In this episode, Dr. Rena Malik, MD sits down with Dr. Jesse Mills to explore the fascinating and transformative use of intralesional ...

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Bent Penis? Fix it (no surgery!) with This Proven Peyronie&#39;s Disease Treatment!

let's talk about interlesional collagenase yeah let's talk about this this um interesting enzyme so collagenase is a it's a flesh eating bacteria and it comes from a claustrum biomolecule so it's a bacteria and and its job in the bacterial setting is to just destroy collagen so that the infection can spread right through any part of your tissue any part of your body that has collagen what has a lot of collagen your skin that's what makes a nice and bouny and as we get older not so bouncy when we lose collagen so collagenase is amazing it just rips through but not all collagenase is the same there's I mean if anybody spent any time in a basic science lab you can just pull it off your shelf and make it up for you any one of your experiments to to to render protein so you're looking for the the DNA you're looking for you throw some collagenase in get rid of the protein there's your DNA so collagenase is multiple different Aces and anything that ends an ace is just an enzyme and so the behind this was actually goes back to a good friend of mine uh dear dear friend of mine Marty gelbard when he was a resident at UCLA in the 1980s who his resident project for the year for the research year UCLA was thinking about this collagen and ponies who was very interested in it which at the time very few urologists were but for some reason took a shine to thinking about this condition that was really an orphan condition and he knew the plastic surgeon surgery guys were using a for scar reformation and significant soften cutaneous scars and you say well jeez that's what ponis is it's a scar it's in the penis but it's still a scar and that sort of led to the groundwork for a lot of research that then eventually led to knowing exactly what types of col collagen are most in a prony scar it's type one and three so the so the the idea was can we make a collagenase that's specific for type one and three so that if we inject it in a penis it doesn't just destroy the skin and everything else around it you want a very targeted enzyme so if you put the thing in your in your science lab into your skin uh to you know for the cheap cheap collagenase you're going to end up with a lot of collateral damage so so this is really an engineered molecule it's a targeted molecule made up of the two most predominant proteins in a collagen plaque and essentially the idea is you put collagenase onto type one and type three collagen it disappears it's gone you can take it a petri dish it's amazing it'll it'll be gone in 45 minutes doesn't work that well in humans for a lot of reasons a lot of reasons we're still studying but at this point after 30 years or so of of research and data and Drug development that's when collagenase for for interlesional therapy in the penis was approved in 2013 in 201 2008 it was approved to dissolve the the collagen based plaque in the hand for the duperrin and that that sort of quick history of collagen uh therapy or collagen a therapy and it uh it really has changed really has changed the entire face of men's health when I trained I trained as mostly as an infertility micro surgery specialist who did some ponies did some erectile dysfunction but mostly you know my future is going to be an infertility and thankfully it still is and I still do a lot of infertility work but over the years I've developed a very robust ponies practice in no small part just because of the research I did that led to the development and FDA approval of this drug it it has truly changed lives of of many many men and it's great I mean it's some men will have you know complete resolution of their Scar and curvature but it is also as I said a few years ago I interviewed in New York Times and probably uh made everybody at at Endo who makes a drug cringe I said it's not a super drug I mean it's still you know not 100% effective it's better than anything we have that was 10 years ago there's nothing even in the pipeline so this is still the only game in town and we're getting much better at injecting it getting much better understanding protocol to even further improve our outcomes and and so again still a huge game changer still an amazing therapy that that doesn't have a huge downside and it's it's still minimally invasive it's non-operative and um and can go back to work the same day so so yeah it's a it has a pretty fantastic safety track record for for improving curvature but if a guy comes in with a 90 Dee curvature and thinks he's going to be perfectly straight with collagenase I tend to disavow him of that and try to set realistic expect expect ation but the majority of men that go through at least in in my practice we have about 80% of men that get one round of eight injections are happy they're satisfied doesn't mean and again this goes back to Patient bother not necessarily angulation and curvature I want to know if you're happy with your treatment and if you're happy with your penis and if your partner's happy to me that's a win and that's a pretty effective medication so how do you set the expectations eight treatments over how long how much modeling are they going to have to do and what is the average expectation first of all it has to be you want to make sure you're going to a place that has a very good team in in place because this is a a big ticket item drug it's not cheap and so authorization is incredibly important most insurance companies carry it but you want to go to a an office that deals with this a lot so that you get authorizations you don't get surprise billing there's also patient assistance for it so so men if they have an out of pocket expense there's a number of patient assistant portals that men can go to to get some of the offset and so that's the first thing I do is expect the set the financial expectations then I say that what's going to happen is you're going to get two injections in a week most of my men come in on Monday and a Thursday and then you're done with me and the 405 and the traffic to get to my office in 6 weeks and then you come back and you get two more injections and so it ends up being a course from the minute I start that injection to the last eighth injection at about a 4 and 1/2 month course it's not all active I mean they're in my office for really minutes of that time we have a pretty good system to make sure we're we're not making people wait too long to do it and in between I have them start modeling right away now again I I have to say some of what I say is is not on label it's really experience I don't inject the way that the label says to inject I and I tell all my patients I'm going to treat you exactly how the the drug was veloped but I have some nuances and modifications that I found have worked better with pretty good clinical data uh how we do it and so one of the things is I have them model pretty much immediately we we set the injection and even that day or the next day I have them stretch for at least 90 seconds a day and then I have them come back in the next uh two to three days we do it again and then yeah I want him to go to town one of the other things that is is critical to bring up and and and again off label considered the hurle for a lot of men is on the label they say well doc I read this and it says I can't have sex for 4 weeks after this and that's a kind of a deal break for that's a long time to say okay you're going to give me an injection and then I wait four weeks so I have basically two weeks of sex before I come back and get whacked again and then get out of commission for four weeks and that was based on some pretty weak data uh that came after label so phase four studies showing that that there was one reported penile fracture with intercourse said about 3 weeks and so out of an abundance of caution which I'm delighted that Endo did uh they said look we want to be sure so we really want people to refrain for four weeks now you're going to get erections during that time period you're going to wake up with erections and you have almost as much risk of fracturing your penis just from an erection at night and you roll over in bed funny than you are with very well lubricated man uh with penis in control of intercourse and so I tend to be a little bit less dogmatic about that and I know most of my my ponies colleagues that do a lot of injections have also gone a little bit away from that because that is sort of uh disruptive and then really no good data that you're doing anything differently and in fact with some of the aggressive modeling protocols that are making the rounds now you're essentially doing way more trauma to the penis and maybe getting a better outcome so in some ways we might be too too gentle you know andx might be a good part of kind of physical rehab that makes sense yeah in a in a responsible you know way yes well lubricated in control there you go I like it and then what degree of curvature reduction can someone expect this is where I hate statistics and quoting because if it if you get a full reduction then I'm the best doctor ever and this is the best drug ever and if you get zero then this drug sucks and you just wasted my money and Time Mill so what the heck yeah and so I we looked I I I tortured a medical student a couple years ago uh he was amazing sadly he went into Opthalmology maybe it was my fault but it was a uh he's a great guy and uh he's going to do well I'm talking about you Rea but he uh I made him do this giant multivariant analysis and look at all of the things that go into our database for how somebody's going to respond presence of diabetes length of blackag degree of curvature all of this stuff to see who's going to be the guy who's going to be that super respon I want to come in with a nomogram I want to be able to examine a penis I want to be able to say you're this and and here are the characteristics your curvature is this way this is what your ult sound showed you're going to be 50% better you're I'm going to take your 50° curve make you 25 every it's going to be great or if I see a guy comes in has a really dense plaque and say you know you're probably going to be closer to 25 really we just don't know who's going to be a great responder and I've been surprised I've been so surprised over the years let me tell you a story of a guy he was very inside uh Healthcare he was a healthcare administrator and he came to me he wanted to be in the phase three study he KN he known about he's read about it he was on all the trades and he said I want to be I want to be in your study Mills Ral me he had a calcified plaque so I did I did an ultrasound I when I do lectures on this I'm sure one of them's online somewhere uh and I I show his ultrasound and and his his X-ray plain fil exra he could e bone in his penis that's how bad the plaque was but he had some collagen around it as well he it was was a heterogeneous plaque so he had some calcium and collagen and I said you're excluded I can't I'm so sorry I can't do this but but calcified plaques are excluded from The Trial so December 13th 2013 that's the day that zlex was approved by the FDA January 3rd he was in my office saying it's time I'm ready we're doing this didn't one surgery he had a 75 degree curvature he got down to 40° with zlex with a calcified plaque he was a guy that you would say no way but he did pretty well so I still inject men that have calcified plaques I just don't inject the calcification part of it so that part of that is really targeting it getting understand either with your tactile feedback or even with ultrasound to know where to avoid you can inject a calcified plaque it's bone you're going to break a needle God forbid inside that plaque so you have to be really careful and and inject the part that's going to win for you and and so even those men have a good recovery I've had other guys had the tiniest plaque I've had guys that have that the plaque is totally gone and they're still curved so again that just goes to show that we just don't know so if somebody is amenable to the time it takes that's the big deal so I say look this you may or may not respond to this you've been dealing with this for one year two years five years and if you want to be better for a cruise in 3 months we're going to go to the operating room and we're just going to fix this for you and here are the risks and benefits of that so that's sort of the expectation I set but the number of men that I've operated on after zlex is pretty small surprisingly small when I see 12200 at least guys a year with ponus disease and I'm still operating I do one or two probably three or four ponus disease surgeries a month uh but I do many many more zlex injections than that so I still think the majority guys do better it just depends on how you define better do you think those people are not getting surgery because they're better or because they just never wanted surgery there's two things I would tell you that to to poke a hole in my statistical analysis one is is right or did they just get frustrated and and were they never surgical canons in the first place that that not too many I mean I you know it's a minimally invasive surgery even at I mean I can do a pation under a local so I don't think it's that and most of the guys that I'm doing zlex on have pretty good erectile function I'm not I'm not doing it on guys that that you know aren't getting good erection so we don't think that's it there are guys that you know may just get frustrated or live so far away from me that it's not worth coming back but no I think most of them are probably getting better we we try to look at that and do some long-term followup and maybe we'll have some publication soon to to show you what that that denominator looks like but um but no I think most of them are are okay with how they're doing and uh and relatively satisfied but again the ones that aren't and and do surgery it doesn't seem to make the the surgery any more difficult and sometimes I think I've I've seen men that would have been a PL excision and graft maybe 75 degrees that I could get away with with appliation and so there there are certain cases where it may help prime or stage them but boy it's a it's a Time commit commitment I mean I can't underestimate that until that these these men are you know 4 and A2 months to get 10° Improvement and then still do surgery that's why you know a lot of times we just go right to surgery yeah it is a time commment is there an improvement after the first injection and like after each injection or do you have to stick it out for the four months yeah there is a again it's a scatter plot there was there was an early early study by by fisel yafi and and Wayne hellstrom I think when he was still his fellow that showed that if if you didn't get much improvement after three rounds or six injections you weren't going to see much on the fourth that caused a lot of people to drop off interestingly enough uh but I haven't seen that and then actually I think in the in the phase four studies a year after therapy people were still getting some improvements and I've I've seen that in in you know about 20% of men that we do a round of zlex on and they're not better and we bring them back I used to just kind of March right along go get the authorization and say come back in six eight weeks and let's just keep doing these for these big plaques but partially again this is an accident of how busy I am that that they can't necessarily come back in in that time and there are men that report that they are actually getting better they're not as bad in fact I not too long ago maybe a week or so ago had a guy great he could have called he lived in the Central Coast right so three four hour drive and and he was there for a second round sat in my office the needle was there he was ready to inject he said yeah I'm better I'm I'm good I just want to make sure we don't need to do this anymore you could could it called you just get eight hours you know so so yeah I mean I think my new protocol is is to give it give it some Breathing Room in that enzyme and just the stretching there's still some plasticity that can last well after that last injection

Dr.

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