RestoreX Trial Data Results

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WhatNext81

https://www.sciencedirect.com/science/article/pii/S0022534718427474

I'm not sure if this was posted in a thread, but I didn't see a new thread with this link.
Read it! It's promising!  
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betterbend

Very promising preliminary results ...  Besides some minor issues I am very happy I switched over to this device from the Andropeyronie.  I paid for it through my FSA account, but still awaiting a final decision of approval from them.  I dont think there will be an issue....
55 - Onset May 2017.  38 degree bend up.  Failed Xiaflex treatment.  Still functional so I decided to stop treatments.  Only take 400mg Co-Q10 and occasionally use Restorex

alec

this really sounds great... if you wear it another 3 months.. the curve would be gone?  
30yrs, diagnosed in feb. 2018 after possible injury (not sure), 4 plaques, 4 dents, S-surve, 30° right/45° up curve, tingle in the legs, sometimes penile pain an depressed.

betterbend

No, it definitely does not mean that.  Understand a few things about this study.  This is for 38 patients, that is a small group, you want to wait for a bigger sample reporting to start to draw conclusions.  Also, when they say the % change is -43%, that is the average, or the mean for the entire group.  Some patients were above 43% and some below.  There may be men in the group that had no change or even got worse.  This is an average result.

This is very encouraging initial data.  I would expect that entire published study will be very positive also.  But there are always people in a group that dont respond at all, and you cant draw a linear line that in 3 months 43%, therefore in six months 86%.  The human body doesnt work that way...

Full disclosure though, I bought the Restorex and am hoping for this type of result :)
55 - Onset May 2017.  38 degree bend up.  Failed Xiaflex treatment.  Still functional so I decided to stop treatments.  Only take 400mg Co-Q10 and occasionally use Restorex

alec

makes sense... are the people that built it the same that made the study? I have the feeling a lot of people making lots of money with our hopes here...
30yrs, diagnosed in feb. 2018 after possible injury (not sure), 4 plaques, 4 dents, S-surve, 30° right/45° up curve, tingle in the legs, sometimes penile pain an depressed.

betterbend

Yes ... but that doesnt mean its bad.  You look for certain things in a medical research study to tell if its a good study.  Large sample size (improved statistical data), randomization (meaning not cherry picking good patients), double-blind (not possible with this study), & control group.  Those elements can remove biases.  The best thing is when unrelated doctor or hospital tries the same study and get similar results.  Then you really have something ...

But you are smart to question the motivation of the study... but if people were not making money, then there would be nobody to pay for studies, so you have to accept that ...
55 - Onset May 2017.  38 degree bend up.  Failed Xiaflex treatment.  Still functional so I decided to stop treatments.  Only take 400mg Co-Q10 and occasionally use Restorex

WhatNext81

Keep in mind there are two parties involved with the device. Mayo Clinic has very high standards. They are a very well respected and reputable clinic with patients from all over the globe for a reason. Also, this is an early release as patient data is looking very positive. It takes a lot of work to get stuff like this published. They're eager for a reason. More exciting and promising stuff in the works by the end of the year.  
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TonySa

I wish they reported the differences in improvement between the 30, 60 & 90 minute groups.  I'm going to email and ask.
PxD 2 yrs 9/16.  Failed all treatment. 9/11/18: excision, grafting & implant Dr Karpman MtnView Ca, AMS CX 18cm + 3-1cm RTEs.
Pump failed.  2/11/20 Dr Karpman installed Titan 22cm +1cm RTE.

WhatNext81

That would be nice to know, Tsanchez. I stuck with 60 mins just because I was using closer to 5-6lbs of traction and long term effects is what I was more concerned about.

They discussed some randomized stats with me and I think Tsanchez received an email in regards. That was back in feb, I think. It was only 3 ppl if memory serves me right. Either way, it seems promising and that's positive. I went from 30 degrees to 0. I really hope more people achieve great results as well. Really really am hoping!  
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TonySa

30 to 0 degrees with 60 mins a day, how many months did it take?
PxD 2 yrs 9/16.  Failed all treatment. 9/11/18: excision, grafting & implant Dr Karpman MtnView Ca, AMS CX 18cm + 3-1cm RTEs.
Pump failed.  2/11/20 Dr Karpman installed Titan 22cm +1cm RTE.

WhatNext81

October until my final evaluation on April 5th. Give or take a day. I also regained a total of just under 2" in lost length. Keep in mind I was also undergoing xiaflex treatments during this time. But, injections don't do anything for lost length.
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skunkworks

Now this is the sort of thing I like to see.

Hopefully the full study will show force of traction used?

QuoteI wish they reported the differences in improvement between the 30, 60 & 90 minute groups.  I'm going to email and ask.

Yeah this is very important info, but it would be in the data tables when they post the full thing no doubt.

This line in the study is untrue though:

However, existing PTT devices require daily utilization for 5 or more hours and have failed to consistently demonstrate significant improvements in penile curvature or length.

The studies on conventional traction devices have been quite consistent in their results when you even out the hours of use.
This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

WhatNext81

Quote from: skunkworks on April 27, 2018, 11:34:34 PM
Hopefully the full study will show force of traction used?

This line in the study is untrue though:
However, existing PTT devices require daily utilization for 5 or more hours and have failed to consistently demonstrate significant improvements in penile curvature or length.

Highly unlikely.
You should email them and see how they came to this conclusion. It would be interesting to find out.
What traction device did you use to correct your curvature?

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skunkworks

Already did, awaiting reply.

Fastsize, not available anymore but no different to most available now. Only difference was they supplied very soft and grippy silicone nooses, which mean you can get a solid attachment with a looser noose.

Anyway, preliminary data above does look promising. I don't know why force used would be 'highly unlikely' to be included, if the device is standard and the users stick with a particular setting, it would not be hard data to get.
This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

WhatNext81

Comb through what other users are saying. If you were to use the device, I think you'd understand.

How many months/hours did the fatsize take to fix your curve? Was it designed to bend in all directions? What was the maximum force it was able to apply? Is there a study on it?  
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WhatNext81

Found this after sifting through a bunch of negative info.

https://www.ncbi.nlm.nih.gov/m/pubmed/18452379/

Other websites said the FDA had it pulled as the company was making medical claims not approved by the FDA.  
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skunkworks

Fastsize is exactly the same as x4, sizegenetics, andropenis, jes extender, proextender etc They're the same thing, the studies on any of them apply to all of them.

This thread is about Restorex though, why are you asking about Fastsize? Stay on topic.
This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

skunkworks

Quote from: WhatNext81 on April 28, 2018, 01:42:28 PM
Comb through what other users are saying. If you were to use the device, I think you'd understand.

It operates the same as most other spring loaded devices, adjustable tension with marks to measure, so the tension at a mark/line should be standard. Just as I know what tension I am at using a traditional device, the user of Restorex should know also.

Have you measured what tension your device delivers at at each mark/line/dot ?
This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

WhatNext81

You mentioned you had used it so I was courious. Should I start another thread to ask what your expierence and improvements made with it were? I'm also curious what they claimed that got it pulled.

In regards to RestoreX, I've posted pictures showing tension at around the white line being 3lbs. You can bury the white line as far as your comfortable with. The notches on the extension rods aren't indicators for the amount of tension applied, but they do increase the tension. The variable
here is the length of your penis. Watch the video again and you might understand it. White line=3lbs. Just out of the locked position is around 7lbs. Does it say in the trial info if participants are to keep track?

For detailed answers, probably just keep emailing them and wait until more trial data is released.
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skunkworks

Yeah no worries, I am totally fine with 'I don't know' as an answer. I have been talking to someone from the team via email, I will ask if he can come here and answer the more detailed questions about the device.
This is an emotionally destructive condition, we all have it, let's be nice to each other.

Review of current treatment options by Levine and Sherer]

WhatNext81

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radiantblue

60 minutes per day? Sounds too good to be true. I am excited though.

So if you only have to use it for 60 mins per day, what makes it different to other devices?

Is it simply higher force for shorter time?

Also interesting that the average time since peyronies onset was 1.5 years approx. I guess that means most participants were in the stable phase.

I usually hear that traction works best in the active phase.

swiss

I couldnt use traction in the active phase. It was too painful and triggered more inflammation for me. I had to wait until stable with little pain. I wish I had done light traction by hand though in the active phase though!

BlueRobot

Of note, this other study with rats lends evidence to 60 minutes a day of traction producing results in 4 weeks.

[update]
Note this is not the Mayo study that started the discussion. This a a separate study that relates to some of the questions posted.

https://www.ncbi.nlm.nih.gov/pubmed/28923308

betterbend

Curious to see how they traction a rats penis, or who gets the VED task on a rat ...
55 - Onset May 2017.  38 degree bend up.  Failed Xiaflex treatment.  Still functional so I decided to stop treatments.  Only take 400mg Co-Q10 and occasionally use Restorex

WhatNext81

Quote from: BlueRobot on May 02, 2018, 09:51:36 PM
Of note this study (previously posted on the forum) with rats lends evidence to 60 minutes a day of traction producing results in 4 weeks.

https://www.ncbi.nlm.nih.gov/pubmed/28923308

This isn't a Mayo study. The original post/thread is about a Mayo study. This could be misleading to some. Mods? Where you at?
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BlueRobot

@WhatNext18

Good catch. I updated my post to hopefully make this more clear.  

WhatNext81

Trial info is coming in and a majority are showing improvements in deformities including indentations and hourglassing.  
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WhatNext81

Shipping is now available to Puerto Rico
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Pfract

That is very good to know! Any idea of when shipping to Europe is going to be available?  

WhatNext81

Unfortunately,  I'm not sure. I got the shipping info from the website.  
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radiantblue

Ill be buying if they ever ship to AU. Wonder if shipping through an exporting company would work?  

Hawk

First, let's establish the fact that that there have been NO clinical trials that compare Restorex to other traction devices.  The fact that a urologist that happened to work at some specific hospital and later developed and marketed a product does NOT mean that product is endorsed by any hospital.  On its face, it certainly is not proof it works any better than existing solutions.  For that, you need independent, large-scale, randomized trials.

Next, let's look at the theory behind it.  As I understand it, the idea is if your penis bends to the right then bending it to the left under traction will somehow stretch the shortened fibers or tissue more than a straight pull.  This is utterly illogical and in my mind, has the earmarks of a gimmick.

Let's say your penis was 6" and the tissue on the right was replaced with scar tissue that caused a curve to the right.  When you try to stretch your flaccid penis now you can only stretch it to 5".  Ask yourself why you can only stretch it 5" instead of the original 6".  The answer is clearly because the non-elastic scar tissue on the right is restricting further stretching.  In other words, the scar tissue on the right is stretched to its full capacity of 5" long before the normal tissue on the rest of the penis can begin to reach its full stretch.  If you were to try to stretch it under force to 5.25 inches, 100% of that torque would be FOCUSED on the scar tissue on the right side of the penis.  None of that torque would be placed on the tissue on the left side of the penis that is still far under its maximum stretch length.

FACT: You can place enough torque on the penis with traction to actually cause discomfort, pain, and even tearing.  Pulling the penis at an angle or around a corner is not going to place any more focus on the scar tissue and it will not apply any more torque to the scar tissue than any standard traction device.

None of this even addresses hour-glass deformity or the typical Peyronies Disease penis that has plaque distributed in more than one area of the penis.  Standard traction focuses on the shortest, most limited side of the penis PERIOD.  To illustrate this all you have to do is to hook 5 rubber-bands of different lengths over your finger and side a pencil through them and stretch.  The shortest bands are under stretch tension before the longer bands even have the slack pulled out of them.  Pulling them around a corner is NOT going to change that!  You can illustrate the same thing with scotch tape (representing scar tissue) on a ballon.  Stretch the deflated balloon in a straight line and the torque is placed on the tape.  Stretching around a corner is a gimmick with zero proof it is an improvement and zero logic to support it.
Prostatectomy 2004, radiation 2009, currently 70 yrs old
After pills, injections, VED - Dr Eid, Titan 22cm implant 8/7/18
Hawk - Updated 10/27/18 - Peyronies Society Forums

WhatNext81

Quote from: Alexander88 on April 27, 2018, 11:50:45 AM
makes sense... are the people that built it the same that made the study? I have the feeling a lot of people making lots of money with our hopes here...

"Mayo Clinic and its staff often collaborate with industry to improve patient care through research agreements, invention licenses and consulting activities. The Mayo Clinic Conflict of Interest Review Board oversees all such activities. Mayo Clinic and its staff members do not receive any royalties for inventions or technology developed at Mayo and subsequently prescribed for Mayo Clinic patients."
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WhatNext81

Yes. As far as we know, it hasn't been tested against other traction devices. It's a new device that is still undergoing clinical trials on it's own. Seems like a good starting point. I don't believe it has been mentioned that RestoreX is endorsed by any hospital. Also, I don't believe the product is marketed by any Dr. The product became available in October, so it is logical to come to the conclusion that there hasn't been enough time to prove that it works better than any existing solutions. Large independent studies are needed for that kind of proof, and again, that takes time. The clinic appears to have a nice list of affiliations and is quite active all over the globe. I'm not saying that has anything directly to do with this study, but it sets the tone when you look at the bigger picture.  Now, we have very limited trial info, but it looks promising in my opinion.

As far as the theory behind it goes, it's not just left,right,up or down for curvature correction. Keep in mind that my understanding is simply anecdotal as a user, but the logic is apparent. The clamp location can be adjusted to three different locations to address the area of curvature more directly. These locations are based on measurements taken described in the instructions that come with the device. Given the different locations I have had to correct, I could/can feel the difference in the targeted location based upon the setup. To test it, I have moved it to a different spot, after using it in the correct location(15mins per insturctions), and I could feel the tension more in a different location, while bending.

Regarding the 6" penis with scar tissue on the right and only stretching to 5"...isn't the point to break up the tissue and help regenerate healthy tissue, which traction has proven effective? And as it breaks up, becomes more elastic, form-able, etc- through time under tension, everything stretches out, eventually leading to torque being placed evenly on both sides? Assuming we are talking about a standard straight stretch with the 6" and 5" scenario you've given. If the curve is corrected, you'd be back to 6" and even torque. The bending against would be more effective, especially if it's more localized. Same concept as hand modeling with xiaflex treatments.

"FACT: You can place enough torque on the penis with traction to actually cause discomfort, pain, and even tearing..."  

Anyone who has used traction has a basic understanding of this concept. And, as stated above, I feel this is where there is a difference. But, you're entitled to your opinion.

I had hour-glassing and a dent, upon starting traction. I also lost sensation in the area where it buckled. My hour-glassing is gone and I have regained sensation as well. The original dent also went away.  I have recently developed a new, small dent, and have been instructed to start up regular traction again. Now, was hour-glassing and the dent corrected due to the device alone? I believe it helped, along with generic viagra at bedtime.

This is to be taken lightly, but I'd hope a little more science and engineering went into this than a Jr. High science lab day. I understand your logic with rubber bands, a balloon and some tape. I don't feel it holds as much weight.

Now, you can check out for yourself how this clinic operates. I'm not saying I fully understand it, as it is very complex. Funding, Drs, scientists, trials, data, and their objective to overall health and science and contributions to so many things dating back well over a century. They've helped the military in many ways that are rather surprising. Remember the anthrax scare? Their biomedical team developed a DNA test that could identify someone affected in under an hour. Existing tests took 1-3 days for results. They sent this out regionally for free. It also was developed to eliminate having samples sent to other labs for diagnosis. And it was done fast. That's just one thing and there's plenty more impressive public contributions just a google search away.

For all of their contributions and successes, I find remarks such as "a gimmick" and "illogical" to be, well, illogical. I'm not saying this is the right device. It could be a flop. It could also be a real success. It could also be the right step with great things to come in terms of non-invasive, at home therapy. Time will tell. It's still very early in the game.
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jusirmi

we must be cautious with this device until the clinical trials finish. however, at first of may appeared two new clinical trial in clinical trial.gov testing this device for prostatectomy and pre implant to restore length loss in this disease. I think that this is a good sing that they have seen a good preliminar results in peyronie's. The study of peyronie's seems well designed with a control group, double blind and randomized all the standard for clinical trials, in addition, they will used 120 patient and they will ask them if this treatment is better than the other treatments and penile traction devices.
Nevertheless, i have also some doubt about it, for example is the traction force too much for some patients, could worse the pathology in this subgroup, could increase the risk of some vein pathologies, we don't know yet, and as exclusion criteria they did not accept people with a calcification of grade III what this people could do. In addition at least in this abstract the 75% of the people take collagenase and this could influence the results. However, i'm happy that someone is trying to improve our disease.

Paolo

Agreed, for now Xiaflex remains the 'Gold' standard for peyronie's  :)
Whenever you find yourself on the side of the majority, it is time to pause and reflect.

betterbend

Actually surgery is the gold standard, provides the most sure correction.  We hope to find a less invasive means of curing Peyronies.  Xiaflex is not it, unfortunately.  Traction is also used in conjunction with Xiaflex to improve results.  
55 - Onset May 2017.  38 degree bend up.  Failed Xiaflex treatment.  Still functional so I decided to stop treatments.  Only take 400mg Co-Q10 and occasionally use Restorex

TonySa

Better bend, which surgery are you referring to, plication?  If so, very successful but significant shortening hence so many opt for xiaflex.
PxD 2 yrs 9/16.  Failed all treatment. 9/11/18: excision, grafting & implant Dr Karpman MtnView Ca, AMS CX 18cm + 3-1cm RTEs.
Pump failed.  2/11/20 Dr Karpman installed Titan 22cm +1cm RTE.

tiagofil

That's what they say. I guess Urologist associations have a pretty low opinion on gold?

Penile shortening, postoperative ED, decreased penile sensation, recurrent curvature, this all in a significant percentage of cases. Then theres the lower ocurrencies like infection, hematoma and urethral injury.

Anyway economy left the gold standard many decades ago..... Heh!

WhatNext81

Quote from: tiagofil on May 17, 2018, 11:32:51 AM
Anyway economy left the gold standard many decades ago..... Heh!

Haha! I see what you did there.
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