a partial amelioration of the condition.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #52 on: February 02, 2011, 12:27:34 AM »

I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition. 

While currently discussing curvature change on this forum,  I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group. 

Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.   

One major difference between the phase II & III trials is that phase III is administering 4 injection cycles vs. 3 cycles in the phase II trial.  Maybe a 33% increase in the number of injections will translate into more favorable results?
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #53 on: February 02, 2011, 02:49:04 PM »


I don't know where I read this, and I could be totally wrong, but I was under the impression that a "course of injections" would cost approximately $4k.  I think that's how they priced it for treating Dupuytren's contraction.  $15k would be really steep price to pay for something that will likely only provide a partial amelioration of the condition.

Unfortunately it's 3-4k per injection (before the doctor's fee) for dupuytren's.  It may be less than Peyronie's and may even have another name altogether when they brand it. I think it might be an intrinsically costly substance to produce...perhaps... or perhaps they are trying to recover a very large R&D investment & taking advantage of a situation where there are no other non-invasive cures.

From the Dupuytren's Board:

Be sure to check the procedure with your doctor and the coverage from your insurance company. The three doctors I spoke with in California all follow a protocol where one injection is done and if a second is needed it will not be done for at least 4 weeks and each injection requires a vial of the Xiaflex. The insurance company may pay for the first vial but not the second or the third.

If you need three injections your out of pocket may be $900 + $3900 + $3900 = $8700. Auxilum discounts the first vial of Xiaflex and sells it for $3400 but each additional vial or prescription is priced at $3900.

I can have a NA procedure done every 4 years for the rest of my life and the cost will be less than one round of Xiaflex treatments which may or may not last as long as the NA and statistically the Xiaflex has a greater chance of serious complications in terms of ligament and tendon damage - at least that is what my doctor who was involved with the Stanford drug trials told me.


(Found at http://www.dupuytren-online.info/Forum_English/board/dupuytren/questions-about-ddand-xilaflex-injections-0_966.html)  Sounds like insurance is only stepping in a little bit for this poster... 8700 out of pocket for a partial cure is really steep... in my opinion anyway.   Incision and grafting surgery w/ Levine is billed at something like 40k for his fee, facility and anesthesia (with risk of impotence and sensation loss) but it is reimbursed for less than half of that after insurance coverage.  The out of pocket wouldn't be anywhere near 8700 for surgery though (depending on your plan I guess - but that would be a rough plan to be on if it were).  Maybe they're looking at surgery costs when they priced this.  If you have 4 cycles - as the study is doing, then that's $15,600 + doc fees (8 + 500 I'd guess).  So, 19,600 would be the bill for 4 cycles (8 vials) + doctor's time.  I think surgery is still more...but reimbursed probably around 15k.   Some of the guys on here have posted what they had to pay vs. what insurance paid...if you look around you'll find the figures - but I can't remember what threads they were in.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #54 on: February 10, 2011, 01:09:51 AM »

Good luck! 

Yeah, it's not the most comfortable thing in the world...i forgot but i think there are a total of 8 induced erections in the study (4 for the xiaflex and then 4 more later to measure any changes).  fun stuff
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #55 on: February 11, 2011, 01:49:28 AM »

BSSS,

If you meet the study criteria and don't have any excluding factors, I wouldn't worry much about being accepted. They still need men for the trial. 

Like you, my plaque is in the top area also (under the tunica) and there isn't much to feel.  However, I had a pretty large angle to begin with.  Like the other two guys reporting here, I had a 10 degree reduction after Cycle 1.  Hopefully, you will have great results also.  We should all be reporting Cycle 2 results in the next 7-8 days.

In your other post you mentioned about being nervous and possibly being embarrassed.  The situation is very clinical so I haven't felt embarrassed and don't think you will either once you're in that situation. 

Good luck, keep asking questions, and we're all looking forward to your reports. 

Humorous


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ohno

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #56 on: February 11, 2011, 09:14:35 AM »

I'm wondering if anyone who has had any success in the xiaflex trials have noticed a softening of the plaque? Thanks
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #57 on: February 11, 2011, 05:20:27 PM »

BSSS,

If you meet the study criteria and don't have any excluding factors, I wouldn't worry much about being accepted. They still need men for the trial. 

Like you, my plaque is in the top area also (under the tunica) and there isn't much to feel.  However, I had a pretty large angle to begin with.  Like the other two guys reporting here, I had a 10 degree reduction after Cycle 1.  Hopefully, you will have great results also.  We should all be reporting Cycle 2 results in the next 7-8 days.

In your other post you mentioned about being nervous and possibly being embarrassed.  The situation is very clinical so I haven't felt embarrassed and don't think you will either once you're in that situation. 

Good luck, keep asking questions, and we're all looking forward to your reports. 

Humorous




thanks Humorous3,

Will do on the questions.  I am concerned a little about a possible plaque being near the base as well.  Seems I remember you can be excluded if they can't inject there and I remember my original uro telling me he felt one there. Guess they'll check that out and will let me know.

I appreciate you guys posting updates here as well; it is encouraging to read them.

BSSS
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #58 on: February 12, 2011, 02:35:48 AM »

For you guys who are in the trial, I was wondering how they do the actual injections.  Do they run the needle horizontal through the plaque, or is it inserted perpendicular to the plaque?  And if they run it through horizontally, is the needle oriented parallel with the centerline of the penis, or is it oriented 90 degrees to the centerline?

My plaque is on the top (dorsal) side of the penis, which also happens to be where the neurovascular bundle is located.  So I'm wondering if they do anything special to avoid running the needle through a blood vessel or a nerve?
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #59 on: February 12, 2011, 04:59:45 AM »

I actually can't watch him do it... so I don't know exactly - but from what i felt, it's sort of horizontal & also on an angle.  My plaque is on top as well.  It probably varies for all patients due to the plaque location.  I'm not sure about the anatomy of the neurovascular bundle.  Verapamil injections have been done for many years so apparently they know how to deal with it.

In my case, I don't know if he does anything to avoid blood vessles or nerves...I assume he knows what to avoid... but either way, I had no bruising or swelling w/ the xiaflex (or placebo). With verapamil, it was very bruised and swollen.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #60 on: February 12, 2011, 11:00:44 AM »

I actually can't watch him do it... so I don't know exactly - but from what i felt, it's sort of horizontal & also on an angle.  My plaque is on top as well.  It probably varies for all patients due to the plaque location.  I'm not sure about the anatomy of the neurovascular bundle.  Verapamil injections have been done for many years so apparently they know how to deal with it.

In my case, I don't know if he does anything to avoid blood vessles or nerves...I assume he knows what to avoid... but either way, I had no bruising or swelling w/ the xiaflex (or placebo). With verapamil, it was very bruised and swollen.

When it was done, were you able to count the number of needle penetrations through the skin?
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #61 on: February 12, 2011, 03:00:35 PM »

For you guys who are in the trial, I was wondering how they do the actual injections.  Do they run the needle horizontal through the plaque, or is it inserted perpendicular to the plaque?  And if they run it through horizontally, is the needle oriented parallel with the centerline of the penis, or is it oriented 90 degrees to the centerline?

My plaque is on the top (dorsal) side of the penis, which also happens to be where the neurovascular bundle is located.  So I'm wondering if they do anything special to avoid running the needle through a blood vessel or a nerve?

bigk,

Like yours, my plaque is also on the top side (under the tunica) and more towards the base than the head.  I watch every time they stick me with a needle.  It's pretty much as Mike said - it's horizontal but at an angle and the needle tip is "headed for the plaque".  It's not straight down/90 degrees from center.  They don't go through the tunica but more off center.  If you look at the penis as a clock, from my view it is between 10 and 11 o'clock. I'm sure they inject there to avoid nerve damage. 

Another thing they do is try to spread the Xiaflex throughout the plaque instead of injecting it all in one place.  This is done by "walking" the needle back slightly after injecting some Xiaflex.  This also may break up some plaque if they inject, move it back somewhat and then push it forward a little, inject, and then move it back more, etc.  It's as if they have your plaque mapped on a grid.  This cycle they inject it into Row 1, positions 1, 2, 3 and 4.  Next cycle they inject it into Row 2, etc.  To answer your other question, they only make one needle penetration into the skin when injecting Xiaflex.  The other injection is to induce an erection so they can measure your curve and that's done before the Xiaflex injection. 

I think this answers your injection questions but if not, ask away. 

Humorous

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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #62 on: February 12, 2011, 03:46:19 PM »

bigk,

Like yours, my plaque is also on the top side (under the tunica) and more towards the base than the head.  I watch every time they stick me with a needle.  It's pretty much as Mike said - it's horizontal but at an angle and the needle tip is "headed for the plaque".  It's not straight down/90 degrees from center.  They don't go through the tunica but more off center.  If you look at the penis as a clock, from my view it is between 10 and 11 o'clock. I'm sure they inject there to avoid nerve damage. 

Another thing they do is try to spread the Xiaflex throughout the plaque instead of injecting it all in one place.  This is done by "walking" the needle back slightly after injecting some Xiaflex.  This also may break up some plaque if they inject, move it back somewhat and then push it forward a little, inject, and then move it back more, etc.  It's as if they have your plaque mapped on a grid.  This cycle they inject it into Row 1, positions 1, 2, 3 and 4.  Next cycle they inject it into Row 2, etc.  To answer your other question, they only make one needle penetration into the skin when injecting Xiaflex.  The other injection is to induce an erection so they can measure your curve and that's done before the Xiaflex injection. 


Humorous:  So it sounds like the "rows" are parallel with the length of the penis rather than perpendicular to it?  And if the injection on the first day is along a "row" in the 10-11 o'clock position, do they try to achieve some sort of symmetry by injecting a similar row in the 1-2 o'clock position a couple of days later?
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #63 on: February 13, 2011, 05:29:17 PM »

Humorous:  So it sounds like the "rows" are parallel with the length of the penis rather than perpendicular to it?  And if the injection on the first day is along a "row" in the 10-11 o'clock position, do they try to achieve some sort of symmetry by injecting a similar row in the 1-2 o'clock position a couple of days later?

bigk,

I used the 4x4 grid as an example of how I think the Dr. views the plaque and how he determines where to inject the Xiaflex to get the most effective distribution.  Yes, the rows run parallel with the length of the penis.  But for me, and as best as I can remember, the injection site is "always" in the 10-11 o'clock position.  Think of the injection site as the "axis" for the needle.  The first day (injection #1) he inserts the needle tip into the 10-11 o'clock position and goes to the furthermost part of the plaque of Row1, injects some medicine, and then "walks it back" as described earlier while injecting more medicine.  The next day (injection #2) and going into the 10-11 o'clock position again, he inserts the needle tip and goes to the furthermost part of the plaque of Row2, injects some medicine, and then "walks it back" until he is out of Xiaflex.  The next cycle he would probably work on Rows 3 and 4.  (Depending on the individual's plaque size, grids could be 2x3, 4x5, etc.)

I hope this clarifies the injection process from my perspective. 

Humorous

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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #64 on: February 13, 2011, 07:23:25 PM »

Humorous:  So does the injection strategy look like the attached sketch?
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #65 on: February 14, 2011, 02:24:16 AM »

bigk,

Yes, it certainly does.  I've added an injection point (red circle/dot at 10-11 o'clock), and a syringe (rather crudely) to your very good drawing.  The needle tip is at the furthermost point of Row 2.  What you have marked as injection sites are where they inject/release some Xiaflex as they walk the needle back. 

Your picture makes my words much more clear.  Thanks.

Humorous

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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #66 on: February 14, 2011, 08:54:43 AM »

Humorous:  Thanks for taking the time to "tweak" my sketch.  From what you have said, it looks like they avoid running the needle directly down the middle so-as to avoid hitting the neurovascular bundle.  I've done quite a lot of reading on collagenase in the past few days, and the good news is that collagenase will not break down blood vessels or nerves.  But even so, it makes sense that they would try to avoid it as much as possible in order to avoid mechanical trauma that could result from a needle stick.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #67 on: February 14, 2011, 04:24:40 PM »


When it was done, were you able to count the number of needle penetrations through the skin?

Just 1... the protocol only allows for 1 plaque to be treated even if you have more than 1...so they just puncture once.  The drawing reflects my experience as well, though I don't understand what the vertical lines you drew mean

They inject exactly where humorous showed...we must have very similar issues...and it feels like the chemical is released as the needle is withdrawn...and as far as the "walking back" thing - yeah that might happen in my case too but I don't watch it.  It burns...so it's hard to feel what is going on.

The thing that is a shame is that they will only target 1 plaque - so the optimal results are not achieved in my opinion.  Not sure why this is what they settled on with the FDA.  Urologists in practice will inject multiple plaques i am sure...and circumferential plaques need multiple injection points.

Btw, it won't break down blood vessles or nerves but i think it CAN break down the tunica if there's too much... that's why penile fracture is a risk in the informed consent.  And, possibly why they go so slow - with 0.57 mg * 8 over 24 weeks...rather than higher amounts and shorter time periods.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #68 on: February 14, 2011, 07:04:02 PM »

MikeSmith0:  The vertical lines that I drew were meant to denote the path that the needle would take inside the plaque

One thing I find curious (according to Humorous) is that they only inject xiaflex on one side of the centerline on day one, and they stay on that same side for the injection on day two.  I would have thought that they would want to inject equal amounts of xiaflex on both sides of the centerline so that the contracture could release more evenly.  If this is correct, then the other side will not receive any xiaflex until the next round of injections 6 weeks later.  As I'm writing this, I'm thinking that I am surely mistaken... it just doesn't make sense that they would purposely inject only one side but not the other.  Maybe you or Humorous can shed some light on this.
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Mathewfamily

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AA4500 drug testing has started for Peyronies
« Reply #69 on: February 15, 2011, 05:26:32 PM »

I just received my first injection yesterday.  I am excited to be part of this study and there is room for more men to be part of the study.  If you are from the Midwest and would like more information on joining the study, let me know and I will get you the contact information.  The medicine is extremely expensive and it has a very high success rate. 
The first shot was easy, pretty much no pain.  Now afterwards there is some pretty extreme swelling and bruising involved and the skin is very sensative like a rash.  No really pain unless you run or walk alot due to the sensativity.  My shot was around 1:30 PM and my shaft was approx. double in gerth from swelling but no real pain, just uncomfortable.  This morning the swelling has gone down but the redness is worse and the sensativity is worse.  I have not taken anything for pain since there is so little. 
I have to get my second injection tomorrow around the same time, not looking forward to that one.  I will update Thursday just in case someone is actually interested.
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George999

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Re: AA4500 drug testing has started for Peyronies
« Reply #70 on: February 15, 2011, 06:04:57 PM »

Please DO update frequently.  The more information we can get documented on this web site, the better for it we will all be.  Additionally, I and I am sure everyone else here wishes you the very best results from this treatment regimen.  Thanks so much for posting!  - George
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #71 on: February 15, 2011, 10:11:28 PM »

well, the needle goes into the plaque horizontally - all the way across the plaque...so if you enter on the left, the needle goes through the plaque all the way to the right and the chemical is deposited as the needle is withdrawn, so there is even coverage i think....either way you enter....but yes, actually, in my case, one time he went in on the left, and once he went in on the right...same plaque... 1 day apart.  some people have more dense / obvious plaques (my case) so it is easier to pass the needle straight through the whole plaque.  people with thinner plaques probably have to be injected a little differently.

he said the protocol allows for doctor's discretion with this to an extent...given the variability in plaque size, shape, and density.  Also,  some people may be sore or bruised still...and i had a red mark so why risk further skin abrasion & re-injecting the same area.  the only rule is that you can't really get multiple injections per visit into multiple plaques.  and there's only a tiny amount in this vial anyway.. .like 1cc or 2cc at most.  

You don't get injected in those vertical line patterns...it's sort of horizontal / diagonal.  at least not for a dorsal plaque.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #72 on: February 16, 2011, 12:21:06 AM »

well, the needle goes into the plaque horizontally - all the way across the plaque...so if you enter on the left, the needle goes through the plaque all the way to the right and the chemical is deposited as the needle is withdrawn, so there is even coverage i think....either way you enter....but yes, actually, in my case, one time he went in on the left, and once he went in on the right...same plaque... 1 day apart.  some people have more dense / obvious plaques (my case) so it is easier to pass the needle straight through the whole plaque.  people with thinner plaques probably have to be injected a little differently.

he said the protocol allows for doctor's discretion with this to an extent...given the variability in plaque size, shape, and density.  Also,  some people may be sore or bruised still...and i had a red mark so why risk further skin abrasion & re-injecting the same area.  the only rule is that you can't really get multiple injections per visit into multiple plaques.  and there's only a tiny amount in this vial anyway.. .like 1cc or 2cc at most.  

You don't get injected in those vertical line patterns...it's sort of horizontal / diagonal.  at least not for a dorsal plaque.

You must be correct that the protocol allows for considerable discretion.  I'm pretty sure that Humorous indicated that the path of the needle was parallel with the length of the penis, but in your case, the needle was inserted all the way across the plaque (left to right, or right to left) without any concern for hitting the neurovascular bundle.  Is the attached sketch an accurate depiction of the injections that you received?
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Humorous3

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Re: AA4500 drug testing has started for Peyronies
« Reply #73 on: February 16, 2011, 10:30:07 AM »

Mathewfamily1,

Glad to hear you're in the Phase 3 Xiaflex trial and that you're reporting your results here.  There is a specific forum topic for us in the trial so I'm asking you to consider posting there.  It would be to all our benefit.  This is the topic to look for:

Thread for Guys in Xiaflex Trial - Currently or Previously

I have had six injections so far (three cycles) and I've had severe swelling and my penis was dark red to purple.  However, each cycle this happened only after the second shot.  I'm surprised that it happened to you on the first shot.  Different people react differently.  I'll be watching for your next post after your second injection.  Thanks again for posting. 

Humorous


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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #74 on: February 16, 2011, 07:44:41 PM »

I'm an engineer... I like to understand how things work.  Sorry if I've caused you any anxiety.
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samo

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #75 on: February 16, 2011, 09:36:22 PM »

I'm an engineer... I like to understand how things work.  Sorry if I've caused you any anxiety.

A wife asks her husband, a software engineer...
"Could you please go shopping for me and buy one carton of milk, and if they have eggs, get 6!" A short time later the husband comes back with 6 cartons of milk. The wife asks him, "Why the hell did you buy 6 cartons of milk?" He replied, "They had eggs."
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newguy

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Re: AA4500 drug testing has started for Peyronies
« Reply #76 on: February 17, 2011, 10:19:30 AM »

Yes, here's the link: http://www.peyroniesforum.net/index.php/topic,1458.0.html
The more information we get from those being injected the better. Please do keep us in the loop :).
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Mathewfamily

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Re: AA4500 drug testing has started for Peyronies
« Reply #77 on: February 17, 2011, 03:16:47 PM »

I will start posting in the specific forum area.  New to this so I didn't know there was such a page.  All future results will be there.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #78 on: February 17, 2011, 04:29:23 PM »

You must be correct that the protocol allows for considerable discretion.  I'm pretty sure that Humorous indicated that the path of the needle was parallel with the length of the penis, but in your case, the needle was inserted all the way across the plaque (left to right, or right to left) without any concern for hitting the neurovascular bundle.  Is the attached sketch an accurate depiction of the injections that you received?

i dont know... i dont watch...it was on more of an angle than that i think.  the NV bundle is above the plaque.. he knows when he hits the plaque bc it is thick & firm.  the very first touch of where the needle goes in lets him know it is the plaque.

i kinda agree with bsss though - now im gonna be nervous he's gonna hit the nv bundle.  well, if my VIs and 4 X shots already did not hit it, i assume they know what they are doing in this regard.
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Mathewfamily

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #79 on: February 17, 2011, 04:56:54 PM »

Well guys, I am officially a member of your club.  Pretty harsh entry fee, the shots!
This past Monday about 1 PM I had my first shot.  My plaque is towards the tip, centered and the PA entered the needle from the side straight in.  The first shot was pretty painless.  They wrapped it up so loose that it didn't stay on very long and was just a lump of gauze in my pants. The 1.5 hour drive home was uneventful, then I got home and showed my wife. By this time it was swollen the size of half a chicken egg on the right side only and just starting to get red, this was about 5:30 PM.  By 9:30 PM the shaft doubled in size from normal pretty much all the way around and it was very red with splotches of purple.  The odd thing was the head was normal in color and size?!?  Tuesday the swelling had gone down about half way but the colors were more even between the red and purple.  By Weds. morning, the day of the second shot, the selling was almost all gone but the deep purple was more so than the red.  My second shot happened at almost 2 PM.  This shot hurt bad, burned like a hot knife that lasted about 3 to 5 mins.  This time the doctor thought they should wrap the gauze a little tighter.  The ride home was uneventful however when I got out of the car and walk four steps my knees hit the ground.  It felt like someone was cutting it off right where the plaque is, it was the gauze wrap.  I barely got in the house and down the stairs to get scissors to cut the wrap off.  The swelling had no where to go so the base was big and swollen and the skin just under the head was swelling fast.  Once I got the wrap cut off the swelling went crazy, especially the skin just under the head towards the underside.  It looked like the frogs that blow up the underside of the jaw.  The swelling was so bad I really was afraid the skin would rupture but it did not, Thank God.  Lots of frozen corn and peas with Advil and Benedril.  I woke up this morning to less swelling but still pretty severe.  The bruising has now turned to an eggplant purple.  The skin is SO sensitive that just walking is very uncomfortable.  I really didn't think that it would be this bad but in the end, if it works, it will have been worth it.  I am only 36 and I have a lot of lovin' to give to my wife.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #80 on: February 17, 2011, 06:44:21 PM »

Well guys, I am officially a member of your club.  Pretty harsh entry fee, the shots!
This past Monday about 1 PM I had my first shot.  My plaque is towards the tip, centered and the PA entered the needle from the side straight in.  The first shot was pretty painless.  They wrapped it up so loose that it didn't stay on very long and was just a lump of gauze in my pants. The 1.5 hour drive home was uneventful, then I got home and showed my wife. By this time it was swollen the size of half a chicken egg on the right side only and just starting to get red, this was about 5:30 PM.  By 9:30 PM the shaft doubled in size from normal pretty much all the way around and it was very red with splotches of purple.  The odd thing was the head was normal in color and size?!?  Tuesday the swelling had gone down about half way but the colors were more even between the red and purple.  By Weds. morning, the day of the second shot, the selling was almost all gone but the deep purple was more so than the red.  My second shot happened at almost 2 PM.  This shot hurt bad, burned like a hot knife that lasted about 3 to 5 mins.  This time the doctor thought they should wrap the gauze a little tighter.  The ride home was uneventful however when I got out of the car and walk four steps my knees hit the ground.  It felt like someone was cutting it off right where the plaque is, it was the gauze wrap.  I barely got in the house and down the stairs to get scissors to cut the wrap off.  The swelling had no where to go so the base was big and swollen and the skin just under the head was swelling fast.  Once I got the wrap cut off the swelling went crazy, especially the skin just under the head towards the underside.  It looked like the frogs that blow up the underside of the jaw.  The swelling was so bad I really was afraid the skin would rupture but it did not, Thank God.  Lots of frozen corn and peas with Advil and Benedril.  I woke up this morning to less swelling but still pretty severe.  The bruising has now turned to an eggplant purple.  The skin is SO sensitive that just walking is very uncomfortable.  I really didn't think that it would be this bad but in the end, if it works, it will have been worth it.  I am only 36 and I have a lot of lovin' to give to my wife.

Thanks for the detailed account of your experience.  What is the starting angle that you're trying to correct?  How many times did the doc. insert the needle?  From your description, it sounds like you got a shot (or "shots"?) on the right side on day one, and then another shot(s) on the left side two days later?
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LWillisjr

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #81 on: February 17, 2011, 07:47:32 PM »

I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then they waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.
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Mathewfamily

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #82 on: February 17, 2011, 08:53:58 PM »

I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then the waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.


I had the VI injections too and these shots are less painful and less invasive.  These shots are short and the needle is extremely small.  However the drug burns when it gets injected the second shot.

BigK

I am starting at 55 degrees of curvature.  The doc gave me both shots on the right side in the same location only inserting the needle in once.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #83 on: February 18, 2011, 01:25:43 AM »

I'm curios about the Xiaflex injections. I had Verapamil injections and they always first gave me a numbing injection first. This was done with a much smaller gauge needle with two injections, one on either side of the base of the penis. Then they waited about 10-15 minutes before actually doing the VI. I'm curios if they also do the numbing injection prior to the Xiaflex injection.

lwillisjr,

They offer to give you the numbing injection if you want it.  My choice was to get one injection instead of two.  The needle they use to inject the Xiaflex is very small gauge so it isn't very painful. 

Humorous
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #84 on: February 18, 2011, 02:00:17 AM »

I've finished the Cycle 3 injections.  But since they measure you before the Xiaflex is injected, first let me say there was a 10 degree improvement from the Cycle 2 shots.  Add that to the 10 degree improvement from Cycle 1 and that makes me pretty happy.  The Dr was pleased also. 

Back to the injections.  The first one was no problem, as usual.  Maybe a little redness at needle entry point but no swelling.  The second one (given the next day) is the "bad" one.  I've swollen substantially and turned dark red to purple the first two cycles.  But for some reason, this time was different.  While there was some swelling and redness, it was nothing like before.  That was a pleasant surprise.  Now I'll model (when I remember) and wait for the measurement at the next cycle in six weeks. 

When you combine the 20 degree improvement and the reaction to the injection every cycle, I think it's safe for me to say (the Dr can't, of course) that I'm getting Xiaflex and not the placebo

Humorous
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #85 on: February 18, 2011, 01:06:02 PM »

I've finished the Cycle 3 injections.  But since they measure you before the Xiaflex is injected, first let me say there was a 10 degree improvement from the Cycle 2 shots.  Add that to the 10 degree improvement from Cycle 1 and that makes me pretty happy.  The Dr was pleased also. 

Back to the injections.  The first one was no problem, as usual.  Maybe a little redness at needle entry point but no swelling.  The second one (given the next day) is the "bad" one.  I've swollen substantially and turned dark red to purple the first two cycles.  But for some reason, this time was different.  While there was some swelling and redness, it was nothing like before.  That was a pleasant surprise.  Now I'll model (when I remember) and wait for the measurement at the next cycle in six weeks. 

When you combine the 20 degree improvement and the reaction to the injection every cycle, I think it's safe for me to say (the Dr can't, of course) that I'm getting Xiaflex and not the placebo

Humorous


nice news to hear Humorous! Hope the good results continue!
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newguy

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #86 on: February 19, 2011, 08:30:48 AM »

That's fantastic news Humorous3. I'm heartened to hear of your improvement and am very happy for you :). Let's hope there are many more positive reports over the coming weeks and months.
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Worried Guy

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #87 on: February 19, 2011, 12:28:32 PM »

Great news :)
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ohjb1

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #88 on: February 19, 2011, 04:34:39 PM »

I was in the prior phase of the drug trial and received the placebo - no change at all.

I see a number of posts on this thread where men who have noticed a change for the better automatically assume that they received Xiaflex and not the placebo. If you read Auxillium's own results from Phase II of the clinical trail you will note that a significant of percentage of men who received the placebo also improved - so much so that they met the goal of 25% improvement.  This is a mysterious finding. 

Of course, its all postive to improve, but erroneous to assume it was due to the Xiaflex.  Hopefully, as results of the current phase of the trial come in we will all know more.

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bummedout

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #89 on: February 20, 2011, 09:50:35 AM »

I'm curious to know, of the people who have "measured" improvement from their injections, have you noticed "real life" improvement?  Also, I am also curious to know if the injection is causing any kind of softening, shrinking, or dissolving of scar tissue.
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ohno

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #90 on: February 20, 2011, 03:23:49 PM »

Me too. Any softening of the plaque (scar)?  Also I remember Dr. Mulhall  when telling me about the verapamil treatments that he felt pretty sure that it was more the swisscheesing effect than the verapamil which caused any improvement.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #91 on: February 20, 2011, 04:50:10 PM »

Me too. Any softening of the plaque (scar)?  Also I remember Dr. Mulhall  when telling me about the verapamil treatments that he felt pretty sure that it was more the swisscheesing effect than the verapamil which caused any improvement.

I've been doing quite a bit of reading on how collagenase works, and I suspect that the plaque doesn't get softer, but instead, it just gets smaller.  When the medicine is injected, it affects an area of about 1.5 to 2 mm near the injection point.  So the total diameter of the affected area would be 3.5 to 4 mm.  Since they give two injections in each cycle along a line perpendicular to the long axis of the penis, and assuming that the second injection is offset by 1 or 2 mm from the first one, it's plausible that the zone in which plaque is eradicated would be approximately 6 to 7 mm wide.  

It turns out that a 60 mm long plaque will result in a 90 degree bend.  So the length of plaque resulting in a 10 degree bend would be 6.7 mm.  Based on the zone over which the medicine should have some action, and based on the amount of plaque that must be eradicated to achieve a 10 degree improvement, it totally makes sense to me that Humorous3 has had a 10 degree improvement with each injection cycle.  I therefore suspect that he is receiving the real medicine instead of a placebo.

If Auxillium keeps the same pricing structure as it is for Dupuytren's disease, then it appears that it will probably cost about $7,500 for every 10 degrees of improvement that is required.  And so if you start out with a 90 degree bend, the total cost could end up being 9 times $7,500, which equals $67,500.  Let's just hope that they come up with a new pricing structure that's more reasonable than that.  I've heard of the $6 million dollar man, but it seems kind of crazy to have $68,000 penis!
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #92 on: February 20, 2011, 05:33:32 PM »

bigk -  that's a very speculative post? humourous isn't the only one in the study (results will vary) and one would presume an approved treatment won't be priced 3-4 times higher than basic surgery ... I'd be interested to hear views on how this drug affects the plaque from qualified urologists involved in the study if any of the trial participants would care to ask and post - I feel that would be more useful to the people following this thread.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #93 on: February 21, 2011, 12:31:12 AM »

bigk's post was interesting...i am a quantitative person too  so i can appreciate that analysis - but i don't know that you can actually quantify this as precisely as he did & say it is that uniform.  however, it's an interesting calculation...i'm not sure where all the numbers come from in terms of X mm = x degrees of curve, etc.  There are a lot of variables affecting this curve (plaques can be in the septum, laterally oriented, and under the corpora as well - some are thicker than others, penis size varies, etc...).  Also re: his analysis -  If you think of another injectable like botox, you can somewhat quantify how far the paralyzing will go per each number of units in injected.  It may be apples and oranges to compare these two though.

I think xiaflex softens the plaques, dissolves the plaques, and also lets them detatch from the tunica...as well as potentially triggers a more appropriate healing response once some of the plaque is broken down.  That's the general idea of what has been explained to me by the docs but nobody knows "exactly" what it is doing under the skin...but that is the general intent of the drug.

The pricing will be rough.  4k x 8 injections is just really high for most insurers.  Chemotherapy, MS, HIV, and CF drugs are like this in terms of price too, however...some of these are much more life & death than Peyronies Disease (though Peyronies Disease's affect on quality of life is severe in many cases) so perhaps the battle wont be as bad.  The DC crowd had a few months of battling but auxilium has staff working with the major insurers to explain the drug fortunately.  The alternative to X for the DC crowd is a procedure that's fairly reliable and relatively lower risk.  The alternative to X for Peyronies Disease is a very invasive surgery with nearly guaranteed loss of size, potential impotence, and potential sensation loss...so I'm sure the AUX team has their powerpoint slides ready & waiting for blue cross, aetna, etc...

The other problem is that  it won't be on the market for a long time, I don't think...based on the Xiaflex calendar with DC.  It took a while even after phase 3...which I think is done at the end of 2011.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #94 on: February 21, 2011, 01:11:52 AM »

I found the information regarding 90 degrees of bend per 60 mm plaque at this link:  http://peyronies.org/pages/mechanics.htm.

And I found the information regarding a 2mm radius from the injection site at this link:  http://www.patentstorm.us/patents/4338300/description.html

I took some time to read the Auxilium phase IIb results, and it looks like the average angle of improvement was a little less than 6 degrees per injection cycle.  So a 10 degree improvement per injection cycle is definitely on the high side, but certainly not out of the realm of possibilities. 

When collagenase is used for duputren's, they inject nearly all of the medicine into a very localized area in the cord, and even after doing that, they still have to work pretty hard to "snap" the cord.  So it kind of makes sense that using it for Peyronie's will require multiple injections due to the large volume of plaque that has to be dissolved and/or softened.
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burnoutz

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #95 on: February 22, 2011, 01:56:07 AM »

hi i am a newbie in this forum, i would like to know whether xiaflex is suitable for someone who has peyronies for 10 years +? My penis is not bent but it is pointing downwards and not flexible. Masturebation is ok but sex is difficult. The only treatment that i tried was vitamin E and L-arginine it did not give much effects at all.The base of my penis is hard, i guess its the fibrosis plaque. And may i know when will xiaflex made available for the public? 

thank u..
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #96 on: February 22, 2011, 02:32:33 AM »

hi i am a newbie in this forum, i would like to know whether xiaflex is suitable for someone who has peyronies for 10 years +? My penis is not bent but it is pointing downwards and not flexible. Masturebation is ok but sex is difficult. The only treatment that i tried was vitamin E and L-arginine it did not give much effects at all.The base of my penis is hard, i guess its the fibrosis plaque. And may i know when will xiaflex made available for the public? 

thank u..

I'm not sure if you are asking if you'd be eligible for the study or if you can just get the drug?

From what I've read you have to have a certain amount of curvature in your penis and that can't be downward or that would exclude you from the study.

As for a release to the public, I'm not sure.  I do know the current phase of the trial lasts until March 2012. I don't know how long the open label part lasts or how long it takes for them to gain FDA approval.  If you're waiting for it to be released it could be 2 to 3 years I would think.

Sorry I don't have more or better news.

BSSS
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #97 on: February 24, 2011, 05:05:26 AM »

well i have had no results... no side effects...and a smaller penis every time i look at it.
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #98 on: February 24, 2011, 09:09:58 AM »

MikeSmith0:  I'm really sorry to hear that you're not getting the real stuff.  Just today I'm considering going to see a shrink to ask about getting some meds... this is the most God awful thing I've ever had to go through, and I have definitely been through some big health scares in the past.

If you would like to complain about the stupidity of having a placebo group for these trials, you can do so by going to this link:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplaintsrelatingtoClinicaltrials/default.htm

And if you are interested in getting another opinion for surgery, you might want to check out Dr. Gelman in California.  I called his office with some questions, and much to my surprise, Dr. Gelman actually called me back himself.  If I ever have surgery, I think he will be my first choice.  Here is a link to his website:

www.centerforreconstructiveurology.org
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GS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #99 on: February 24, 2011, 10:40:18 AM »

Mike,

Trust me, I feel your pain.  I tried to get into a trial in Kansas, but I was turned down because of taking pentox.  They said I would have to be off the drug for 90 days and they were closing recruitment in 30 days, so they were going to get someone else.  I was relieved and disappointed at the same time.  I guess at least I don't have to worry about being in the placebo group.

At the same time all this was happening, one of my coworkers was having triple bi pass heart surgery and one of my best customers had a heart attack while shoveling snow.  He was in the hospital for 15 days; he is home recovering now.

So, I sat back and thought to myself...well, at least I didn't have a heart attack.  And, hey, I'm going to live to fight Peyronies another day.  Somehow, those thoughts made me feel better and I went back to thinking about my improvement so far with my VED and oral supplements.

Although Peyronies is a terrible and terribly frustrating disease, things could always be worse.  Try your best to hang in there.

GS
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