ARCHIVE: Verapamil - Injections & Topical Applications including Iontophoresis

[zigwyth]

Thought I'd jump back in. My Urologist, explained to me that about 30-40% of his patients had success with TV. He didn't go much into detail other than the successfull patients were able to get an erection without pain and most of the plaque had broken up along with Vit E units. He didn't go into before/after curvature or anything else. I was prescribed TV 15% in Feb. this year and told to apply 4 times a day. Although I have been averaging 3 times a day, I am also trying the infrared therapy (ie. Joshua). I have had the "Hourglass shape" since December 05 after trauma following intercourse. The only thing I have noticed since using the TV is no pain now and firmer erections. Plaque is still there although KIMO has given me some hope. I am considering talking to my Uro again about the Ionto and signing up here at least to gain some knowledge. I will approach him with the fact that living in Austin, Texas with San Antonio, Houston and Dallas just a  couple hours away would probably produce an innumerable amount of potential patients. Knowledge is Power-Zig The Twig out

[Hawk]

I hate to be cynic here, but most patients wouls agree that there are only 2 issues to be considered at bottom line, reduction of deformity, and better erections.  Plaque reduction very often occurs as plaque matures and it can sometimes make things worse.  Also, pain goes away with virtually all patients within the first 12 months or so with absolutely no treatment.  I could tell most patients to draw a smiley face on their penis once a day and their pain would be gone within 1 - 6 months assuming they were already into Peyronies Disease at least 3 months when the came to me.

I am not saying TV does not work, only that in my opinion, reduction of pain should never be considered a sign anything is working in Peyronies Disease unless you can turn the pain on and off by starting and stopping the treatment.  Reduction of pain is the expected norm with Peyronie's Disease.  It is the just the normal progression one expects to see even without treatment.

[Joshua]

Hawk:
I think your post is on the money... I have seen many many studies on Peyronies Disease that seem to always include the relief of pain in the 70-90 percent range. I don't know if I completely agree with you that plaque reduces with age. However, I can't argue the fact that is exactly what happened with my case. so you might be right here as well. The bottom line is we may not even be realising a placebo effect with verapamil treatments but just the natural regression of the disease. This seems to be the problem with the study of Peyronies Disease treatments. They should likely only include curve reducing and erectile improvement.

[Tim468]

Some of the studies. like the one in the archives regarding iontophoresis, demonstrate a *difference* between the study drug/procedure and placebo or alternative drug in effect on pain.

This suggests that pain reduction can be associated with certain interventions. It is a relief to see that most newer studies include measure of erectile function, pain, quality of life and not just curvature.

I am halfway through my first iontophoresis, and so far, no change. One caveat - I seem to be "active" right now and if it is only holding me from getting worse (who could ever know?? - I don't have a "control Tim" to try alternative treatments on). But the published data suggest that someone with longstanding problems like me would be harder to treat. Similarly, thicker plaque, or more established scar might be harder to treat as well. Therefore, I promised myself that I would do three cycles before I said this was of no help.

One other issue with intophoresis: I am using the Physion application cups. The application pads by IOMED are probably better able to be applied in awkward positions than simply the dorsum (I have played around with some samples and the TransQ-E pads seems best). The next go-round, I am going to use the IOMED pads - full report to follow....

Tim

Physion cups and setup:  http://www.physion.com/peyronie_edu/patientfriendly.html

IOMED stuff:  http://www.iomed.com/prod-transqe.html

[ComeBacKid]

I started my first IONO treatment today, and as Tim has pointed out the hardest part is to get the cup on your penis without the liquid leaking out the sides.  Its almost impossible to keep an erection or semi erection, and the cup is just to large for my penis in the flaccid state.  I either need new smaller cups, or Ill have to use tape to somehow seal the edges of the cup. The treatment seems very difficult to administer, even with the help of someone else it wouldn't help me cause the cups are simply to big.

ComeBackid

[ComeBacKid]

I was searching in some other forums about IONO treatment and I came across this post:

Date:   10/21/2005 1:06:22 PM
Name:   Hawkman  
I've now decided to give these machines away free at www.peyroniesforum.net

Is someone inpersonating Hawk?

ComeBackid

[hopeful]

Tim... a few questions.

1. How long have you had Peyronies Disease
2. How Peyronies Disease- what is the curve- degree- etc.
3. How long have you been with IONTo?
4. What Dr. did you go to?
5. Are you using the Physion?
6. The protocol- did your doctor give this to you- or is this your own
I visited Dr. Carroll and walked away with a $1500 bill and no machine- I have the prescription- have done a lot of research and it seems to make sense as it (IONTO) is being used for numerous applications in the medical field.

I am waiting for a company that makes a needlees injector who has contacted AUxillium to see if they can participate in their trials... still waiting to hear something- as I do not believe sticking a needle in the penis is a smart thing to do..

Please let me know..

Hopeful

I thought I'd post here what I sent a member in response to a private email abuot iontophoresis. Hope this helps someone else do it with a minimum of fuss and mess.

Here are some generic thoughts and suggestions:

1) Soak in a hot tub for a while immediately before iontophoresis. There are data to suggest that penetration of medications into the tissue is easier through well-hydrated skin.

2) Set up and prepare your application area first. I do it in bed at night. I pop the tops off of all my vials first, get out the syringe, get organized etc.

3) Do NOT shave the penis/scrotum, pubic region just before application. In order to get good adherence of the sticky pad (and to avoid hair-pulling pain), it makes more sense to shave the area THE DAY BEFORE. This includes the area at the top of the thigh where the grounding pad goes. Make it big enough to allow placement without catching hairs! Shaving at the base of the penis on the dorsum and a bit up onto the lower part of the belly, allows placement of the dispersal unit close to the base of the penis.

4) To draw up any liquid medicine, first draw up that amount of air, and inject it into the bottle, and then start to withdraw the medicine. Thus, the Syringe is filled with air to 4cc, and that is injected into the bottle of verapamil, and this makes it easier to withdraw the solution. Carefully and gradually pull out the needle, as you withdraw medicine, to get it all into the syringe. Hold the vial up to the light to be sure you can see the last bit come out.

5) After getting the larger volume verapamil, redraw about 2 cc of air into the syringe, and inject 1 cc of air into the dexamethasone vial. Them as you did before, withdraw the dexamthasone into the syringe, bringing the total volume there to 5 cc. Re-cap syringe carefully and set aside to use when ready. I gently mix the meds by tipping the syringe back and forth.

6) Place the dispersal unit on the dorsum of the penis (that is the part that faces "up" when you have an erection and it is sticking straight out in front of you!). Thus, the electrode connection on the dispersal unit is facing up. It says that it is easier to do if you first get a partial erection, but it is my experience that it is not too  easy to get or keep an ereciton when you are about to apply electrical current to your penis!!

7) Carefully insert the needle tip into the opening on the dispersal unit. I have found it is MUCH easier to get the fluid in without overflow if you gently lift the unit up and away from the skin of the penis (to which it is adherent). Conversely, if you push downward, it tends to bubble back up and out of the dispersal unit. When there is enough fluid to cover the inner tip of the electrode (just look at the unit when you get it - you will see  what I am talking about), you can cap it off with the connector to the stimulation unit.

The black connector goes to the grounding pad; the red to the penis end/dispersal unit. With the Physion unit you just turn it on. If you have a more fancy one, then what you do is set it to a 4 milliAmp setting and run it for 20 minutes (which is what the Physion unit does automatically).

Finally, in terms of insurance coverage, I did not even try to get it covered, although I might be able to if I really fight for it. But I do have a deductable set-aside from my paycheck called a "FlexFund" and I can get reimbursed (at least) for the costs of out of pocket medical care. Thus, these medical costs are paid by you, but you don't have to pay taxes on the money that you earned and then spent this way.

Tim

[Tim468]

Tim... a few questions.

1. How long have you had Peyronies Disease

30+ years - but it is getting worse lately.

2. How Peyronies Disease- what is the curve- degree- etc.

Dorsum, moderate upward curve, with two new area of induration (dents)

3. How long have you been with IONTo?

Halfway through it - no results yet, but that was sort of expected as my disease is longstanding.

4. What Dr. did you go to?

None - I am an MD - just ordered it for myself.

5. Are you using the Physion?

Yes.

6. The protocol- did your doctor give this to you- or is this your own

These were simply tips I posted to help others with some of the details that are not well explained online or in the directions.

Tim

[Tim468]

I thought I would post some information I obtained from a couple of researchers associated with iontophoresis - names and some parts deleted for privacy. Sort of an FYI to share some of what I have discovered along the way... (emphasis or editorial comments are added in bold font).


********** an email from IOMED *********

Last week while traveling we had promised you a more thorough response to your questions. Below you will find your questions along with responses from one of our scientists. Please let us know if we can be of any additional assistance.

1) do you have any data on standard differences for skin in different anatomic sites (i.e. back, arm, palm) regarding resistance?

Typically, the skin resistance on the palm and sole is significantly higher than on other body sites. The dose controller (Phoresor) provides sufficiently high voltage to deliver the electric current and to compensate for the higher resistance. However, differences in the stratum corneum thickness may reduce drug penetration to these sites as compared to other body sites.

2) do you or anyone else compound medications for delivery via this transdermal route? For instance, Peyronies disease was treated using transdermal delivery of "8 mg dexamethasone and 5 mg verapamil diluted to 5 mL with water."  Or, is this something that a lab (I have a lab) could easily mix up on their own? Could any compounding pharmacy do this?

There are number of papers out of Italy indicating good success rates using iontophoresis of verapamil and/or verapamil in combination with dexamethasone.

Verapamil hydrochloride is a relatively small molecule (FW 491) that is water soluble and positively charged at physiological pH, therefore, it is a good candidate for iontophoretic delivery. The drug should be delivered from the positive (+) (red lead) polarity electrode patch.

There is a commercial injectable formulation of verapamil (Abbot Labs) that contains 2.5 mg/ml verapamil hydrochloride and 8.5 mg/ml sodium chloride. The presence of a relatively large quantity of NaCl is undesirable because small, highly mobile Na+ ions will compete with the drug for delivery. Your lab or any compounding pharmacy can can easily prepare more iontophoretically efficient formulation. We would suggest preparation of a 20 mg/ml aqueous solution of the drug.

Dexamethasone sodium phosphate (disodium) is a relatively small molecule (FW 580) that is water soluble and negatively charged at physiological pH, therefore, it is a good candidate for iontophoretic delivery. The drug should be delivered from the negative (-) (black lead) polarity electrode patch.

There are commercial injectable formulations of 0.4% (4 mg/ml) and 1% (10 mg/ml) Dexamethasone sodium phosphate. Again, your lab or a compounding pharmacy can prepare more iontophoretically efficient formulation, such as 20 mg/ml aqueous solution of the drug. ["aqueous" means "dissolved in  water"]

There is no established protocol for iontophoretic treatment of Peyronie's disease. If you choose to mix verapamil with dexamethasone we would suggest to iontophorese first from the negative (-) polarity (black lead) then switch to the positive (+) polarity (red lead). If you choose to use the mixture, there is no reason to use simple 1:1 verapamil : dexamethasone mixture. More efficient drug delivery can be accomplished however in the two separate sessions by sequential treatment using iontophoretic electrodes hydrated with the single drug formulation.

3) How would drug delivery differ from your gel system compared to a chamber system ["chamber" refers to the Physion style of a cup for the medicine, instead of a gelfoam patch] (see above reference)? Is any difference likely to be reliably similar for different drugs? Or could one predict the difference based on the chemistry of the individual drugs?


There should be no significant difference in drug delivery from IOMED "gel system" as compared to a chamber system. If electrochemistry in the drug delivery electrode is properly controlled, the iontophoretic drug delivery is predominantly governed by the total delivered charge (current in mA x time in minutes = total charge mAïmin), formulation and drug properties.

Thanks again for your inquiry, I hope this helps.

*******************

***************** email exchange from Physion scientists/representatives

"Tim." wrote:

I thought that the verapamil and dexamethasone were premixed together, but it seems they are sent separately. Are they then mixed at the time of delivery (i.e. 2.5 mL of each for a final volume of 5.0 mL)?
 
Tim
******
-----Original Message-----
From: physion.com

The two medications cannot be pre-mixed because together they are stable only for 24 hours.

Physion, Inc.
*********

-----Messaggio originale-----
From: Tim

Thanks for the information...

In reading up on this topic, it seems that verapamil is positively charged at a physiologic pH, and dexamethasone is negatively charged at a physiologic pH, which suggests that verapamil would be best infused from the positive polarity lead (the red lead), and dex infused from the negative polarity lead (the black lead). If the two drugs are mixed, it would seem that it would be OK to simply switch polarity after a period of time sufficient to infuse one, then switch and infuse the other. I do not see this addressed in the literature. Any thoughts on this would be appreciated.

Thanks for all of your help.

**********

Dear Tim,

Thank you for your very correct remark on polarity. The point is that Dexamethasone has indeed a negative charge but only a slightly negative equal to one in a scale of 0 to five. Therefore Verapamil, which has all five positive charges, is the one dragging Dexamethasone. This does not imply a change in polarity, we are normally using positive polarity when administering the mix of Verapamil and dexamethasone, or when we are using lidocaine with deamethasone for different indications.

I trust this explanation fills this conceptual gap properly.

****************
-----Messaggio originale-----
Da: Tim
A: PHYSION
Oggetto: RE: Information Request from www.physion.com


Thanks for the information. It sounds like an electrostatic bond (not covalent) holds verapamil and dex together to allow them to piggyback together into tissue. Are there data to support that this actually works (for example, concentration of verapamil or Dex in solution before and after iontophoresis)?

I like this idea of them going in together - and I had wondered if one had applied a reverse polarity if it might pull the first drug OUT of tissue and back into solution - or is that too silly an idea?

************
From: physion

Once the drug is caught inside tissues and peripheral circulation we think games are over. But your idea, if applicable, would open a new circle of millionaires I dare guess. Or,  with all due respect, one article could be published on The Journal of Improbable Research ( it's only some good humour meant).

Please, have a nice week end

******************************************

Overall, I learned a lot by asking and my hope is to see if I can come up with a way to treat ME that works. Hopefully this can help us develop protocols that we can use - even if our doctors don't really get it themselves.

More on this thought later...

Tim

[phil]

Hopeful,

I have finally started ionto and there seems to be some improvement.  Only a couple of visits so far.  Have to wait to see how it goes.  I am somewhat optimistic.

Phil

[hopeful]

ARe you doing it yourselof.. or going to a doctor?- if doctor???- who???

Hopeful

I have finally started ionto and there seems to be some improvement.  Only a couple of visits so far.  Have to wait to see how it goes.  I am somewhat optimistic.

Phil

[hopeful]

Tim.. good research.. I have done a lot myself.. and I was trying to find out if there were other IONTO systems such as BIOMED that could do the same thing for less money..I am sure the cost for manufacturing this simple device could not be more than $50-$60 if that.. I was just confused with the polarity issue and drug issue.  I saw your responses from Physion.. were you communicating with Willer or Onella?- and did you get a list of the other doctors.. besides doctor Carroll that is using the device?- I would be curious to know.. and which one are you using Physion?? or BIOMED?

Hopeful


I thought I would post some information I obtained from a couple of researchers associated with iontophoresis - names and some parts deleted for privacy. Sort of an FYI to share some of what I have discovered along the way... (emphasis or editorial comments are added in bold font).

[Tim468]

I chose Phsyion - in retrospect the IOMED one might have been a better choice for alterations in current, etc.

I spoke to many folks at the companies - most of the correspondence was from researchers associated with te companies.

One other small factoid: when you do the ointophoresis, drug leaves solution and is driven into the tissue. The VOLUME of the water does not change.

Tim

[dcaptain]

Guys,

I'm sorry for my lack of input into the forum of late.  I previously needed a break from the whole Peyronies Disease issue as it was just weighing on me, and then as soon as I felt okay delving back into it...I got enormously busy with work.  I have answered those of you who wrote me individually about Ionto recently, but Hawk rightly suggested I update the board on my use of it.  Here goes...

A little background:  I have a 10-15 degree "tilt" to the left.  I use the word "tilt" because there isn't really a "bend," just more of a tilt from the base to the left.  Detecting scar tissue has been problematic because I had an ultrasound, but nothing was detected.  However, AFTER the ultrasound, I felt a small bb-sized plaque dead center, as has been described by a number of people here on the board.  Since then, I've also felt a few small scar-like bumps near the base on both sides.  As such, it's somewhat difficult to tell exactly where the "tilt" is coming from.  Since the ultrasound was done prior to this, I haven't actually seen anything telling me exactly where it's coming from (presumably the left near the base, but the center plaque may be contributing).

I got the Ionto device last fall from my doc here in Chicago (you can probably figure out which one).  I learned to use it and used it religiously at first, probably 2-3 times a week.  I noted some "loosening" at first.  By that, I mean that generally the "pull" of the tilt wasn't as strong.  The problem I noted though was that I didn't know which plaque/site to treat, so I basically used the device on different locations every time.  This obviously weakened its effectiveness because each site wasn't getting as consistent a drug delivery if I had done it at the same site every time.  

However, it became somewhat harder and harder to use religiously as it does take a fair amount of time to use.  I tended to spill the device frequenty, and often the liquid would dip below the level of the electrode, causing the thing to turn off, in which case I had to start over.  Long story short, over time I used it less and less.

In total, I have used the Ionto device probably 20-25 times.  Obviously from the above, there are a number of reasons why I think one could say my usage was not as "directed and thorough" as it could have been.  I've considered going back for more Verapamil as I have been close to out of it, but basically have delayed.  I think if I do do this, I'd keep to a more regimented use of the device.

Did Ionto work?  Unfortunately, I don't think I'm qualified to say.  But given the above, I did note some loosening, yes.  It did not decrease my plaque size, and my "tilt" is still there.  It is however somewhat less strong than it was.  If that is due to the Ionto unfortunately I also can't say with absolute certainty - time may have provided the same change; I simply won't ever know.  

I would however like to re-start Ionto, perhaps in a month or two.  If I do I will tell the board.  Again, I'm sorry I've been somewhat out-of-the-loop.  I hope the above somewhat helps people as they consider options.

Best to all you guys!

dcaptain  

[hopeful]

Thanks Tim...

Do you have a contact at BIOMED?- If so can you post or would you prefer to e-mail?

Hopeful

I chose Phsyion - in retrospect the IOMED one might have been a better choice for alterations in current, etc.

I spoke to many folks at the companies - most of the correspondence was from researchers associated with te companies.

One other small factoid: when you do the ointophoresis, drug leaves solution and is driven into the tissue. The VOLUME of the water does not change.

Tim

[hopeful]

Thanks for posting as i am still weighing on IONTO... I am sorry that you were not able to complete your regimen. Also, did your doc put you on the SOMA protocol as well as this was suggested to me by Dr. Carroll???-

Hopeful..

Guys,

I'm sorry for my lack of input into the forum of late.  I previously needed a break from the whole Peyronies Disease issue as it was just weighing on me, and then as soon as I felt okay delving back into it...I got enormously busy with work.  I have answered those of you who wrote me individually about Ionto recently, but Hawk rightly suggested I update the board on my use of it.  Here goes...

[Tim468]

Several responses lumped together.

dcaptain - I am facing much the same problem that you are - what area to treat? I am starting to favor the use of the IOMED instead of the Physion cups, as the cups cannot be placed effectively on the side - they must "face up", or they will leak. Also, the design does not favor treatment of areas underneath compound curves (like on the side at the base). The medicine-holding pads don't leak either.

hopeful - As for contacts at IOMED, I simply wrote to the contact person and asked some scientific related questions. The questions wre bounced to a staff scientist who gave me his best answer (which are posted below). I would always recommend that anyone else do the same. My background might have allowed me to ask "better questions" or ones might have been more interesting to them. YMMV...

I am also thinking about approaching a compounding pharmacy to make an aqueous solution of verapamil at 20 mg per ML to see if that works better, and given alone instead of with decadron (dexamethasone). Since decadron and verapamil have opposite charges, I am still struggling with the concept of verapamil attaching to decadron and the two of them migrating into tissue together.

One way to test this would be to simply do the treatment and to then draw a drug level of the remaining solution. Ideally, it would be devoid of drug (ie all has migrated into the tissue). I wonder what the reality is...


Tim

[j]

What would it take to actually find out how much (if any) verapamil actually gets to the affected tissue, using iontophoresis?  

As someone who works in engineering it often boggles my mind to see how medical problems have to be approached with guesswork when some seemingly straightforward experiments could clear everything up. The iontophoresis companies say, you might try this or that, hard to say, it could work; and as an outsider I'm thinking - why all the mystery? Isn't this a solvable problem?  

Of course I realize that doctors have to work with live human beings and can't experiment at will.  But sometimes it seems like it isn't even considered.  Would it be possible to obtain tiny tissue samples after trying these various iontophoresis configurations, solutions, and parameters?  What about a systemic test for verapamil - i.e.a blood sample?

[Hawk]

I would suspect it would be very easy to apply iontophoresis preop, and take the tissue during surgery as was done  with the topical varapamil study.  I agree with you J.  Any penile surgeon could do it, even a bad one. Again, it seems it would take no approval since they are cutting tissue anyway, so why are we discussing it when it could have been done years ago?

[ComeBacKid]

After talking to Will Sheppard I learned that there are many different types of collagen that can make up the plaque in the penis, they can be mixed or individual.  No one has actually proven verapamil does break down the plaque on a HUMAN.  Perhaps verapamil really doesnt work on humans, and thats why most people experience no gain from the injections.  There is a method in europe where they stick a needle into the penis and make it straighter, they say it works best in calcifed plaques.  Perhaps the very few patients who see any gain from injections are those that have calcified plaques that are hardened, and the needle breask it up, while the needle going into the majority of patients who's plaques are not calcified but still soft get worse when the needle invades through the skin.  Maybe verapamil injections have nothing to do with verapamil itself, but the needle and what kind of plaque you have.  

Any thoughts guys?

The survey to me, shows no reason to even get injections, as most patients stayed the same or worsened, it definately contradicts what Dr. Trussel told me as he claims 50% of patients see improvement after injections, I doubt he will have any data though to back up his claim if I pressed him.


ComeBackid

[Hawk]

check the link https://www.peyroniesforum.net/index.php/topic,119.0.html

[ComeBacKid]

I would suspect it would be very easy to apply iontophoresis preop, and take the tissue during surgery as was done  with the topical varapamil study.  I agree with you J.  Any penile surgeon could do it, even a bad one. Again, it seems it would take no approval since they are cutting tissue anyway, so why are we discussing it when it could have been done years ago?

This point is a very good one, if any urologists really wanted to find out if TV worked or had a chance at working they would of done this.  Seems like they are more concerned about doing surgeries.  

ComeBackid

[hopeful]

Tim.. thanks for the answer.. I would be very interested if you sourced another verapimnil formula. In the meantime, I will contact BIOMED again.. and get the skinny on their unit and the drug...

Keep up the good work..

Tim/DEcaptain--- are either of you usung a VED.. if so are you following the SOMA protocol?

Hopeful!
[

[dcaptain]

Hopeful,

No, I'm not using a VED.  Sorry I can't be helpful there.

dcaptain

[Steve]

I would suspect it would be very easy to apply iontophoresis preop, and take the tissue during surgery as was done  with the topical varapamil study.  I agree with you J.  Any penile surgeon could do it, even a bad one. Again, it seems it would take no approval since they are cutting tissue anyway, so why are we discussing it when it could have been done years ago?

I remember reading something about the effectiveness of Verapamil getting into the tissue using Ionto, and found the following in an article on 'Peyronie Disease' on emedicine:

Martin et al investigated the use of transdermal verapamil without EMDA to see if the substance would be absorbed through the skin. A commercially available preparation of verapamil gel (0.5 mL, 40 mg/mL) was applied to the penises of men scheduled for penile implantation on the night before and the morning of their surgery. The level of verapamil was measured in the urine and the tunica. No adverse effects were noted. Although small levels of verapamil were identified in the urine (signifying a low level of systemic absorption), none was identified in the tunical tissue. These authors concluded that no rationale supports the topical use of verapamil for Peyronies Disease. This finding may not apply to other topical verapamil preparations; however, the authors make a strong case against the use of topically applied verapamil without EMDA.

In 2003, Levine et al reported on the use of EMDA to transport verapamil into the tunica albuginea. This noncontrolled, nonrandomized, single-blinded study used either verapamil at 10 mg alone or verapamil with epinephrine for 20 minutes in men with Peyronies Disease who then immediately underwent plaque excision. The levels of verapamil in the excised tunica were compared with levels in the tunica from men who either had no treatment or who had intralesional injection of verapamil. These authors found detectable levels of verapamil in 10 (71.5%) of 14 men treated with topical verapamil with EMDA. They found EMDA to be a safe technique that is capable of transporting verapamil into the tunica. Epinephrine, which was used to decrease vascular dispersion, did not increase tunical concentrations. This study did not address the question of whether the verapamil helps the Peyronies Disease at these levels.

I also found a reference:

Recently it
was reported that TEA of verapamil into the
tunica albuginea provides measurable drug
levels in plaque tissue [13].
13 Levine LA, Estrada CR, Shou W, Cole A.
Tunica albuginea tissue analysis following
electro-motive drug administration.
J Urol
2002;
167
(Suppl.): 205–6, A828

I've got both documents saved on my computer if anyone would like copies.

Steve

[Steve]

Hawk,

Wow !  I certainly expected to see some more poisitive results from the VI survey!  As you said, it isn't a randomized study of a large number of VI patients, only who are still active in the forum, but still, it's very interesting.  I'm going to take it to my Uro next week and see if he comments on it.

Steve

[Hawk]

Steve,

I think this is the same study I referred to that tested topical verapamil but not iontophoresis.

Would you check that out and if that is the case let us know.

[flexor]

An aspect of the TV discussion bothers me, and that is the lack of precision in what  is being talked about.

Topical application of medicine is as old as the hills: there's nothing patentable about it. Thus if you asked a pharmacist to make up a topical verapamil, he would supply verapamil in a neutral base, which you would apply as a topical ointment. The problem is that there is no reason to believe that verapamil will travel inwards any further than the surface of the skin.

The other is a transdermal verapamil, where the verapamil is mixed in a transdermal carrier, which carries it through the skin and into the plaque.

PDLabs has a patent on a transdermal verapamil, but as I read the patent it claims protection for verapamil in a specific carrier. Thus it might be possible to have a different transdermal verapamil in a different transdermal carrier not patented by PDL (eg V + DMSO ?). PDL has produced evidence that their transdermal verapamil works: there is no evidence that plain ordinary topical verapamil would work.

PDL has helped cause the confusion, because their patent starts by claiming rights in a transdermal verapamil, but as you read through the patent, this later gets described as 'topical verapamil'. Then later there is a public letter claiming that PDL owns the rights to 'topical verapamil', and threatens action against anyone sle supplying it. In fact they own the rights to a particular transdermal verapamil. The plus for PDL is that verapamil is a potentially dangerous drug in the bloodstream - it reduces blood pressure. The research that PDL quotes shows that their transdermal verapamil is relatively safe: If you mixed up your own transdermal verapamil, or a pharmacist mixed it for you, you don't know if it would go as far as the plaque, or overshoot into the blood stream and with what consequences.

So these two verapamils cause confusion. I have seen a poster say there is no need to go to PDL because his pharmacist will make up a 'topical verapamil' for a lot less. But is it transdermal, or just topical? Similarly people have reported getting a prescription from their uro for topical verapamil. Did he mean transdermal verapamil ? And is that what was prescribed?

Similarly, when Martin and Levine, as Steve's post below, can find no signs of it in excised tissue after applying 'topical verapamil', was it topical or transdermal?

So when we have posts referring to TV or topical verapamil, are we referring to transdermal verapamil (which might work) or plain topical verapamil (which probably wont).? If it came from PDL or Talon, it is probably transdermal, if it came from somewhere else it probably is not: I can't see a reputable pharmacist copying the PDL patent - the profit would not even pay for the cost of replying to the PDL lawyer - but he might put verapamil in a different transdermal carrier, if he recognised the difference between topical and transdermal.

So when posters say that TV did not work for them, depending on what they used, that result might not be surprising.

It would be interesting to know from the members of this forum who have reported disappointing results with TV, if they know whether they were using a transdermal or a topical verapamil.

[Tim468]

I know of no data to support the notion that PDL has a special proprietary formula that promotes movement of verapamil into tissue. They simply have a patent on the very idea itself, it seems. This unfortunately stifles research int the truthfulness of their claims.

Tim

[ComeBacKid]

Ok its been about 3 and 1/2 weeks now, still no visible results from religiously applying Topical Verapamil. Tim is right their patent prevents any pharmacist from creating a "topical verapamil," and experimenting with application agents in the gel because anyone who does this is then threatened with a civil suit for even attempting to make anything.  My old pharmacist who made me verapamil for $99 experimented with different application gels, he also said after calling other pharmacists he knew what PDL's formula was and that in reality, they were charging way to much for their product, he said to make what they make costs only about $45, which means off of each tube, they make $210.  Assuming they keep patients on the medicine for 3 months this results in $630 profit.  

ComeBackid

[ComeBacKid]

For anyone trying IONO get the IOMED pads, they are like a bandaid with a middle party that you can drop the liquid medicine into and then wrap it around your penis like a bandaid, it works a lot better than the cups that come with the PHYSION system,  I was on the phone today with the PHYSION people and told them about it, the guy said at the convention or meeting in two weeks they are bringing over some engineers to create better pads similar to IOMED.  The treatment today was my first and caused me no pain, but a very light shock(more of a slight burning, like when you put on aftershave) but it is nothing to worry about, and it comes on the pad on your thigh no your penis so that is good.  I'll keep everyone posted on any results I see.

ComeBackid

[j]

Here's a link to Easterling's patent application. It's a long link and if it doesn't work, just search for US Patent 6353028.

http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=6353028.PN.&OS=PN/6353028&RS=PN/6353028

The patent application apparently gives all the details of what's in PDL's product and how to combine them. I don't have the technical knowledge to say whether there's anything unique or original in this formula. I don't see any reference to research done by Easterling.  Although Easterling claims that his formula "has repeatably effected, in many cases, a complete reversal of perceptible Peyronie's disease symptoms, and in all cases, a substantial reduction of such symptoms",  no evidence is offered. Apparently that's not required for a patent application.

The application makes the standard claims to a "novel and unobvious" idea but it's not clear to me what that is. I don't think Easterling discovered, on his own, that calcium channel blockers stimulate collagenase production. He seems to have learned about that and had the thought that some fibrotic conditions might respond to a topical or transdermal application of verapamil, then gotten a patent on that idea.

[dcaptain]

ComeBackid,

Do you have a link to these IOMED pads?  Also, would they work with the Physion system?

Thanks in advance!
dcaptain

[ComeBacKid]

Dcaptain,

http://www.iomed.com/

I don't see why not, Tim is also using them with his PHYSION system, the current doesnt change, and if you try IONO you want the POSITIVE polarity, red clip on penis patch, black clip on thigh. I guess I'm going to find out if this works or not over the next couple of weeks.

ComeBackid

[Topanga]

I am new to this forum and thought I would "check in".  I am 57. I developed Peyronies Disease over the last year.  After a little research, I sought our Dr. Rajfer at UCLA -- he offered me the option of trying 6 bi-weekly VI treatments while taking 10 mg of Cialis, 1200 mg of Pentoxifylline and 1 g of L-Arginine daily.  His assessment was that 30% of his patients experienced improvement from this treatment.  I elected to try the VI treatments, which I just completed.  Unfortunately, I experience no noticeable benefit.  I asked him about surgery.  He explained the following to me: in 90% of surgical cases, the penis can be straightened, but that 30% of patients complain that their penises are shortened, 30% experience a change in sensation, and 30% experience some form of ED.

I discovered this forum while searching the web for alternatives to surgery before deciding to undertake the expense and risk involved.  It would appear that in my circumstances, the cost of the surgery would be in the neighborhood of $3,000 out of my pocket, and the risks give me pause.  On the other hand, even though I am divorced and not currently in a relationship, I have the desire to do whatever I can to lean into life and deal with this as effectively as I can, rather than surrender to my condition.  Any thoughts or suggestions are welcomed.

[SteveW]

Welcome Topanga,
You aren't alone.  Many if not most of us have experienced or are going through all of the same as yourself.  Questioning.  Research.  Emotions.  What does make it better, or at least easier to deal with is the fact that we aren't alone.  Contribute often.  It benefits us all.
SteveW.

[ofsho]

welcome topanga
Iam a newbie too. And less qualified than the other members to suggest anything. But I do feel surgery and even drugs should not be an option untill 'the first do no harm approach' is given a chance. I feel a disturbing percentage of doctors fail to recognize, the difference. I've  read good posts about Alc,ionto,arginine,and topical verapamil worked for kimo.And vitamin E along with other supplements that work for what is probaly an autoimmune angle,like VitaminD,coq10,omega three- fatsoluble free radical scavengers and good fats.
I have a bit of a complex situation I've a problem with kidney stones,besides Peyronies Disease
both mild cases (and a vitamin D deficiency, would like some clarity on this ) Iam told vitamin D is good for Peyronies Disease and prostate, but aggravates kidney stones - Iam sorry that my posts tend not to fit into the topic,they keep overlapping!  

[Tim468]

Welcome Topanga,

First off, it sounds like you have a urologist who is willing to give multiple treatments that might work, and is not rushing to sell you on surgery - both good things. I too would caution against surgery too early in the course of Peyronies Disease, and it is arguable that one year in is too soon for that. Also, if you can still physically have intercourse, I would hold off on a surgery. I figure a bent erection and a normal orgasm are better than a straighter erection and no sensation (or even no erection)!

Some might argue that more L-carnitine would be appropriate (ie 2-3 gm per day). This is simply one of many areas in Peyronies Disease care where no one seems to really know what is "best". Hang in there and thanks for posting!

Tim

[Hawk]

Attached are some very interesting results from our monitored member ILV survey.  While the numbers are small, the survey was protected from false entries and reflects accurate information within its limitations.

While this may not surprise some, it makes an impact when you see it in print from our members.i

A big thanks to all that participated.  I have now made the survey public on our website.  If you took the survey once, please don't take it again.






Just click on the attachment to enlarge the resusts of the ILV Survey  

[Hawk]

Judging from the updated survey results in the previous post, either our members are the most unlucky Peyronies Disease patients around or ILV leaves a lot to be desired.

I think I would have to conclude that either ILV does nothing outside of the statistical range of natural progression, or that it improves some but makes a greater number of men worse off.  

keep in mind that maybe only the disgruntled took the survey, or maybe men that greatly improved are gone from Peyronie's Disease forums.  As a personal opinion, I find both of these explainations very unlikely.  I never heard of any member that ever said they saw a single post suggesting, "ILV completely fixed my penis!  I am out of here!"

[SteveW]

I guess I am one of the fortunate ones.  VI certainly didn't hurt (other than the pain of a needle jammed into little Steve every other week for almost 4 months) me; but other than maybe a 10% improvement in my "bend"...nothing was accomplished.  BUT, if research and case studies indicated that 142 further injections would cure me, would I do it?  Yes.  

[Steve]

Amen to that SteveW--if another 150 shots would do the trick, I'd be right behind you to sign up!  I just finished my 12 shots with the only result being a nasty bruise (again).  I'm now trying the VED route as my Uro says the next step is surgery--I'm definately not ready for that step yet!

Steve

[Hawk]

I guess I am one of the fortunate ones... but other than maybe a 10% improvement in my "bend"...nothing was accomplished.  

Well Steve, if we split hairs, as far as our member survey is concerned, you were one of the fortunate one    s  

This of course raises the question of whether the you improved because of the Verapamil or in spite of it.

[SteveW]

This of course raises the question of whether the you improved because of the Verapamil or in spite of it.

Don't I wish I could answer that question.  But, I do know that since halting injections there has been no further improvement.  Or worsening, thankfully.  

However...I am having twinges (aching?) of pain again when erect, which are worse some times than others.  

Crap.

[Tim468]

I am wrapping up a series of iontophoretic applications of verapamil, and thought I would give an update. I am a personally perfect example of why anecdotal medicine is so limited in helping us forge an understanding of physiology - and yet we naturally try to figure out what happens to us, and why. So far, theresults are disappointing.

I used the Physion "Mini-Physionizer", which applies a 4 mAmp current for 20 minutes, with a "ramp-up" to full power over the first minute or so. I used their cup system that is designed to hold 5 mL, although it is impossible to get 5 mL into it, as the level of the injection port determines the "high water mark" for what is injected into the cup (see the company's illustration -somewhat helpful). At any rate, I used their suggested strength of 10 mg Verapamil in 4 mL (2.5 mg/mL strength) mixed with  8 mg of dexamethasone (AKA Decadron) in 1 ml, for a total volume of 5 mL. Again, I usually got about 3.5 mL into the cup, so the total available dose of verapamil was about 6-7 mg. (http://www.physion.com/peyronie_edu/images/Step-4.jpg).

I applied the treatments three times a week, although I fell to about 5 times every two weeks for the last 2 weeks. The results are disappointing; I see no change in anything, although I feel that the fibrotic cord that runs along the dorsum of my penis is "softer". This is a very subjective finding, though. Also, the problem that prompted me to kick into higher gear was the appearance a few months ago of a 1 X 1 cm "dent" at the left base of my penis that causes a leftward lean, and the treatment did not really sit over that portion of my penis. It thus felt as if I was treating the "wrong" area. Moreover, about 3 weeks ago, I suffered a trauma of sorts during intercourse, with an acute bend to my penis when it "caught" as I pulled out and went back into my partner, and it bent acutely dorsally right below the head. That area *hurt* and subsequently has become slightly bent also. I applied the remaining treatments I had to that area, as best I could (although its lateral placement also made use of the Physion cups awkward).

So, some thoughts. First, I had to keep telling myself that longstanding lesions are known to be harder to "fix", and the literature supports that; men with recent onset were and are easier to fix than those with longstanding disease. So the fibrotic cord along the dorsum of my penis - there for over 30 years - should be hard to get rid of!

Second, I believe, but cannot prove it, that the treatments actually arrested the development of a new area of pathology where the trauma was. Of course, without a couple of dozen of me, it's hard to do a real randomized experiment! But the new problem stopped progressing when I started treatments. There is no way of knowing what would have happened without treatments, though.

My plan now is to try the following. I am going to use the more flexible IOMED dispersal patches, and am going to try to see if there is a little bit of reverse engineering that might make "homemade" application patches more affordable. Secondly, I am going to use a 20 mg/mL solution of verapamil that I had a compounding pharmacy make for me (100  mL for $18!). It's pH will be 5.7 (should not be irritating to the skin), and I will be able to put a dose of about 40 mg in 2 mL onto a smaller patch, that can be placed right over the area of concern. I will use the Mini-Physionizer to deliver the drug, but for good measure I am going to see if the output is what it claims to be (shouldn't be too hard to do in my workshop)  Finally, I am going to measure the pre and post iontophoresis drug levels in the fluid to see how much is left over - that seems it would be a good measure of how much went into the tissue.

I will of course keep everyone posted as to results.

Tim

[j]

After about 5 years of reading everything I can find about Peyronies Disease on the net, and digesting every posted experience - oh and did I mention dropping a couple thousand on transdermal verapamil - my totally unscientific, highly emotionally biased conclusion is this: I don't believe that verapamil, in any form, has any effect at all.  The small number of positive reports includes nothing but spontaneous remissions, mis-diagnoses, placebo effect and poor measurements.

I think that IF we saw some convincing study data - actual lab work - showing a real effect in the tissue of actual Peyronies Disease patients, THEN it would make sense to spend more time, energy and money in developing various ways to deliver the drug.  

But it seems to me that the supposed positive effect of verapamil in actual human tissue has been largely inferred from a bunch of poorly constructed studies on patients, rather that being proven up front by solid lab work.  

And of course, I'd be very happy to be proven wrong.

[ComeBacKid]

Tim,

Way to go to bat for us sufferers, it will be interesting to see what you measure after the treatments, this way we can tell if the drug actually makes it in.  

ComeBackid

[phil]

Tim,

Are you going to use dexamethasone also?  And will you connect positive or negative to the active pad/cup?  Did you try reversing the polarity in you earlier ionto treatment?

[ComeBacKid]

Phil,

Tim is using the PHYSION protocol of verapamil and dexamethasome, he also uses the positive charge as what I'm using to drive in the medicine, which is red cable on penis, and black on the thigh.  

Its good we have an MD like Tim who can do these tests and get more information for all of us.

Phil how is your IONO treatment coming along or did you stop for awhile?

ComeBackid

[kevin]

Regarding J's comment about Verapamil being overestimated:

In the November 2003 edition of "Ask The Doctors" page (at the PeyroniesAssociation.org), Dr. Levine writes:

"...The Physion Company of Italy now has FDA approval in the U.S.A. for their iontophoresis (EWDA) delivery system for verapamil. About 50% of my patients have demonstrated improvement when using verapamil solution or even saline alone. Prior research has suggested that electric current may in fact activate the healing process, which may explain why some men with saline respond to this treatment.  Further research is ongoing regarding this phenomenon. ..."

So Verapamil has at times been no more effective than a salt solution, and even those benefits may have been due more to some aspect of the procedure than the substance used.