UK Xiaflex Trials

[newguy]

That's a great video WorriedGuy. It touches on the exact concern I mentioned to you in a message a couple of days back. Dr Lue says in the video that's it's a minor concern, so hopefully that will prove to be the case. It could mean that men will be somewhat limited in terms of how many courses of this treatment will be allowed.  

[smithgareth]

Thought this thread was about the UK Xiaflex trial, not an opportunity for Worriedguy and newguy to have a pop at Xiaflex!

I'm not being funny guys, we've read the risks, we've surfed the net and we don't need you guy's throwing concerns around it's not the time for if's but's and maybe's!

I'm giving Xiaflex a go, if it works brilliant, straight up and a happy wife. If it doesn't I've lost nothing cause it doesn't work now! If it does and it works for a good percentage of people on the trial it may, and I stress just may, make thousands and thousands of peoples lives better.

I don't care if my penis ends up a bit thinner, if it's straight enough to go in thats all that I care about.

[MikeSmith0]

He just said the tunica could be thinned out - and he means that it would happen acutely, by the process of injecting too much into a spot that doesn't have much scar - so the collagenase might dissolve some of the collagen in the tunica.  That (in a severe case) would result in penile fracture, as he stated.  It has not happened in any of the trials, though it is a warning we've all been told.  Similarly, a small number of people had tendon ruptures in their hands after xiaflex in clinical trials.

The actual penile girth itself would hopefully expand if xiaflex was able to dissolve and release the tension of the scar... well, that's my hope anyway.  They are not measuring girth for some reason...which is unusual to me.   Even if it is unchanged, this is important to know, i'd think.

[newguy]

Thought this thread was about the UK Xiaflex trial, not an opportunity for Worriedguy and newguy to have a pop at Xiaflex!

I was simply commenting on Dr Lues words in the video. By no means am I stating that I think Xiaflex is a bad idea. If I thought that I wouldn't have created this very thread . WorriedGuy isn't anti either. I think he tried to get on the trial. I'll keep my future xiaflex comments (even replies) out of this particulalr thread unless they are specific to the UK trials.

[Worried Guy]

smithgareth,

Hey there, I'm not knocking Xiaflex at all and the reason I posted it on here was because I had asked if they were measuring girth during the UK trail.   A thinner penis could create a hinge so yes it could be a problem.  I'm sorry if this video was ill considered and I have highlighted a concern that was perhaps something you did not want to hear about at the moment.  I understand that you may have your own concerns already.  The fact is that Dr Lue wrote the book on peyronie's so I'm interested in listening to the guy.  I was told that if I had visited my Uro a few weeks before I may have gone on the trial and that if this trial is a success there is a good chance I will be getting it after it is cleared.  I probably will risk Xiaflex but will be sure to take girth measurements myself.  Also, because I'm not on the trial I've not been warned first hand about the dangers and this was the first I'd heard of it.  He did say that these were minor issues but this is why it is a trial as you know.  I really do wish all the best for the guys on the trial.  So far people seem to be having positive results so lets hope they continue.  I'm honestly sorry if I annoyed you.

[Worried Guy]

Mikesmith,

I did consider that also.  If you can get rid of the scar it will allow the area to expand.  In the lab it seems like it only dissolves the scar and leaves elastin.  I read that from one of the posts on here.  

[BSSS]

I don't necessarily think Lue is totally correct about what he says about the elasticity, or maybe I misunderstood him. How could one improve in length at all if no change in elasticity takes place? Just from angle improvement?  

[Luciano]

I don't necessarily think Lue is totally correct about what he says about the elasticity, or maybe I misunderstood him. How could one improve in length at all if no change in elasticity takes place? Just from angle improvement?

If I understand him correctly he says:
The problem is the loss of elasticity. So once the scar tissue is softened, you need some stretching, either physically (i think he meens modelling) or with a device (probably tranction or ved ? no idea)

Luc

[smithgareth]

Not looking forward to Friday, not sure there is any noticeable improvement, and not looking forward to a weekend of pain!!

[Worried Guy]

Good luck!

[waitingforxiaflex]

Hi All,

Like Gareth said, cycle 2 of the St. Peter's Andrology Centre Collagenase trial starts on Friday 20th May 2011.

By my measurements, I  have gone from a 30 degree deviation to roughly an 18 degree deviation after one cycle.

I will post the official improvement once known.

The "12 degree" improvement was noticed about 2 weeks after the first cycle once all the swelling had gone down and the daily home modelling sessions appear to have made no difference on the deviation (although I guess they could have kept the improvement intact).

I do have new lumps in the tunica which are of some concern. I'm not sure whether these were due to the collagenase or due to the modelling session by the investigator which was very very painful.

I'm not sure whether these lumps will turn into something more sinister at a later date of whether the second cycle will smooth things out. I will report on this at a later date.

12 Degrees from one cycle seem to be one of the better results posted from these trials. Although I have had the disease for 8/9 years the plaque, although fibrous and feeling like a cord, has always been softish with no signs of calcification. Erections have also been better since cycle 1, with the head fully engorged.

So, after cycle one I am quite impressed with the results. Also, as I am still above 15 degrees deviation I qualify for another cycle which will hopefully bring me down to somewhere close to 5 degrees at which point I would be happy. It would have been gutting to be at 14/15 degrees deviation now and therefore not qualify for the next cycle.

It will be interesting to see whether the next cycle has a bigger/smaller/same impact as the first. On paper you could argue any of these possibilities.

So ahead lies a long weekend of severe pain, having a pumped up, extremely sore aubergine between my legs and 3 trips to London.

I think I had better get some good films in.


WFX

[smithgareth]

Thanks WFX you've made me feel better! Glad you've had a noticable improvement, hopefully the truth is better than my perception and I will post my results on Friday. I've also noticed better erections, feels that they are stronger and almost stretching the skin. Unfortunately I'm working over the weekend so no films for me, think I'm going to spend most of it sat at my desk, will probably have to claim a sore leg to save too many questions!!

[UK]

WFX/Gareth

I did read that they were also measuring flaccid length in the trial. If in fact you had a reduction in the first place and they did measure are you able to share those results?

My biggest issue is flaccid curvature which is a 3 times daily reminder of the disease, so is of interest to me what effect Xiaflex treatment might have in respect of that

thanks

[waitingforxiaflex]

WFX/Gareth

I did read that they were also measuring flaccid length in the trial. If in fact you had a reduction in the first place and they did measure are you able to share those results?

My biggest issue is flaccid curvature which is a 3 times daily reminder of the disease, so is of interest to me what effect Xiaflex treatment might have in respect of that

thanks

UK,

I have lost length as a result of the disease (I went from 7 3/4 inches to around 6) but has been largely mitigated by the use of a penis extender as I am back up to around 7 inches - I used an X4 labs one but Fastsize are probably just as good which I used for quite a few months in 2010. Anyway, stretched length before treatment was recorded as 14.5 cm by the investigator.

I will let you know if they measure and what the result was sometime in the next few days.

WFX

[waitingforxiaflex]

OK, so quite a lot to report.

I'll get myself out of the way first...
Reduction in deformity was confirmed from 30 degrees to 18, a 40% reduction after one cycle  
Stretched length was again measured and read 14.5cm - no change here.
At 18 degrees deformity I was coming close to not being eligible for the second cycle. The investigator checked and I just qualified.

The first injection of this cycle was probably the least painful of all so far (yesterday). However the second injection (today) was by far the most painful. This was partly due to the plaque being hard to find by the investigator requiring much manipulation (having an already very sore penis) and partly due to the needle feeling like it went deeper than usual into the penis. Swelling, bruising and pain post-injections this time round has not been quite as bad as the first time. It will be interesting to see if this translates to less curvature reduction.

Modelling is on Monday. My favourite.  



Anyway, during this cycle I had more of a chance to meet the other trialists (as we waited to have blood samples, blood pressure and heart rate taken) and so we were all able to compare notes and talk about our experiences of the condition in a very amusing, enjoyable and frank matter. We all agreed this was the first time we had all done this as it's not the subject you bring up with your friends and found this to be an unexpected benefit of the trial. Highlights from our discussions... Improvements in curvature from cycle one varied quite widely. From the trialists I spoke to, 'The Champ' was a trialist with a 20-25 degree reduction from 75. We were all quite blown away by this. Another trialist had a 15 degree reduction, a few trialists had 5-10 degrees and a few had negligible improvements. Some trialists also mentioned that they had improvements in stretched length too. As for pain and swelling, some people had more swelling this time than last time, some less. Some found the second injection of this cycle more painful, some the first. It all seemed to vary with no pattern.

Finally, the centre has recruited another wave of 10 patients which is due to start in June. I did ask whether they had any free spaces but they said that they were fully booked.

I hope this helps.

WFX

[UK]

Anyway, during this cycle I had more of a chance to meet the other trialists (as we waited to have blood samples, blood pressure and heart rate taken) and so we were all able to compare notes and talk about our experiences of the condition in a very amusing, enjoyable and frank matter.

Heart Rate LOL - what they measuring there - who has the biggest fear of needles? :-)

Thanks for the report.

[Worried Guy]

WFX,

Thanks for the update.  Some pretty amazing improvements for some people.  Speaking to the guys was the general feel that people were improving more than they anticipated?  Did you ask about the new lumps which have formed and has anyone seen improvements in girth?

Cheers

[newguy]

Some great improvements guys. If these improvements stand the teest of time this is definitely an important weapon in the peyronie's arsenal.

[smithgareth]

Hi Folks,
sorry I didn't post on Friday unfortunately I haven't been well. I had an increase in stretched length of 0.5cm but no change in curvature. WFX was among a group who'd had noticable improvements and it just shows how hit and miss trials can be. My plaque is a little unususal I believe in that it's moved from when I first developed Peyronnies and now sits a few centimetres away from the curvature so on my second injection of cycle 2 Amr decided to leave the plaque and inject at two points on the curvature, running along the curvature rather than through the plaque. It'll be interesting to see the results from that.
Modelling was less painful this time but hopefully will produce better results.
Fingers crossed

[waitingforxiaflex]

OK so modelling was last night.

As previously mentioned - swelling, pain and bruising are significantly less this time round.

In fact, the investigator said that everyone showed less pain, bruising and swelling - possibly due to us all building up antibodies.


As there was no "angry aubergine" this time round, there was only very mild pain for the modelling procedure. The investigator used the same "force" as last time which in reality wasn't that much, it just seemed like it was last time as the penis was so sensitive. It's just really itchy today.

That's it for now.

[Worried Guy]

Fingers crossed for more improvements!!

[newguy]

ACT FAST. Mandi at Andrology UK sent me this email earlier today, asking to get the word out. Basically they are looking for a few people to take part in the next Collagenese trial VERY SOON, with treatment starting on the 10th June for those who they fulfill the criteria. Very limited places. Express your interest at mandi@andrology.co.uk

[shrout]

Many thanks Newguy.

I have acted fast and registered my interest (again!), although, not currently being able to satisfy condition No.2, I'm not particularly optimistic about my chances. Keeping my fingers crossed nevertheless.  

[Worried Guy]

What is condition number 2?

[Worried Guy]

I just checked.  You will have to tell a lie Shrout/Or have sex with a friend.

[shrout]

WG

2. Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse

http://clinicaltrials.gov/ct2/show/NCT01243411


EDIT: Dang, I already sent the email, in which I failed to lie (i.e.admitted the sad truth). Oh well...

[newguy]

Last heads up on this as I should think they've received a few responses. If you're in the UK and wish to take part in the Xiaflex trials next week, check a few posts down for mandis email address and contact her expressing your interest!

[BSSS]

WG

2. Be in a stable relationship with a female partner/spouse for at least 3 months before screening and be willing to have vaginal intercourse with that partner/spouse

http://clinicaltrials.gov/ct2/show/NCT01243411


EDIT: Dang, I already sent the email, in which I failed to lie (i.e.admitted the sad truth). Oh well...

Shrout,

How would anyone actually check to see if you are having relations with a female? (hint...they won't be able to)

BSSS

[shrout]

BSSS, you're right. Unfortunately I didn't realise this until too late and it looks like I've blown my chance. The more I think about this condition the more ridiculous (and unfair) it seems. So be it.

Still, it's not about me..  it's about the trial, and the outcomes, and a potentially powerful weapon in the war against this horrible disease, and, hopefully, an end to the suffering of thousands of men. I'll be following with great interest.

In the meantime, it's back to the VED  

[smithgareth]

Two weeks to go to round three ding ding! Looking forward to it as I think my curve is about 25% reduced so hopefully down to about 40 ish degrees! Fingers crossed!

[Worried Guy]

How was the pain and swelling in round 2?  Things seem to be going well for you. Have you managed to speak to the others?

[fubar]

That's awesome smithgareth I wish you luck for round three!

[smithgareth]

Sorry I've not posted earlier, busy few days. Measurement on Friday shows curvature down to 40 degrees!! Following the injection on Friday I had a popping/ cracking sensation during the night and when Amr did the modelling last night he said something had changed. He got a ruler and my stretched length is up nearly 2cm!!! Just need to see how things settle down now and see if the curve has changed too!

[Worried Guy]

Strange.  What do you think happened? Have you noticed a reduction in plaque size?  Amr told me during my last appointment that the study was looking positive but it was too soon to tell at the moment.  I look forward to reading it once it is published.  He did say it would be a few years until it is available to the public.  It concerns me with all the cuts at the moment that nice will he not pass if for the NHS.

[smithgareth]

My guess is the plaque split?? Does that sound plausible? Just want to see what the curvature is like now, but I'm not sure I'm ready to find out yet!!

[Worried Guy]

Do you know how big your plaque is?  Did they tell you?

[MUSICMAN]

When you can hear or feel the crack or snapping sound, it is the plaque breaking up. That is a good thing. If you think of the plaque as a cord, what is happening is that the cord is breaking. I don't think it happens to all and you can still have change even if you don't hear or feel something.

[veryworriedguyuk]

I do hope this trial will open up to people with hourglass deformity. I'd give anything right now to be on the trial, I know we all have varying degrees of the same problem but at 26 it's a nightmare. When you next visit Amr would it be wrong to ask for you to casually inquire how the treatment would work for people with hourglass deformity. Hope all is going well for you though

[waitingforxiaflex]

Hi,

An update from me on this UK trial...

The 2nd cycle that took place in May produced no change in curvature or stretched length.

If you remember I went from just over 30 degrees to 18 degrees after the 1st cycle.

The weekend that just passed was for the measurements from the 3rd cycle (early July injections) and injections for the 4th cycle.

My measurements as a result of the 3rd cycle injections are now 13-15 degrees depending on erection strength.

My stretched length has now gone to 16cm from 14.5cm.

The study co-ordinator was of the opinion that the treatment should now stop, which I agreed with.

So 13-15 degrees is a noticeable curvature but of a more cosmetic concern than a functional one.

So I'm pretty happy with the result overall - worth the wait  


Finally, speaking to the other participants, a number of people  have reduced their curvature by roughly 40-50% over 3 cycles. I didn't get a chance to speak to everyone but of those I did, a 45 degree improvement (started with 90) was the best result, and in this instance if I remember rightly, he had only a very small improvement after the first cycle.


Waited For Xiaflex  

[newguy]

Thanks so much for the feedback. This is starting to sound really promising if your experience and that of the others you spoke to is anything to go by.

[shrout]

Yes, some very encouraging stories from the trials on both sides of the Pond.   Thanks to all participants who took the time to post their experiences and results.

[veryworriedguyuk]

Any update guys?

I'm hoping for positive news from you all. I cannot wait for this drug to made public. I just want a cure for this awful condition.

veryworriedguy

[John]

My first post on the forum. Have suffered with Peyronies for 7 years and am very excited about Xiaflex. As a result of New Guy's posts in June I emailed Mandi at Andrology UK. Very excited as within 48 hours I travelled to London to the Clinic for assessment for the trial. Very disappointed as I did not satisfy the criteria due to the fact my plaque was too hard or calcified. The doctor explained the needles used were fine like Insulin needles and Auxilium did not want to run the risk of a needle break on the trial. So now I am hoping Xiaflex will be approved and I can pay for treatment. I hope the hardness of the plaque will not be a bar to treatment.

[newguy]

My first post on the forum. Have suffered with Peyronies for 7 years and am very excited about Xiaflex. As a result of New Guy's posts in June I emailed Mandi at Andrology UK. Very excited as within 48 hours I travelled to London to the Clinic for assessment for the trial. Very disappointed as I did not satisfy the criteria due to the fact my plaque was too hard or calcified. The doctor explained the needles used were fine like Insulin needles and Auxilium did not want to run the risk of a needle break on the trial. So now I am hoping Xiaflex will be approved and I can pay for treatment. I hope the hardness of the plaque will not be a bar to treatment.

Thanks for your contribution. Pentoxifylline has a good track record for removing calcification. If you're not taking it already, perhaps doing so might mean that somewhere down the line you're suitable for xiaflex?

[John]

Thanks newguy. I've never tried Pentoxifylline but will do so and will report the outcome.

[waitingforxiaflex]

So, it's about a year since I had my last round of injections. Deformity has kept to around the 12 degree mark and any concerns are entirely of a cosmetic nature. I was worried that the curve would worsen again but touch wood, that doesn't seemed to have happened :-)  

[james1947]

waitingforxiaflex

Thank you for the update. It may encourage people that are waiting for the Xiaflex.
It is very encouraging that your deformity is 12 degree after almost a year from the Xiaflex treatment.

James

[tunnelman]

Anyone on here that has received Xiaflex through Mr Ralph and his team in the last Xiaflex trial who could write about their experience in terms of the procedures and outcome?

Many thanks

T

[james1947]

A small search and I got:
UK Xiaflex Trials - Peyronies Society Forums
You may want to read it until you will get some concrete answer.

James  

[paul warwick thompson]

I am a private patient of Mr Ralph's and have been waiting since February 2014 to go onto the UK Xiaflex trials. Does any member out there know what the status of Xiaflex is in the UK?