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Quote from: MikeSmith0 on January 30, 2011, 11:08:38 PMYeah 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.
Quote from: ohjb1 on January 31, 2011, 05:46:01 PMI 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.
Quote from: bigk on February 02, 2011, 12:22:20 AMI 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.
Quote from: Humorous3 on February 11, 2011, 01:49:28 AMBSSS, 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
Quote from: MikeSmith0 on February 12, 2011, 04:59:45 AMI 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.
Quote from: bigk on February 12, 2011, 02:35:48 AMFor 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?
Quote from: Humorous3 on February 12, 2011, 03:00:35 PMbigk, 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.
Quote from: bigk on February 12, 2011, 03:46:19 PMQuote from: Humorous3 on February 12, 2011, 03:00:35 PMHumorous: 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
Quote from: Humorous3 on February 12, 2011, 03:00:35 PMHumorous: 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?
Quote from: bigk on February 12, 2011, 11:00:44 AMWhen it was done, were you able to count the number of needle penetrations through the skin?
Quote from: MikeSmith0 on February 15, 2011, 10:11:28 PMwell, 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.
Quote from: bigk on February 16, 2011, 07:44:41 PMI'm an engineer... I like to understand how things work. Sorry if I've caused you any anxiety.
Quote from: bigk on February 16, 2011, 12:21:06 AMYou 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?
Quote from: Mathewfamily1 on February 17, 2011, 04:56:54 PMWell 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.
Quote from: lwillisjr on February 17, 2011, 07:47:32 PMI'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.
Quote from: lwillisjr on February 17, 2011, 07:47:32 PMI'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.
Quote from: Humorous3 on February 18, 2011, 02:00:17 AMI'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
Quote from: ohno on February 20, 2011, 03:23:49 PMMe 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.
Quote from: burnoutz2010 on February 22, 2011, 01:56:07 AMhi 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..