Thread for Guys in Xiaflex Trial - Currently or Previously

[peterjackson]

Additionally, there is a new topic on the boards. Rather than spell out all the "higher" boards to direct you there, just use this link to get there.

[jackwert]

I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now

[agent0]

omg i hope your not trolling jackwert, and i seriously hope this works with my numbness. PLEASE GOD PLEASE!

[skunkworks]

I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now

Starting to sound like it would carry as much risk as surgery (albeit with more reward). I cannot remember that coming up in the dupuytren's trial though.

[jackwert]

No im not trolling I have peyronies disease too im 20 years old. I've had it since i was 18 and i hate it just as much as you do

[LWillisjr]

I would be cautious of your doctor's statment about "Xiaflex definitely works". This could lead to the perception that Xiaflex is the cure all drug. Did it help some men in the trials.... yes. Did it help everyone... no. I had a recent discussion with my doctor and Xiaflex results. I posted them here:

https://www.peyroniesforum.net/index.php/topic,903.msg40614.html#msg40614

[jackwert]

underdog peyronies patient of the year call me rocky

[addboy]

I saw my urologist about a month ago and I asked him about if he thinks xiaflex could help. He began telling me how he actually was one of the doctors participating in clinical trials and he said it definitley works and completely dissolves the scar tissue. But then he mentioned how if the xiaflex is injected in anywhere else but the scar tissue it will mess up healthy tissue in the penis. Anyway i guess its just a waiting game now

My Uro said the same thing. He needs to locate the plaque before he can administer Xiaflex. He said it should be available within the nexts couple months though.

[jackwert]

Did xiaflex help anyone gain back length or girth?

[ThisWontWork]

Did xiaflex help anyone gain back length or girth?

Not me

[jackwert]

well what did it do for you?

[ThisWontWork]

well what did it do for you?

Nothing ! it didn´t gain neider girth or length or curvature. I think it´s as good as placebo! Xiaflex is bogus! Auxilium wants in next step rob your wife on some $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ for here cellulites. 98% of all women have cellulites that they hate. They will pay Auxilium some billion dollars to get rid of these nasty wrinkles. It´s all about money nothing else.

[james1947]

Sorry it has not worked for you ThisWontWork. I believe that the doctor capability have a lot to do with the improvement on the placebo group also.
I just read the article on the link posted by Doksoul, maybe we will now in a very few month if it helps or not.

Regarding:

rob your wife on some $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$ for here cellulites

It will not happening with my wife, I don't like skin and bones woman configuration. Like also my stake with some fat

James

[MikeSmith0]

This WILL work.

30% is not great...but they have to just figure out the best way to inject it.  And, the doctor who injects it must do a good job.  The FDA trial was one-size-fits all...same dose for everyone, same injection for everyone....yet penises vary and plaques vary.  And, collagenase may not be good for huge plaques - and it may not be great for super thin plaques (spilling out into the area under the skin).   And why did they just make 1 injection - not 2 or 3?  With verapamil, the needle passed through the plaque a dozen times.  I don't think they even know the best way ... it hasn't been studied.  It's not easy to study.

Injection techniques will be at physician discretion in some ways, once this drug is approved...though dose unfortunately will probably be constant.  Also, in the real world, we can use traction in between - which will help more.

The trial had to be restricted and prove the concept of collagenase in Peyronies Disease vs a placebo.  They did that. Now it's time to refine the technique and see the academic publications come out with empirical studies about injection technique trials.  I think the 30% improvement is only the beginning.   The problem is that Peyronies Disease research labs have very little money (with a dead NIH too) and MDs are too busy, unless paid by AUXL.  IF they had any cash, I'd throw it at improving the xiaflex injection technique...because all of their future revenue is going to depend on that.  

[TooYoungForThis]

Does anyone know how I can get into one of these trials? I live in SF bay area CA area and I have severe hourglassing in the base of my penis.


I am desperate, please help.

[MattFoley]

The trials are over. My understanding is that we are now waiting for the FDA to approve it for Peyronie's. Then, let the games begin.

By the way, I'm in the Bay Area as well.

[Chopsuey]

Hi all,
I haven't posted on here in quite awhile due to frustration. I waited so long to get into a trial, only to be given the placebo. Then I had to wait almost another year before getting the real drug. I just started the first cycle with the real drug. I can definitely tell the difference in pain, swelling and bruising. There was even a "crack" during my first modeling with the urologist. My doc told me these are all good signs. He said the drug work well on about 70% of the guys in the study. Now I just have to be good about about doing my own modeling at home. I'll let you know in a bout a month or so if I show any significant improvements. I am 40 degrees bent and lost about an inch or so in length.

[funnyfarm]

chop is the pain better or worse with the xiaflex ? thanks.  

[MattFoley]

Chopsuey, what do you mean by "crack" and "modeling"?  

[Ive]

Chopsuey, what do you mean by "crack" and "modeling"?

He means when after they have injected the Xiaflex the specialist manipulates/stretches the penis. Sometimes the plaque cracks audibly. Remodelling is the term used for stretching or relocating the plaque so that it doesn't cause such a significant bend.

[funnyfarm]

This may explain why many of the placebo patients saw improvement, but raises question about the effectiveness of xiaflex, since it was not alot better than the placebo.

[MattFoley]

OK, so the placebo is saline and then they manipulate the penis. And they got results like the ones in the study? OK, forget the Xiaflex, just shoot me up with saline and manipulate my penis. How much is that gonna cost?

[JohnG]

My urologist got me into the practice's research physician and I'm now in line to get the xiaflex.  My first injection is March 31 with 2nd injection and modeling the next two days.  

I really want to hear from other people who have started and what I can expect.  My Urologist is Dr. Bailen at FirstUrology in Louisville KY

[james1947]

JohnG

You may find the answers at:
Thread for Guys in Xiaflex Trial - Currently or Previously - Peyronies Society Forums

James  

[LWillisjr]

JohnG,
My assumption is that Xiaflex injections are identical  or at least VERY similar to Verapamil injections. You can search a bit on VI's (Verapamil Injections on this site and find exp erenice from several members (including myself) how have experienced these. I would suggest taking an ice pack with you to place between your legs on the way home and expect a lot of bruising for several days.

[pointedly]

I used to use an icepack after my Verapimil injections and my PA who was administering told me not to.  If I remember correctly, he said that the cold causes any excess fluid to leave the area - including the drug itself.  I would check with your doc on that...

[Carbonlib]

I asked my dr, Coy Carson at unc if the injections were about the same, and if i remember correctly, he said the needle was much smaller.....

did any of you guys acutally LOOK while getting your VERAPAMIL?


i sure didn't...

[PMRT]

I had verapamil shots a year ago.  No luck.  I just finished my first week of Xia-Flex shots.  I can tell you they are DEFINITELY not the same.  Xia-Flex is far more virulent or potent.  The swelling and bruising is far more extensive.  Not much direct pain afterwards unless touched or handled.   Ice packs, 20 min's on and 20-30 min's off for a couple hours after the wrap is removed and laying on the couch with your feet up (gravity is the enemy here) is recommended and I found helped a lot after the second shot of the week.  Don't be surprised if your package turns deep purple or even black.  I developed a blood blister at then injection site as well that broke on it's own.  Pretty standard, I'm told.  I am a survivor of terminal cancer of 12 years ago.  That was very painful but nothing compares to the pain I experienced during "modeling" yesterday.   Do yourself a favor and ask for a pain block before modeling.  It is an option.  I will definitely ask for it next time.   Modeling is when the doctor takes the scare tissue and tries to break it up by hand.  Oh, man!  Three- 30 second manipulations.  Excruciating does not adequately describe it.

For those of you who don't believe it, yes the entire treatment protocol runs about $25-30K.  You get shots 2x/week separated by 4-6 weeks (for recuperation) for a total of 4 sets.  I read the study. Average improvement is about 35 degrees or so.  While not typical my doctor had one patient that went from 90 degrees to 10 degrees. Xia-Flex is for dorsal (plaque on top) problems.  A picture in the study of what they call a 35 degree bend looks almost straight to me so I am hopeful.  I am probably at 65 degrees to start. Improvement doesn't come until nearer the end of the treatment.   I don't check this site at all so if you have a question you can email me at paulmrt57@gmail.com.  I will try to answer.    

[james1947]

PMRT

Even you don't check this site at all, thank you for the update.
Maybe you will find time to give us an update regarding the results when finished the Xiaflex sessions?
It will help other Peyronies sufferers to chose this way.

James

[IhatePD]

PMRT I wish you they best. Please keep us posted on your progress.

[gnosis]

Dear Carbonlib

I have an appointment with Dr. Carson tomorrow.  How do you like him?

I have a nice story about recovering from Peyronie's mostly from alternative approaches.   I shared it on the list a few years back.   .   a combination of Bill Zarick, email deleted by moderator, a bodyworker, siddha yoga healer--60%, chris spivey (VED and iontophoresis--verapamil)---Birmingham urological --20%, and Paul St. John, body worker in St. Petersburg, FL--10%.

I still have the curve and wondering whether to try to improve that.  Erectile Function not only came back from the dead but really improved even compared to pre-peyronie's.   Also lots of good exploration of sexual-emotional satisfaction has happened.  Is there a peyronie's club in the triangle?   I'm new to the area.   Gnosis  

[chapel hill]

I see Dr Carson as well. I have seen him for some time. I enjoy him as a person. I have great respect for him as a healer. I am sure you will do well with him also.

[james1947]

gnosis & chapel hill

This topic is for Xiaflex trials.
Why you are hijacking the topic?

James

[BrooksBro]

It has been about three hours since my first Xiaflex injection.  Compared to the 8 ml injected for each of 12 Verapamil injections, this 0.25 ml was nothing.  And, unlike with the Verapamil, it was not necessary to precede the Xiaflex with lidocaine for pain reduction.  It was only slightly uncomfortable when he pushed the needle into the thickest part of the plaque.

I was not expecting the extensive preliminary examination.  There was the usual physical exam by the doctor, followed by a trimix injection to produce an erection (it helped to look at soft porn books), and then an ultrasound exam (by an attractive female tech!).  I needed another trimix injection before they could get a good angular measurement (50 degrees upward) and mark the point of maximum curvature.  Then there was another injection to make the erection go down.  Finally, the Xiaflex was injected.  Today, I felt a bit like a human pin cushion!

I left wearing a snug wrap of self-clinging elastic bandage (co ban).  That is becoming a little uncomfortable.  I am unsure how long I will have to wear it.  Perhaps the take home material has some information.

My next injection, without the extensive work-up, is in two days (Wednesday), with modeling two days after that (Friday).

I will try to scan the take home materials and post them here later this week.


My insurance (BCBS PPO) covered the procedure at 80%.  My co-pay for today was $85.

[RoyHobbs]

Thanks for the update, Brooksbro. How long did it take for your insurance to be sorted out? I was told 4-5 weeks and I'm nearing two months now waiting for the okay.

[BrooksBro]

It started in mid-February.  See this post for more information.

$28,000.00 for Xiaflex injections... - Peyronies Society Forums

[BrooksBro]

The Xiaflex provided patient instruction sheet is attached.

[RoyHobbs]

Thanks, Brooksbro.

[NeoV]

Interesting that they have manual penis stretching as part of the treatment in the handbook.

It's helped me tremendously, though it's no cure, but what is?

[james1947]

NeoV

BrooksBro posted the patient instruction sheet, two posts bellow.
Maybe is written there something regarding manual stretching.

James

[BrooksBro]

SECOND XIAFLEX INJECTION on April 9 2014

I had my second injection late yesterday afternoon.  The urologist quickly examined me and said the bruising and swelling were typical.  He then said "it is working."  I suppose he could feel the plaque softening from the first injection.  I was extra tender at the site of the plaque.

The second injection was a little more painful than was the first, but it was tolerable.  They use a 25 gauge needle, and the injection is only 0.25 ml, so it does not take long or require pain medicine.  They again applied gauze and wrapped it with co-ban, telling me it was OK to remove it after 2 hours.  When I removed it about three hours later, it was much more painful than I remember it being after the first injection.  It was painful enough that I took some Vicodin that I had previously been prescribed.  That let me get through the night well enough.  I took more this morning and applied an ice pack for a while.  It is still very swollen and uncomfortable, but the pain level is low enough that I expect to make it through a day of work.  I will apply ice more tonight.

I go back late Friday for my first modeling.  The docs said they have another handout on modeling that they will give me to follow for the next six weeks.  When I get that, I will post it here.

I am beginning to understand why they administer this in "divided doses."  If it is as potent as it appears, giving all of it at one time would be more than most men could tolerate.

[james1947]

BrooksBro

Thanks for the detailed update.
Let us know how the modeling was Friday.
Wish you a very successful treatment.

James

[Knight]

Ouch! Hoping this is all worth it for you! The modeling sounds awful if I'm understanding the process correctly.

Sending hope and God's speed in you complete recovery!

Good luck and thanks for sharing!

[KAC]

Wishing you the best.  KAC

[BrooksBro]

The first modeling procedure was free of discomfort.  It was nothing.  I was reassured again (is that redundant?) that I got "the real thing" and not a placebo, based on the swelling, discoloration, and pain that I have been feeling.  Not everyone has pain (I do!), but the swelling and discoloration are characteristic of the medicine working.

If you want to know a whole lot more about the injection procedure, go to the website that Xiaflex has developed to help train physicians - Xiaflex REMS   -  Xiaflex - collagenase clostridium histolyticum

As for the cost, Friday I was told that the medication is distributed as a "kit" which contains two vials of the medicine, and two vials of the diluent.  The full price for one kit (two injections) is $3,000 (US).  Each person is different, and they may require 1-4 injection series (two injections per series).  The doctor's fee for performing the injection is highly variable, and I don't have any data for my own experience yet.  I did have an $85 co-pay for each of three visits last week.  Depending on the physician, they may or may not, perform an induced erection and ultrasound before each series.  This helps them to identify the plaque location, and the point of maximum bend.  If they do this before each injection series (6 weeks apart), then there will likely be higher costs for these procedures and the medicines used.

I received a letter from BCBS (TX) saying that pre-approval was not necessary, although this  was done by the medication distributor (one of several regional distributors in the U.S.) before shipping the medicine to my physician.  It further said, injections for Peyronies are a covered procedure.

[james1947]

BrooksBro

Again, thank you for the update.
Let us know if you see some improvements.

James

[Timdvm]

I was diagnosed with peyronies 2 1/2 years ago.   I had verapamil injections a year ago with no Improvement.  I began xiaflex injections last Thursday.   Had the second injection today.  I was very surprised that the swelling and bruising was so severe.   Currently I have a 90 degree bend -
 

[james1947]

Timdvm

Thanks for the update and keep us updated.
Let us know also where you got the injections.
I am not surprised regarding the bruising. Read down the topic, you will have many posts mentioning bruising.

James

[Timdvm]

The swelling is much improved today, but still very sore.   Entire length of the shaft is black and blue.    I got the injections from a urologist in Edmonds Washington - he is part of the drug release program.  

Update.  Swelling is going away, the bruising resolving.   I started the remodeling three times a day.    Does anyone have any advice on how much traction tension should be applied?  Or what has worked for them?    

[james1947]

Timdvm

Good to read that you are better.
Regarding traction, do not increase tension over comfortable feeling!!!

James