Genital neuropathy Testing Possibility - Project from Dr Healy

Science
#1

Hi guys,

Bit of an unconventional one, but we’re writing to make you aware of the potential for a UK based test. Dr Healy wants to proceed with a test for genital neuropathy in a small group of PFS, PSSD and PRSD (Accutane) patients.

Professor Healy has reached out as he has had difficulty obtaining a necessary adapter from the company, and as such he is asking for interested patients to email the company requesting that this is provided owing to the importance of investigation into the condition(s). Details of this are below.

As some of you are aware PFS patients with penile sensitivity loss, pain and/or atrophy have been assessed for nerve fiber density and structure, with no difference to matched controls on multiple-site biopsy of dermal prepuce in the past. However, there is some rationale for the possibility of small fiber involvement as a potential outcome and a cross-group finding would always be welcome in the effort to get these conditions under one roof. The benefit of this is that, should the adapter be provided, this would not cost anyone anything and is a non-invasive procedure to be carried out in Sheffield, UK. To be clear, this isn’t via the Foundation and is not diverting research funding, which we know is a concern. As such there’s nothing to lose.

If after reading you are interested in supporting Dr Healy’s efforts by emailing them, please make us aware that you have done so as Dr Healy would like to keep track of how many letters the company is getting. Additionally, please feel free to state your interest in attending. There is a target of 6 per group.

Thanks and best regards,

PH

Hereafter follows part of a mailout from Professor Healy:

Several months ago, we became aware of a device called Sudoscan made by Impeto Medical. It’s mainly used to assess peripheral neuropathy in the hands and feet. The company also have a special adaptor for Sudoscan that can test genital function, but it’s custom-made and isn’t commercially available.

We are interested in Sudoscan and particularly the genital adaptor because we think it has a chance of showing an abnormality in PSSD that might allow people prove their condition exists – it has done so in the case of some diabetes patients – and might get research on a cure going.

One of the UK’s leading experts in peripheral neuropathy already uses Sudoscan and has agreed to help us test PSSD, PFS and PRSD patients if Impeto Medical can supply us the special adaptors. Unfortunately, they seem unwilling to do this and have stopped responding to our messages.

We need your help. We would like you to add your name, city, country, and the date to Letter 1 and email it to jean-henri.calvet@impeto-medical.com.

If possible, we would also like you to get others involved. We’ve included an example letter that can be adjusted (Letter 2) for friends or family. If you come up with any good ideas on ways to drown this company in letters – go for it

CLICK HERE for a letter template provided by Dr Healy

City
Country

MM DD 2019

Jean-Henri Calvet

Impeto Medical SAS
17, rue campagne Première
75014 Paris, France.

jean-henri.calvet@impeto-medical.com

Dear Monsieur Calvet

I am one of several thousand people who have a range of enduring sexual dysfunctions stemming from antidepressants, isotretinoin, finasteride and possibly other treatments. I know there are others with my problem or a similar condition from at least 40 countries including France.

For nearly 30 years the number of us with these problems has been growing. We have been ignored or ridiculed by doctors and others we have sought help from. Many have already committed suicide or contacted assisted dying programs.

Having a test that confirmed the reality of our condition would make a big difference to the way others treat us. It might also trigger the kind of research needed to find an answer to what has happened to us and how to remedy it. Knowing this research was happening would save lives.

I understand your company can supply a device that can be attached to a machine you already market, a Sudoscan, that stands some chance of demonstrating the reality of the condition I have and in so doing might improve the care I get and my prospects of a cure. But I also understand you are not willing to make this available.

I would ask you to reconsider this position. I would imagine if you did, in addition to saving lives, you would likely get more Sudoscan sales. You might be interested to know that the European Medicines Agency has just announced that information about persistent sexual dysfunction after discontinuation of treatment is to be added to all SSRIs and SNRIs products.

I write in hope of a positive response, even though it appears from your lack of response to Dr Healy that you are not willing to engage with us.

Please note that this letter is confidential. My name and contact details are not to be publicly disclosed under any circumstances.

Yours sincerely

NAME

11 Likes
#2

I have e-mailed him.

1 Like
#3

Emailed Jean-Henri Calvet. UK-based too so could potentially participate in the study! Can PM me here on that. PFS patient.

2 Likes
#4

Has anyone received a reply from the Sudoscan manufacturer in regards to this matter?

#5

I haven’t

1 Like
#6

I will email them after work and also let you guys know when I do so. Wouldn’t mind taking a little trip to the UK.

1 Like
#9

He has answered the e-mail. Here’s his reply:

Thank you for your heartfelt letter.

As a medical doctor with strong moral values, ​​I fully understand and share in the suffering that you or your loved ones feel. I also admire Professor Healy’s fight for the recognition of post-SSRI sexual dysfunction as a legitimate pathology.

We are a small French company that has developed a technology to evaluate the function of small nerve fibers of the autonomic nervous system which control the sweat glands. The measurements are taken on the palms of the hands and soles of the feet, the two areas of the body with the highest density of sweat glands. This method has been validated and is now widely recognized, as evidenced by the numerous international scientific publications devoted to it (> 150). Because of its simplicity, it is increasingly being used by specialists in the field of neurology.

Some time ago, a physician who has used the technology extensively, asked us to adapt the methodology to evaluate small nerve fiber function for erectile dysfunction. His aim was to complete a very preliminary study purely in a research context, looking to eventually replace the current standard of care diagnostic test (sympathetic skin response - SSR) which he considers to have limited performance. He wrote a first publication of 25 patients with diabetes who were suffering from erectile dysfunction. Prof. Healy came across this publication, and in the interest of providing optimal care to his patients, requested that we make the technology available for your benefit; this, of course, is a completely scientific and professional intention. However, the adaptation of our technology for this research study does not have the CE marking yet, and therefore cannot at this time be used on a larger clinical scale. We are currently working on filing for the application’s CE marking. In the meantime, your attending physician may use SSR for diagnostic purposes, being cognizant of its limitations. As a physician, as previously stated, I am aware of the struggles with your condition, and do not want under any circumstances to prevent you from benefitting from the latest medical technologies, as Professor Healy seems to imply; this would hardly be ethical. However, we must allow time for adequate research to be completed in order to achieve results that are reliable and usable by all.

Thank you for trusting me in working to help improve your care.

Sincerely yours.

Jean-Henri Calvet, MD, PhD

4 Likes
#10

I have sent the email and can participate in the study

#11
1 Like
#12

PSSD sufferers - please give a like and make a comment on the YouTube video of our brave veteran sufferer Kevin (its unviewable on this forum, so please click the option “Watch this video on YouTube”). Although we suffer from many complications, the focus of this video is on sexaual aspect on which the device from Impeto can help with diagnostics. I think PFS and PAS sufferers comments should be beneficial as well, because our conditions are very close (not only) in this aspect. Thanks a lot!

1 Like
#13

I can almost say with 100 percent certainty that any small fiber neuropathy isn’t limited to erectile function, it just happens to be what’s noticed most.

I’ve had problems with abnormal sweating (or lack of) since Accutane, especially in my face. I also have tested positive for a immune antibody recognized in cases of autonomic nervous system dysfunction.

I would say if anyone has the chance to get this test done even if its just the hands and feet (but clinically validated) it wouldnt be a bad idea at all. I’ll see if they offer anything around me.

#14

Making the Invisible Visible
The problem for SFPN sufferers – and ME/CFS and FM – has been that the diseases are invisible. There’s no way to tell from the outside that the small nerve fibers in your skin or elsewhere have been damaged or destroyed.

If you have SFPN, you’ll probably complain of a range of unconnected, seemingly vague symptoms. Small nerve fiber problems can be driving you nuts – causing you to experience weird sensations, numbness, pain, problems standing, racing heart, gut issues – while you will look fine. When your strength and reflex and other tests turn out normal, your doctor will probably think you are nuts and act accordingly.

The reason these small nerve fibers could be causing so much havoc is that they do so much. Dr. Oaklander lead off her 2015 Immunotherapy paper by calling attention to just how strange the small, unmyelinated C and thinly myelinated D nerve fibers she’s studying are. These primitive nerve fibers engage in an astonishing array of activities. Not only do they transmit pain and sensory signals, they also release substances that trigger edema, vasodilation, modulate immune responses (including mast cell activity), and affect autonomic nervous system functioning. In turn, they are also affected by the immune system.

When small nerve fibers are damaged, you have small fiber polyneuropathy (SFPN). In contrast to the small nerve neuropathy found in the skin, SFPN affects peripheral nerves across the body, causing potentially a staggering array of symptoms from pain to tachycardia, orthostatic intolerance (problems standing), headache, exercise intolerance (due to circulatory insufficiency), gut issues, cognitive problems and more.

A Diagnosis Waiting to Happen?

“The difference between FMS and SFPN labels is not merely semantic – SFPN is an established disease with considerable information established about pathogenesis whereas FMS is an aggregate of symptoms without prior evidence of a biological basis. Oaklander, et al .

Many doctors are aware of small nerve fiber neuropathy – it’s common in diabetes, chemotherapy and infections and exposure to toxins can cause it as well – but my guess is that few are aware of SFPN. It’s not as if they haven’t been unwittingly exposed to it: idiopathic SFN, which is often likely to be SFPN, is not uncommon; fully 30-50% of small nerve fiber problems arise without an understood cause.

The patients who get it, many of whom are women, are often greeted with a psychiatric diagnosis, blank looks by doctors or rounds of opioids which probably won’t block the pain for long, or if they do, will likely have no effect on the actual problem.

After being disbelieved for years or even decades, many patients, Dr. Oaklander said, “break and cry with relief at having something real to finally point to.”

“It’s pretty routine that I have patients who break down and cry when they get an answer for the first time to something that’s been disabling them for years or decades.”

Dr. Oaklander doesn’t know how many people have SFPN but she knows it’s not a small number; if it’s not hundreds of millions of people, it’s going to be at least tens of millions. She’s sure that it commonly occurs in diseases like fibromyalgia, chronic fatigue syndrome (ME/CFS) and irritable bowel syndrome (IBS).

“This is not just some rare, esoteric disease that Harvard eggheads are investigating. It is common. People—including kids and teens—are sick, but they don’t know what they have and their doctors don’t know, either.” Anne Oaklander

SFPN is usually diagnosed via a small skin biopsy – a truly objective test – that many doctors probably don’t know about. Other tests can pick it up – a corneal microscopy test can, for instance, non-invasively and quickly determine if issues with the small nerve fibers in the eye exist. The Sudoscan sweat gland test , questionnaires and others may be helpful as well.

The field is new enough that the diagnostic protocols for some of these tests are being forged as we speak. Dr. Oaklander is assessing the efficacy of all of these tests in a large 5-year, NIH funded study.

Treatment
Oaklander has been thinking about treating these small nerve fiber problems for quite some time. In her 2015 paper “ Immunotherapy Prospects for Painful Small-fiber Sensory Neuropathies and Ganglionopathies ,” she proposed that the vast interplay between the small nerve fibers and the immune system suggest that immunotherapies will probably work better than opioid drugs.

Because SFPN is very underdiagnosed, it’s hardly ever treated properly. That’s a big mistake, Dr. Oaklander thinks: her latest study suggests that a treatment is available that may help many. Dr. Oaklander put her intuition to the test in a retrospective study that examined the medical records of 55 patients treated at Massachusetts General Hospital (MGH) for autoimmune small-fiber polyneuropathy (SFPN).

The study – which news reports back in November referred to but which has not apparently been published yet – found that treatment with intravenous immunoglobulin (IVIG; 2 grams/kilogram every four weeks) provided symptom relief and improved nerve function for 75% of patients.

Dr. Oaklander called the results “wildly surprising” and “paradigm-changing” in that the study presented the first strong evidence that SFPN is an autoimmune condition.

“This is a proof-of-concept finding that dampening the body’s immune system may be safe and effective for treating apparently autoimmune SFPN, a condition that most patients don’t even know they have.”

The really exciting news is that IVIG may be able, in some patients, to actually restore the nerves to normal functioning. Sixteen percent of her patients were able to wean themselves off the drug without their symptoms returning.

“This is the first treatment that has the potential to actually improve the nerve damage , not just block symptoms with drugs such as opioids that don’t address its cause.” Dr. Anne Oaklander

2 Likes
#15

Wow that is very promising sounding

#16

Please help out our longterm PSSD sufferer Kevin by like but most of all by leaving a comment on YouTube under his video, please help him this way with pushing his message regarding this topic

(click “Watch this video on YouTube”)

Many THANKS!

2 Likes
#17

“Penile SFN was ruled out in multiple site biopsy of a number of pfs patients with pain and atrophy”

So why would you even need this experimental non-accredited test? I would think a localized penile skin biopsy would supersede this test as more of a gold standard.
Thats not to say SFPN isnt occuring that might have more of a downstream proximal effect.

I contacted this company, the rep was out of the office but will get back to me monday on nearest locations for this test. Im not far from a few major cities, so hopefully there will be some options.
If a person has a chance to get the basic form of this test, I would start with that.

Again, it could be a start. This needs to be ruled out.

Autonomic neuropathy-in its many guises-as the initial manifestation of the antiphospholipid syndrome.

All patients had persistent antiphospholipid antibody positivity and all patients who underwent skin biopsy were found to have reduced sweat gland nerve fiber density suggestive of an autonomic neuropathy.

Reversible drug-induced antiphospholipid syndrome.

1 Like
#18

Well, my reason why I posted this to be honest is that I simply wanted to help Kevin out - he is around publicly from the very beginning of PSSD, I was not very looking into science details of this test. Anyway, thanks for Your feedback

1 Like
#19

Valid question. Our view is that this is of limited practical value for these reasons. Biopsy is an increasingly gold standard measure and the device in question is esoteric and not widely appreciated. Even if there was a uniform finding, which is highly unlikely given the existing evidence, I think the strange situation trying to get hold of one shows this isn’t likely to be something scientists will put much credence in. There is also already existing objective evidence of pudendal neuropathy correlated with erectile dysfunction in severely sexually dysfunctional PFS patients.

We are contacted by medical professionals we are networked with sometimes, and it was requested this was shared. As it is of no cost and of potential interest, and there’s rationale to believe some pfs patients will have short fibre involvement based on existing evidence, this was posted to make users aware the opportunity is there. We weren’t implying we feel this is a priority.

2 Likes
#20

What the Sudoscan was actually designed for,
“SUDOSCAN is a test that provides an accurate evaluation of sweat gland function.”
Seems pretty well documented and accredited for.

“The test focuses on small nerve fibers that innervate the sweat glands. The degeneration of small nerve fibers reduces sweat gland innervation and impairs sudomotor function.”

^This can be one of the first signs or earliest detection of SFPN ( small-fiber polyneuropathy)

I believe this thought could still make the Sudoscan test very much worthy to at least investigate.
It would also be much cheaper and simplistic over any type of skin biopsy.
As far as availability and how widely accepted its use is in the medical field, I guess I’ll find out Monday.

1 Like
#21

Just figured Id update this. I traded a few emails with one of Sudoscans reps in California. I told him why I was interested in this test, not mentioning Accutane or anything about PFS. To make a short story shorter, I asked for a couple neurologists that were using this equipment near me that id follow up with.
In the entire city of Chicago and even Milwaukee, all he could give me was a foot dr. currently using Sudoscan. He offered for me to call him, but that might be it for now.
So its use seems to be very niche atm.

#22

I did the Quantative Sensory Testing (QST) through Dr. Goldstein. There is nerve damage in the genital region. What to do about it is a different story.

1 Like