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[Mending the Bend]

Now recruiting in the UK, for people with Peyronies Disease that haven't tried other treatments yet (AA4500 is collagenase):

An Open-label Study to Assess the Safety and Effectiveness of AA4500 in Combination With the ErecAid® Esteem® Manual Vacuum Therapy System in Treating Men With Peyronie's Disease

https://clinicaltrials.gov/ct2/show/NCT02267460

[NeoV]

Very interesting. If there's one thing to be realized its that studying Peyronie's is one of the hardest things I could imagine. My bend changes on a daily basis, depending on multiple factors. Still we have to follow the studies and do what we can.

[Ive]

To avoid disappointment, can I alert people to the fact that the UK Trial listed below is now closed and cannot take any further applicants.

There is no point, therefore, in contacting Sara Richardson.

Thanks.

[TomThumb]

Quote deleted by moderator - James
Please read the forum rules!!!

Hi everyone. New here, but thought I'd give UK based guys an update which they may find helpful

It is true that the trial application is closed and they are not taking any more applicants. There are over 100 on the waiting list waiting for about 30 places on the trial. I believe they will be starting the selection process for these imminently.

Having said all this, I have now been informed that Xiaflex has now been approved in the UK for the treatment of Peyronie's. Although NICE haven't approved it yet for use on the NHS, it is available privately. It is likely to be about £5000 for the whole treatment including VED. I know this is a lot of money, but for some I know they would find some how to pay for it if there was a possibility of being treated.
I hope this helps.

[james1947]

TomThumb

Can you give us some more information regarding your Peyronies/connection to Peyronies?

James

[TomThumb]

Quote deleted by moderator - James
You are continuing with the forum rules violations!!! Why?

Hi James.

I was diagnosed 20 months ago, 2 months after I first had symptoms. I have been attending a clinic in London ever since and have been on the Xiaflex UK trial waiting list for about 10 months. My peyronie's has been stable from about month 2, but it hasn't got any better either. The trial start date has been delayed a couple of times so I am hoping it will happen soon.

[Ive]

Hi TomThumb

Good luck with the trial. Hope you hear something very soon.

Just to add, although this is a long way from fruition, that there is some discussion that the NHS might take on Xiaflex injections as an alternative to operations. For some (usually over 40 degrees) operations are granted on the NHS. As operations are much more expensive than a cycle of injections it is not rocket science to see why the NHS are considering this.

Like I said though it is a long way in the future if it ever happens.

[TomThumb]

Sorry, I appear to have broke a golden rule of the forum -Twice! Apologies James, I understand now.

Thanks Ive for your good wishes.

The most up to date news that I have is that trial is producing some amazing results with complete curvature correction in some patients from both arms of the trial.

I can't help but agree: the cost of xiaflex as opposed to the cost of operations and the risk of complications and unsatisfactory results must be a large consideration. NICE has never been one to move quickly on anything, so I don't suppose it will be approved for NHS use anytime soon, but there is still hope.

I'm happy to give details of my experience if others will find this useful. Any questions please feel free to ask, I'll do my best to answer.

Tom

[Ive]

The most up to date news that I have is that trial is producing some amazing results with complete curvature correction in some patients from both arms of the trial.

Which trial are you referring to here TomThumb? Do you mean the one Andrology are currently running/just finishing?

[james1947]

For me TomThumb, every rule is a golden rule.
This is how we keep this forum as it is, for the benefit of all the Peyronies sufferers.

James

[Ive]

The most up to date news that I have is that trial is producing some amazing results with complete curvature correction in some patients from both arms of the trial.

Can I ask again TomThumb, which trial are you referring to in this statement and what do you mean by both arms of the trial? Do you mean the one Andrology are currently running/just finishing?

[TomThumb]

Hi Ive, this trial is the one being run in London for 30 participants by Auxilium Pharmaceuticals. I believe that the trial involves half the patients having 'remodelling' in addition to the xiaflex injections and VED therapy, so that is one 'arm' of the study. The other arm of the study is patients just having xiaflex and VED therapy without any remodelling. The idea therefore is to see if remodelling offers any additional benefit with the use of combined xiaflex and VED therapy.

[TomThumb]

Just an update on my experience with the Xiaflex/VED trial. As I posted a few days ago, I have discovered that indeed there are 2 arms to the study, one with remodelling and one without. I have had my screening and it was confirmed that I am eligible for the trial and would be starting shortly. According to the study details (they provided me with 18 pages of information in the clinic!) the trial will begin no longer than 3 weeks after screening has taken place, so I should be starting any time soon. I'm not sure if anyone is interested but I have a treatment schedule showing what happens and when during the trial and I could scan it and post it on here -it requires up to a total of 19 visits to the clinic depending on which arm you happen to be randomised onto, so quite a commitment.

That's all for now. Tom.

[james1947]

TomThumb

Definitely all of us are interested if you will post your experience with the treatment, detailed as possible.
Please open a new topic to post your experience.
Good luck with the treatment, wish you excellent results.

James

[Ive]

Hi Ive, this trial is the one being run in London for 30 participants by Auxilium Pharmaceuticals.

I think you are referring to the one that is just about to start yes?

How can you say, therefore, that trial is producing some amazing results with complete curvature correction in some patients from both arms of the trial if it hasn't actually started yet?

If you are referring to the one that is just finishing, then your information is very much incorrect..

Please clarify. Thanks.

[TomThumb]

This is a new trial that has started recently. I am told that as soon as participants had passed their screening, they started on the trial almost straight away. I am simply quoting what I have been told by those conducting the study, who I presume are best equipped to comment on such things. Sorry, if your trial experience hasn't been a good one, although I expect full results may take some time.

[Ive]

Aggh!

TomThumb.

The trial that has been started recently is the one you are on. There has been no other in between the one I am just finishing and the one you are starting.

I too have the information from those conducting the trial and have been with them for six months.

I did not say my trial has not been successful, far from it, just that your comment about complete curvature correction from both arms of the trial is inaccurate.

I appreciate your enthusiasm for the trial and hope you will find it as successful as I have done, but I do think you should be careful about giving people possible over expectations especially when the information is not correct. What I think is important here is to emphasise is that Xiapex is not a quick fix cure. It needs the participants on the trial to follow the instructions and stick with it. You will hit more than one wall during the trial and need to motivate yourself to carry on. But do it and it will be worth it.  Please ask me if you have any queries.

Once again, I wish you well on the trial. You will find them a great team and I repeat stick with it for the best results!

[TomThumb]

Ive, thank you for your less than polite reply!

"Aggh!" What kind of a response it that? Not a courteous one, nor one that is merited.

My posting was not about my enthusiasm for anything, I quoted what I had been told. It was anecdotal as often these things are, and anyone who reads these threads will be aware that there are good and bad results and there are so many variables that contribute to outcomes. I cannot comment on what you have been told or who you spoke to, but I will continue to report my experience and what I know or have been told. I don't believe in filtering information just because someone on here suggests that I should say things in a different way or in the precise way that they would prefer. Good research discussion comes from a plurality of opinions, not one that is centrally controlled. I actually didn't suggest that Xiaflex was either a quick fix cure, far from it -in fact I posted the schedule to show that it wasn't and stated the commitment that it requires. For the record, I should explain that I am not naive to conducting clinical trials and know the team conducting this well, which is why I felt confident in quoting what I did.

Thank you for your good wishes, but it would have appeared more sincere had aspects of your reply been less barbed.

[james1947]

Ive

Asking you to keep a more polite ton while writing on the forum!!!
Personal attacks, even smartly hided, are not allowed on this forum.
Everyone can express his opinion, but in a polite and respectful way!!!

James

[Ive]

James and TomThumb.

Aggh! was an expression of frustration not an impolite or a personal attack as you have presumed.

Frustration because TomThumb quoted something that is factually incorrect and continued to do so; although he now concedes this was "anecdotal".

He quoted that a trial is producing some amazing results with complete curvature correction in some patients from both arms of the trial

On 7th March he stated that his trial would start in approximately three weeks so it cannot be this trial to which he is referring.

There is no other trial at Andrology apart from the one I am on which has not produced the results that TomThumb mentions but are very good nonetheless. This was not an opinion he was expressing but a fact that is incorrect, and, in my opinion, was not helpful to new people undertaking a trial which is why I wanted to put it right.

I am rather wishing I had not started this since people seem to be taking offence. However, I merely wished to clarify with TomThumb which trial he was referring to. Andrology have said to all trialists not to expect a quick fix or miracle cure. My intention was to make sure that new people did not go into a trial with an expectation of complete curvature reduction. Some may and that is great but it is certainly not the norm.

My intention was purely alturistic and not intended to annoy anyone. I confess my last post was perhaps badly worded but borne out by TomThumb failing to answer my question to which trial he was referring to on three occasions!

james I would also take TomThumb's comment I am simply quoting what I have been told by those conducting the study, who I presume are best equipped to comment on such things. to be patronising, and a personal attack, even smartly hided such as you mention.

In conclusion, I am extremely happy with the results of my trial (as are the other participants) with Andrology and would recommend them to anyone. Good luck to everyone on the new trial. I will publish my results in the first week of April.

[Ive]

Addendum:

The other point I would make is that Andrology will actually stop injections when and if a patient reaches a curvature of 15 degrees or less, so will not actually continue injecting to a complete curvature reduction.

Of course, that is not to say that there is a chance that curvature reduction may continue even after injections have ceased.

[TomThumb]

Ive, your reply is not worthy of any further response. I will leave others to decide whether your conduct has been appropriate.

To anyone else who is interested in my experience, I will continue to report it as fully and truthfully as I can. I recognise my fortunate position to be on the trial and hope in some way I can help others understand the process more fully, as I know this is often helpful. I hope it goes without saying, but the opinions I express and the experience I report are my own and no one else's, but I also respect that others may hold differing opinions or have had different experiences to me. In fact I welcome respectful robust discussion!

I will give details of my first cycle on the trial next week when things have settled down a bit. As always, happy to answer any questions.

Tom.

[james1947]

Yes TomThunb, your reports will help others.
Please post on the topic you have opened for the reports.

James

[Ive]

Thanks for your message TomThumb. I have replied.

All sorted now I hope and let's move onwards and upwards (so to speak!).

[hope4all]

phew...glad that was sorted out, guys.  I look forward to hearing more from both of you. I'm doing my own (unofficial) trial here in the U.S. along with several others on this board. Xiaflex with traction.

I started regular traction session after my 2nd round a few weeks ago. Too early to tell. When I was first dealt this hand 6 years ago, I ordered a Fast Size traction device, i hated it then, and hate it a little less now...now that I'm not the complete emotional mess I was then it's not so bad. The noose around the glans is still a little uncomfortable.

I have a three cylinder VED but I'm  more nervous about using that. I was thinking of using OldMan's 26 week VED protocol after the very last cycle of Xiaflex which is at the end of May...so several weeks after that, once the inflammation and discomfort have subsided.

At any rate, I look forward to hearing from you both, and thank you for sharing your unique experiences.
Hope4all

[Ive]

Thanks hope4all and good luck to you too.

I've always found the Somaerect Response VED to be the one for me.

It has a double cylinder which means that the erection is kept straight which must be good for stretching the plaque. Can't understand how others on the market which have a wider width are as good. Good vacuum but the penis starts to bend within the cylinder which seems pointless to me given what you're trying to achieve.

The Somaerect does have three cylinders but you don't have to use them all. Not promoting the product, just the one I prefer.

When you say unofficial, presumably you are getting the Xiaflex injections but the traction isn't part of the recommended treatment. Certainly injections with VED is the way things are going here. Although loads more data to collect, it looks from the trials like there is no significant difference between those using VED and those doing and receiving modelling.

[hope4all]

Thanks Ive. My doctor doesn't do modeling. I presume it's because he can't work it into his busy schedule. He's part of a University Hospital system and wears many hats..surgeries, office visits, hospital visits, and veteran's care. The guy is busy. He also happens to be a big proponent of Xiaflex unlike many of his colleagues. He told me many still recommend verapamil injections, something that made me wince, since for me it made my condition worse.

I have the 3 cylinder VED I purchased 6 years ago as part of my arsenal to treat this dreaded thing. I'll dust off the cobwebs from the VED and use it when I'm ready. I agree with you on the more narrow choice of cylinders.  It keeps it much straighter and makes more sense to me. It's also easier on my scrotum, as less of it gets sucked into the chamber when I use the smaller cylinder.

My UK TRIAL Xiapex result

Started by Voglin Xiaflex Injections

Stem Cell Clinical Trial

Started by Crooked_Stick Developmental Drugs & Treatments

Peyronie's Disease Clinical Trial

Started by FD_Study Awareness/Advocacy/Activism