Interstitial Cystitis

Today I’d like to talk about something that a lot of my EndoSisters suffer from: Interstitial Cystitis, also known as IC.

Interstitial what? That’s what I thought the first time I heard of it a few years ago.  Heck, my doctor even suspected I had it (we check every time I go in for surgery, and so far: no tell-tale signs).  I’ve been telling myself for a few years now that I needed to research and write about it…so today I am!

What is it?

Let’s start off with:  it’s been around for quite a while.  The first written description of IC was back in 1836 by Philadelphia surgeon, Joseph Parrish.

It is a chronic, often painful,  incurable bladder condition that both men and women can suffer from.  In a nutshell, the signals that are usually sent from the bladder to the brain are a bit mixed up. And this mix-up can cause a whole host of symptoms, which I”ll describe below.   Although incurable…symptoms may regress or completely go away after time.

This condition goes by many names: Interstitial Cystitis (IC), Painful Bladder Syndrome (PBS), Bladder Painful Syndrome (BPS), and oftentimes is just labeled as chronic pelvic pain.

And, like Endometriosis, doctors are unsure as to what causes IC, although they theorize that it may be hereditary, an autoimmune reaction, inflammatory cell growth, an allergy, or a defect in the bladder tissue.

It is unclear how many people suffer from Interstitial Cystitis worldwide, but it is estimated 3-8 million women in the US have it; roughly 12% of women show early symptoms of Interstitial Cystitis; and it’s estimated that of the sufferers of IC, 80% are women.

Symptoms?

Symptoms can vary from person to person, may come and go, may be constant, or may flare-up due to certain triggers.  Some people mistakenly think they simply have a bladder infection.  Common symptoms include:

  • Pelvic pain (it can range from mild to severe)
  • Pain between the vagina and anus (in women) or from the scrotum to the anus (in men)
  • Pain, pressure, or discomfort near the bladder, sometimes relieved after urinating
  • Frequently going pee (some people pee as much as 60 times a day!)
  • Feeling a strong urge to pee
  • Peeing only small amounts
  • Painful sex

Many women report symptoms are worse when they’re on their periods, have a urinary tract infection, after sitting for a long period of time, or even (noooooo!) after having sex.  And the lower quality of life, pain, and other symptoms may also have an effect on emotional well-being.

Types: there’s more than one?!

As of today, there are two types of IC: non-ulcerative and ulcerative. What does that mean?

Non-ulcerative interstitial cystitis is what 90% of IC patients are believed to have.  Little spots or blotches are seen inside the bladder and are called glomerulations.  There’s a caveat (isn’t there always?) – these blotches can be caused by any inflammation, so it’s not a 100% positive diagnostis of IC to just visualize the glomerulations. 

Ulcerative interstitial cystitis is what a lucky 5-10% of IC sufferers have. The red blotches found inside the bladder wall actually bleed.  They’re known as Hunner’s Ulcers.

But wait, there’s more!  A small percentage of IC suffers continue to have symptoms for longer than two years.  Their bladders may be very hard, have a small capacity for holding urine, and are constantly in pain.  This is known as End Stage IC (or Severe IC).  End Stage IC sufferers oftentimes also have Hunner’s Ulcers.

Diagnosis

Just how do you know if you have Interstitial Cystitis? There’s no ONE test to tell you if you do, or don’t have it.

A physician will likely take a detailed medical history, making note of any IC symptoms.  Then steps will be taken to rule out other causes of those symptoms.  A physical examination will likely ensue, and possibly a neurological exam.   And a urine test may be ordered, to also rule out a bladder infection. 

A cystoscopy can be performed, which is when a camera is smooshed up your hoo-haw to look at the condition of the urethras and bladder. The internal examination of the bladder will help look for those blotches we discussed previously.

Another test that may help doctors come to an IC diagnosis is called hydrodistention.  It means they insert a catheter, fill your bladder with water, and measure the pressure as the bladder fills and empties.  It may even give them a first-hand encounter as to your pain responses when the bladder does its fill & pee thing.

Treatment Options

Talk to your doctor before doing ANY of this! I’ve found references to the following treatment options (and this is by no means complete):

Lifestyle changes

Stress may be a big factor in triggering symptoms…so being able to either eliminate or alleviate stress may help ease IC symptoms.

Diet changes

Although there is no official “IC Diet,” many people report that gluten and dairy trigger their symptoms.   A balanced plate of fresh fruits and veggies, grains, and proteins seems to be the overwhelming advice.  Also, avoiding processed foods and keeping a food journal are also popular suggestions.  Many people have found that their symptoms are worse after eating chocolate, tomatoes, spicy foods, carbonated beverages, high-acid food or drink (like cranberry juice), drinking alcohol, or caffeine.  Learn your body and what does, or doesn’t influence your IC symptoms.

Bladder training

literally retraining your bladder; learning to pee on a set schedule, rather than when your bladder screams at you (although, if it is painful…by all means, go!) Bladder training can take anywhere from 2-12 weeks to see results and may help with frequent urination complaints.  Keep a diary of bladder activity to keep track of how you’re doing!

Physical therapy or pelvic floor therapy

A pelvic floor therapist can help stretch and strengthen the muscles of the pelvic floor, which may help with ease symptoms…BUT BEWARE – some studies have shown that it  may also worsen symptoms.  This includes kegel exercises!

MedicATIONs

Over-the-counter pain medications (such as Ibuprofen and aspirin) may alleviate some bladder pain and discomfort.  

A prescription drug known as Elmiron has been shown to relieve IC bladder pain and discomfort.  It was approved by the FDA in 1996.  The manufacturer’s webpage states it is a weak anticoagulant and “[i]t is not known exactly how Elmiron works.”  It may adhere to the mucous lining of the bladder, subduing irritation.  Elmiron also comes with a whole slew of possible side effects that may not be worth it, but decide for yourself and talk to your doctor.

Low-dose tricyclic anti-depressants may relax the bladder, ease pain and improve sleep.  Most commonly prescribed is Amitriptyline.

Antihistamines may also help with inflammation and pain.  If you go this route, though, beware of drowsiness.

There are also several prescription medications used to relax the bladder walls to reduce instances of incontinence.  Think of that “gotta go, gotta go, gotta go right now” jingle on TV.

Gabapentin is an anti-seizure medication and also treats nerve-related pain.  Some studies have shown Gabapentin-use to improve some symptoms in IC sufferers. 

Cyclosporine is an immunosuppressant drug given to patients who receive organ transplants; it’s taken so the new organ doesn’t get rejected by the host body.  A 3-month clinical trial of 26 participants in 2017 found that 30% of them showed improvement in their IC symptoms.  Supposedly, it suppresses immunological responses, aka inflammation, which is an autoimmune response.  Cyclosporine is not yet FDA approved to treat IC.

As always, please talk to your doctor before starting any over-the-counter or prescription regimen.

Distending the bladder

The aforementioned procedure (hydrodistention)  to fill the bladder to test for pressure thresholds, etc. also has been found in some women to relieve their IC symptoms, for a time.

Electrical nerve stimulation

Neuromodulation therapy uses electrical stimulation to alter the way our nerves work.  It’s painless, and sometimes (if the settings are too high) feels like a pinch.

Many people have reported good results with controlling pain using a TENS unit.  

Another option is an implantable device known as the InterSim, which stimulates the sacral nerve to control bladder issues.

Bladder instillation

Going back to the catheter in the bladder method, but this time instead of water or a saline solution, it’s a liquid drug.  The fluid is held in the bladder for up to 20 minutes, then released (aka just let it go…pee it out!). It may cause immediate relief…or a flare-up, but with continued treatments, it may temporarily ease symptoms.

Dimethyl sulfoxide (aka DMSO) is a bladder instillation that is administered weekly, for usually six to eight weeks.    It was approved by the FDA for human use in 2002.  Cystistat and Hyacyst are also bladder instillation drugs, but are not approved for use in the United States.  You can, however, get these treatments in Canada and Europe.

Other bladder instillations may use a combination of different liquid medications and treatments may take place three times a week.

Botox

Just like people get Botox injections to help with facial wrinkles and migraines, you can also get a Botox injection for your bladder!  It’s temporary and may require multiple treatments but may help with overactive bladder muscles.  If you receive Botox injections for your IC, please be sure to tell your doctor if you develop difficulty peeing.

Surgery

In some cases, surgery is the last resort to dealing with pain.   You may be asking how the heck any type of surgery can help with IC issues.  Well…read on:

Under anesthesia, some ulcers inside the bladder may be cauterized.  

A bladder augmentation surgery can make the bladder larger.  

In a cystectomy, they take out your bladder and give you a “new” one using intestinal tissue.  And having this new, non-bladder bladder usually means you’ll need to use a catheter whenever you want to pee.

Other

People have also reported good results with warm baths, stress reduction, exercise, and biofeedback.  It truly is about finding what works best for you and your IC.

If you’re interested in any of these treatment options, please address them with your healthcare provider. 

Know You’re Not Alone

If you suffer from IC, I mean it: you’re not alone. 

The Interstitial Cystitis Association has put together an extensive video library on Youtube with expert interviews, IC advocates, and sufferers.  If you’re curious, you can check it out here

The ICA has also created an online support community for people who suffer from Interstitial Cystitis.  Please feel free to sign up here

The IC Network also has a list of support groups around the United States.  Click here to find one near you!

Just a little note if you’ve made it through my blog entry today and you haveIC…if I’ve misunderstood any of my research or if you would like me to add something, please let me know!

Resources:

Bladder Pain Syndrome (Abstract; Aug. 2017) – Botulinum Toxin in Treatment of Bladder Pain Syndrome/Interstitial Cystitis

Centers for Disease Control & Prevention – What is Interstitial Cystitis?

Cleveland Clinic – Interstitial Cystitis (Painful Bladder Syndrome)

Clinical Trials – Cyclosporine in Interstitial Cystitis: Efficacy, Safety and Mechanism of Action (CIC)

Elmiron manufacturer webpage

Expert Review of Clinical Pharmacology – (Abstract; April 2018) – Pharmacological Management of Interstitial Cystitis/Bladder Pain Syndrome and the Role Cyclosporine and Other Immunomodulating Drugs Play

Harvard Health Publishing – Treating Interstitial Cystitis

Interstitial Cystitis Association – Bladder Retraining

Interstitial Cystitis Association – Interstitial Cystitis and Diet

Interstitial Cystitis Association – IC Plate

Interstitial Cystitis Association – Other Medicines

Interstitial Cystitis Association – What is Interstitial Cystitis?

Mayo Clinic – Overview of Interstitial Cystitis

MedLine Plus – Interstitial Cystitis

National Institute of Diabetes and Digestive and Kidney Diseases – Cystoscopy & Ureteroscopy

National Institute of Diabetes and Digestive and Kidney Diseases – Interstitial Cystitis (Painful Bladder Syndrome)

National Institute of Diabetes and Digestive and Kidney Diseases – Treatment for Interstitial Cystitis

Office on Women’s Health – Bladder Pain

The Journal of Urology – (Abstract; Jan. 2004) – The Historical Origins of Interstitial Cystitis

UpToDate – Patient Education: Treatment of Interstitial Cystitis/Bladder Pain Syndrome(Beyond Basics)

Urology Care Foundation – First Phase: Lifestyle Changes

Urology Care Foundation – Fourth Phase: Cyclosporine

Urology Care Foundation – Interstitial Cystitis

Urology Care Foundation – Third Phase: Neuromodulation, Ulcer Cauterization and Injections

US Food & Drug Administration – Dimethyl Sulfoxide

US Food & Drug Administration – Elmiron

Womens Health Matters – Interstitial Cystitis

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 
Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Endometriosis & the Kidneys

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In the past, I’ve researched how Endometriosis can affect the renal system, specifically the bladder or ureters, and how that could even cause blockages that cause kidney issues and severe problems.

Today, I’m going to talk about Endometriosis and the actual kidney.

A study published in October of 2018 discussed a 45-year-old woman who had flank pain and blood in her urine.  Imaging studies found a mass on her left kidney.  A surgery was performed to remove the suspected renal mass and a portion of her kidney, and pathology confirmed it was an Endometriosis lesion.  It was removed from her “renal parenchyma,” which is the solid part of the kidney that filters blood and makes urine.

My mind was blown!!

That one little abstract led me down a rabbit hole: how many others out there have had Endometriosis lesions on or inside of their kidneys…not just the bits and pieces and tubes leading up to our bean-shaped organs?

But before I get into the studies of women who had Endometriosis growing on (or inside) their kidneys, I want to outline the symptoms of what renal Endometriosis may feel like:

The Symptoms

Here’s a list of symptoms I’ve been able to find that have been associated with renal Endometriosis (you may suffer from some or none of these):

  • Blood in urine
  • Flank pain
  • Renal colic (pain that may feel like you have kidney stones)
  • Lower back pain
  • Symptoms may (or may not) get worse during menstruation
  • Swelling
  • Uretal obstruction
  • Some people had zero symptoms

As always, keep track of all of your symptoms, your pain, any triggers, and the timeline of when these symptoms appear.  It’s very important to walk in with tangible proof of your symptoms.  And, as always, these symptoms may also be signs of sooooo many other things.  It may not be Endometriosis affecting your renal system, but then again…it may.  Don’t discount it.  Please, talk to your doctor.

Published Studies of Endometriosis on the Kidneys

Besides the study referenced above, here are more examples of Endometriosis being found involving kidneys.  I could no locate several studies that were published between 1950-1970, but I still found plenty!

Be advised: renal Endo is considered incredibly rare!  That being said, feel free to print out any examples in the Resources section below if you’re wanting to talk to your doctor about it.  As mentioned in one study, “…endometriosis of kidney is a rare manifestation of a common disease.”  But be aware that it can happen.  Track your symptoms. And always talk to your doctors.

The first known published case of Endometriosis inside the kidney came out in 1943…seventy-five years ago!  Victor Marshall did a lot of research prior to publishing his study and couldn’t find any references to Endo inside the kidney, but did refer to a prior case with an instance of cells that might be Endometriosis on the exterior of the kidney.  But, back to Mr. Marshall’s case at hand:  a 40-year-old woman sought medical care.  Sixteen months prior, she developed a small mass in her upper left torso; six months later, she had complaints of constant swelling and left flank pain.  Sometimes the bump was tender, but her symptoms didn’t increase or decrease around her period.  Two months later, she vomited what she thought was blood.  A few months later, she found herself at Dr. Marshall’s clinic.  The chest and GI x-rays were normal, but the pyelogram (a type of imaging study) showed her left kidney was enlarged, deformed, and functioning less.  She was admitted to the hospital for further care.  The physical exam revealed a round firm mass where she told them it was.  Her lab results, including her urine tests, were all normal.  Surgery was performed.  The mass in the kidney oozed “old bloody fluid,” when it was pierced and they decided to remove her kidney.  Biopsy revealed several cysts inside, one of which oozed 500cc of “dark brown old blood.”  I had to look up how many ounces 500cc was.  Are you ready?  16 ounces!  That’s MORE than a 12-ounce can of soda!  All of the pathologists who reviewed the lesions inside the kidney agreed:  it was “endometrium tissue.”

A 1950 entry in The Journal of Urology is about a 29-year-old woman in 1948 who checked into a local Chicago hospital because of blood in her urine, which had occurred on and off for the past three months.  In 1946, she also had blood in her urine but it lasted for only two weeks.  Her symptoms did not coincide with her period and didn’t seem cyclical in nature.  A physical examination revealed nothing abnormal about her kidneys or abdomen.  Urine tests were positive for red blood cells. An x-ray (excretory urogram) was performed: the left kidney appeared normal, but they had a hard time visualizing the right kidney.  A cystoscopy revealed the bladder was normal.  A pyelogram found the right kidney had abnormalities.  Surgery was performed and  showed several bulging areas which had cysts, one of which was drained of 20cc of “chocolate colored fluid.”  At that point, her entire right kidney was removed.  Pathology confirmed Endometriosis.  Slides of the kidney tissue were also presented at a seminar of pathologists and the group agreed with the renal endometriosis diagnosis.  By 1950, the patient had no recurrence of symptoms.

In 1969, a 43-year old woman was admitted to a Nevada hospital for blood in her urine that had been on and off for the past three months.  She had a history of heavy and painful periods and received a surgically-confirmed Endometriosis diagnosis seven years ago.  A cystoscopy and pyelogram confirmed bloody urine was coming from her right ureter.  A large defect was also visualized on her right kidney (it was a presumed blood clot since it appeared full of blood) and a renal tumor was also observed.  Surgery was performed and they removed her right kidney and most of her right ureter.  Many small cysts were found inside the kidney, and each contained bloody fluid.  The tumor on her kidney was akin to an endometrial polyp.  There was no Endometriosis located within her ureter that was removed.  She continued to treat with her gynecologist for her Endometriosis and was placed on hormone therapy.

A 1976 study was published of a 23-year-old woman who complained of lumbar pain.  Four years earlier, she had a urinary tract infection and two prior kidney infections.   A year before she was admitted into the hospital, she complained of tenderness around her right kidney.  She was treated with antibiotics, but it didn’t diminish her pain. In fact, her lower back pain worsened and became constant.  Imaging studies of her right kidney showed a mass on her kidney.  Surgery was performed.  The 3cm mass was punctured and oozed yellow pus, which later tested positive for E. Coli presence.   While examining her kidney, another mass was found, which was a suspected clear cell carcinoma.  They removed her right kidney.  Pathology found the mass to be Endometriosis.  Since her surgery, she was symptom-free.

In 1980, a 40-year-old woman had a dull, aching pain in the right side of her body, just below her rib cage, for five to six months.  She had no other symptoms.  During a physical examination, a mass was found in her right loin.  An pyelogram was taken and showed excess fluid and loss of function of her right kidney.  Surgery was performed and her kidney was found to be enlarged.  A “glistening membranous” cyst was on her kidney wall.  Surgeons removed her kidney and biopsied the abnormality.  The cyst was filled with a “brownish gelatinous membranous fluid” (sound familiar?) and it was diagnosed that she had an Endometrioma on her kidney.

The British Journal of Obstetrics & Gynaecology published a study in 1991 about a 25-year-old woman.  In 1981, she had blood in her urine, but all tests came back normal.  Over the next three years, the presence of blood was a daily occurrence.  She also developed back pain, which got gradually worse.  Her symptoms were worse after physical activity but didn’t seem to heighten when on her period.  In 1984, imaging studies found a possible tumor on her left kidney.   A puncture test was conducted on the cyst and renal Endometriosis was suspected from the pathology results.  The young woman was referred to a gynecologist.  She underwent a laparotomy and her surgeon discovered an endometrioma on her ovary; it was excised.  No other Endometriosis was located in her pelvis or abdomen.  After surgery, she received birth control pills, which she took for six months and her period stopped.  However, blood persisted in her urine.  Four months after she stopped the birth control pills, her back pain once more became severe and she continued to have blood in her pee.  She had a laparoscopy performed and there were three 1mm endometriomas discovered.  She was given Nafarelin (a GnRH agonist) for the next 11 months.  By the fourth week of treatment, the blood in her urine and her back pain stopped.  Once she stopped the Nafarelin she had another exploratory laparoscopy, in which no Endometriosis was discovered.  But two months later…her urine once more contained blood.  A CT scan showed a new cyst at the site of the original one on her left kidney.  Another puncture test was performed, but the results came back normal.  Three months later, she once more had constant blood in her urine and a recurrence of her low back pain.  She was once more placed on Nafarelin for another eight months.  After the first month of use, she was symptom-free and remained so at the time the study was published.

In 2006, a study was published in Saudi Medical Journal about a 38-year-old gal who had abdominal pain for about two months.  She didn’t have any history of painful periods, urinary symptoms, or irregular periods.  She was described as presenting as “toxic, sick looking” and feverish.    Imaging studies found an ovarian mass and an exploratory laparotomy was performed.  Her right kidney was enlarged and had lesions on it and her right ureter had dilated.  Surgeons removed her inflamed fallopian tubes and both ovaries.  They also took a sample of the kidney lesions.  Pathology confirmed that her ovary and the kidney lesions were Endometriosis.  After the surgery, she responded well to Danazol treatments.

A 2009 report is about a 46-year-old woman who complained of three months of lower back pain.  The pain wasn’t worse on her period.  Physical examination and palpitation revealed a mass in her left upper abdomen.  Urine analysis and blood tests were normal, but an ultrasound and CT scan confirmed a mass on her lower left kidney.  They believed she had a hematoma on her kidney and inserted a catheter (for six days) to drain it.  The mass shrank a bit after the drainage but didn’t disappear.  She had a follow-up visit scheduled for a month later but had to be admitted to the hospital prior to that date because of left thigh pain that caused her issues with walking, nausea, and vomiting.  She underwent a surgery to look at her kidney; the hematoma mass was removed from beneath the surface membrane of the kidney and biopsied.  She received a renal Endometriosis diagnosis; the Endometriosis was lodged beneath the hematoma.  There was no recurrence of symptoms a month after her surgery.

Now hold onto your hats…a 2012 study was about a 13-year-old girl!  This child had blood in her urine and suffered from cramps while peeing, pain in her lower back (more on the right side), and vomiting.  Her symptoms had been on and off for about two years and were worse around her period.  Imaging studies led the doctors to believe she had a kidney stone.  Upon physical examination, her abdomen was somewhat swollen and she had some tenderness near her belly button.  She underwent a barrage of tests and multiple various imaging studies.  The kidney stone diagnosis was replaced with a renal Endometriosis diagnosis.  The clinic did not want to conduct surgery to confirm their suspicions, though (they opine that invasive techniques on teenagers isn’t justified).  She was released and told to seek a surgery consult.  The authors do state, however, that her medical history, symptom history, the fact that it follows her period, and the nodule that showed up her kidney in imaging studies was enough to confirm their suspicions.  (This study was roughly translated from Russian to English and I fear I’ve missed immense details).

In 2013, a woman complained of sudden right flank pain.  She had a history of painful periods and lower back pain.  A mass was felt in the right upper quadrant of her abdomen and a CT scan confirmed the presence of a “huge” renal tumor on her right kidney.  She received two months of conservative treatment, but the tumor did not recede.  Surgery was performed, her kidney was removed, and a biopsy confirmed it was Endometriosis.  Afterward, she was prescribed Danazol and had no recurrence at her 10-month follow-up.  (Sidenote: there’s a photo of the inside of her kidney showing the cysts within…)

Published in 2015 in the International Surgery journal, one study followed a surgery that took place in 2013.  The purpose of this study was to warn others about the misdiagnoses that may occur with renal Endometriosis.  A 37-year-old woman had recurrent dull pain in her right lower back.  The pain worsened during her period for the past six months.  She did not have any blood in her urine or even abdominal pain.  Just back pain.  She also didn’t have a history of painful periods, painful sex, or prior abdominal surgeries. An ultrasound found that she had fluid backed up into her right kidney as well as kidney stones present in the kidney and right ureter.  An x-ray confirmed these findings.  She was given drugs to treat the stones, as well as underwent shock wave therapy.  Neither made her back pain go away.  She was admitted to the hospital in October.  Further x-rays showed the stones were still present, and that her kidney was deformed.  A CT scan showed a mass on the lower right portion of her kidney.  It was thought to have been a tumor.  Surgery was performed to remove her kidney (due to the size of the suspected tumor).  No other lesions or masses were found around her kidney.  When cut, the mass contained “brown, serumlike fluid” within the kidney.  Pathology confirmed that the mass was Endometriosis, and not a tumor after all.

A later 2015 study was about a 53-year-old woman who had gone to the emergency room because of flank pain that she had for several years and she had a mild fever.  An x-ray showed she had stones in both kidneys.  An ultrasonogram also showed that her right kidney was contracted (her kidney appeared scarred and atrophied).  She was admitted for a suspected kidney infection.  A CT scan showed an abscess in her right kidney, too, which invaded into her psoas muscle.  The abscess was drained and three days later her right kidney was removed.  Lesions were found within the kidney and she was diagnosed with renal Endometriosis.   And the patient was symptom-free at her follow-up appointments.

Now what?

This blog entry is not intended to scare you.  It is meant to educate you.  Endometriosis has been documented on and inside the kidneys.

If you fear you may suffer from renal endometriosis, keep track of your symptoms.  That’s crucial.  Bring your diaries and notes and these studies to your physician.  The good news? In all of these studies, a mass was visualized in imaging studies.  And in most cases, a physical mass was felt during a physical examination.

Start there.

Even if you don’t have renal Endometriosis, you really can’t mess around with symptoms of any type of trouble with your kidneys.  Backaches? Abdominal aches?  Blood in your urine?  Run to your doctor…whatever it may be, it’s not normal and may be a sign of something far more detrimental to your health.

Resources:

BMC Research – (Article, Oct. 2015) – Endometriosis in a Kidney with Focal Xanthogranulomatous Pyelonphritis and a Perinephric Abscess

British Journal of Obstetrics & Gynaecology – (Abstract, April 1991) – Renal Endometriosis Treated with Gonadotrophin Releasing Hormone Agonist.  Case Report. (full article may be accessed here)

Child’s Health – (Abstract, 2012) – Renal Endometriosis in a Child (full article may be accessed here…head’s up – it’s in Russian.  I used DocTranslator to read it in English)

Fertility & Sterility – (Abstract, July 2009) – Renal Endometriosis Presenting with a Giant Subscapular Hematoma: Case Report (full article may be accessed here)

Il Giornale di Chirurgia – Journal of Surgery – (Article, Dec. 2017) – Renal Endometriosis Mimicking Complicated Cysts of Kidney: Report of Two Cases

International Surgery – (Article, 2015) – Renal Endometriosis Tends to be Misdiagnosed as Renal Tumor: A Rare Case Report

Journal of Endourology Case Reports – (Abstract, Oct. 2018) – Renal Endometriosis: A Case of an Endometrial Implant Mimicking a Renal Mass (full article may be accessed here)

National Cancer Institute Anatomy of the Kidney & Ureter

Saudi Medical Journal – (Article, 2006) – A Young Woman with Endometriosis of Kidney

Scandinavian Journal of Urology and Nephrology – (Abstract, March 1976) Renal Endometriosis (full may be accessed here)

The Journal of Neurology – (Abstract, March 1980) – Endometrioma of the Kidney: Case Report (full article may be accessed here)

The Journal of Urology – (Partial article, Dec. 1943) – The Occurrence of Endometrial Tissue in the Kidney (full article may be accessed here)

The Journal of Urology – (Partial article, Oct. 1950) – Endometriosis of Kidney (full article may be accessed here)

The Journal of Urology – (Partial article, Sept. 1969) – Renal Endometriosis Associated with Hematuria (full article may be accessed here)

Urological Science – (Article, March 2013) – Renal Endometriosis Mimicking an Angiomyolipoma

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

Endometriosis Caused Leaking Out of a Hole by the Hip?

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What the heck am I talking about?

There’s a study published in August of 2018 that I just read, and it threw me for a loop. So I wanted to share it with you.

A 52-year-old woman went to her Primary Care Physician because she had a weird leaking hole near her right hip.  It just drained a nasty discharge.  He put her on antibiotics for two weeks, but it didn’t resolve.  After suffering from the drainage for two months, she went to the emergency room.  You can see a photograph of her little hip-hole here.

Her prior medical history included a nephrectomy (the removal of one or both kidneys) and a c-section.  She also denied any changes to her bowel habits, any signs of infection, or abnormal weight loss.  She didn’t have any signs of fever, her white blood cell count was normal, her blood circulation was fine, and her abdomen was a little bit tender.

A CT scan found a “cystic lesion” near her lower right pelvic area and a fistula that exited out of her body near her right hip.  Now before I go on, I had to look up what the heck a fistula was.

In my super layman understanding? It’s a hollow tube from one place to another.  In this poor woman’s case? From her bowel to the outside of her body.  The authors classified it as an enterocutaneous fistula…You can only imagine what that discharge must have been. (Ewwww)

Due to the surprising results of the CT scan and a concern for a bowel perforation, she underwent a laparoscopy.   The cystic lesion discovered in the CT scan was “severely adhered” to her pelvic floor and to her bowels where her small intestine and her large intestine meet, aka the terminal ileum.  They removed the mass and the section of intestines in one fell swoop and the biopsy results came back as positive for Endometriosis…so she received a diagnosis of Ileal Endometriosis.  The authors of the study believe that this Endometriosis caused the enterocutaneous fistula…the hole that she had been leaking discharge from her right hip.  She was released from the hospital six days later without further incident.

Not only is this incredibly rare…it’s believed to be the first case of its kind.  So please don’t panic at every oozing sore you may have on your body.  BUT…do arm yourself with the knowledge that it can happen.

I was amazed and flabbergasted by this study.  Of course, the authors don’t opine as to how the ileal endometriosis caused the enterocutaneous fistula, but chalk that up to one of the many mysteries of our illness.

Resources:

Journal of Gastrointestinal Surgery – (Abstract; Aug. 2018) Ileal Endometriosis: a Rare Cause of Enterocutaneous Fistula  – Please contact me if you’d like to read the entire article

Inner BodyTerminal Ileum

UCSF Health – Enterocutaneous Fistula

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

EndoBelly: Before & After Pictures

One of our local San Diego EndoSisters, Michelle, had a flair-up of EndoBelly yesterday afternoon.  If you suffer from these, you know what we’re talking about.  If you’re not sure what it is, I tend to think it’s the disease inside my body inflaming and rearing its ugly head.  The bloat is severe.  The pain is thick.  The skin is stretched to an extreme.  The pants must come unbuttoned.  People would ask “When’s the baby due,” having NO idea I wasn’t pregnant.  When it happens, I must pop a pain pill and find comfort in a bed and a heating pad.  And, for me, it can pass after a few hours or a few days.

But what a difference a day makes.  Michelle granted me permission to share her image here.

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On the left (in the red) is yesterday’s EndoBelly in all it’s swollen glory.  And on the right (in the black)  is today’s deflated and back-to-normal belly.

What a difference a day makes!  And these before & after photographs bring a visible sense to an invisible illness.  Thank you, Michelle, for allowing me to share your photograph.  And your pain.  Love you, woman.

Do you suffer from EndoBelly? Tell us about it in the comments below.  Anything help you cope ’til the swelling subsides? Share away!

Livia: A Device That May Help Period Cramps & Period-Related Lower Back Pain

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Some of you may be asking “What is Livia?”  It’s been hyped in the news and social media since 2016 and has recently made a comeback in my Facebook newsfeed.  Livia recently won the Gold for Women’s Wellbeing at the  Edison Awards.  Imagine a tiny device that you can wear around discreetly all day.  It retails for roughly $150 on MyLivia’s webpage and Amazon and you can purchase additional gel pads to use for future cycles.

Some have compared the Livia to a TENS unit.  TENS units can be large, bulky, cumbersome, and not to mention intimidating with all of the buttons, wires, and knobs.  Sure, I can figure it out…but then I’d also have to lug that thing to work, out shopping, etc.  The Livia is a small, discreet, and incredibly user-friendly medical device.  It supposedly works by tricking the mind by keeping it busy with a little electric pulsing that deflects or confuses the pain signals going up to your brain…I had my doubts.

A study of 163 women who suffered from severely painful periods was conducted, and 80% of them reported that Livia either “helped to either significantly or completely eliminate their use of pain medications while menstruating.”  There was a recent 2018 study conducted on the effectiveness of Livia to treat painful periods, and those results will hopefully be released by the end of the year.

As a side note regarding Endometriosis pain (which, as we know, can be far more severe than normal menstrual cramps), Livia’s manufacturer can’t recommend Livia for use in treating endometriosis until an independent clinical study among endometriosis patients is completed in 2019. However, dozens of endometriosis suffers have posted messages reviews on Amazon and other places saying that Livia is very effective in reducing or eliminating their endometriosis pain.

 

 

 

On June 17, 2018, I wrote Livia to inquire if I could connect with someone at the company to discuss their product and how it has helped women with Endometriosis.  I also asked if they’d be able to provide me customer testimonials by women who suffer from Endometriosis.  I explained who I was and that I suffer from Endometriosis and write a blog about the illness.

A day later, I had a response.  After answering a few questions about my blog and my intentions, Livia offered to mail me a unit in exchange for my unbiased opinion and review.

I jumped at the chance!

It arrived from Israel on June 27, 2018.  I took copious notes and wanted to share my experiences with you!

The Great Unboxing!

 

 

As of the writing of this blog (July 9, 2018), I used the Livia from June 28, 2018 through July 4, 2018.  I expected to start my period the week of June 28, 2018.  I experienced all sorts of cramping and PMS symptoms, but alas, my period never came (sometimes I skip a month).  But, my pain was elevated enough where I believe the Livia got a good test run.  And I look forward to testing it out on future painful days.  I also had another excision surgery on July 18, 2018, so it will be a few months before I will be well enough to test the Livia again.  But test I shall!  Stay tuned!

I also learned that Livia is only intended to be used for menstrual cramps and lower back pain associated with menstrual cramps.  Due to my Endometriosis and resulting scar tissue, I also experience pain on the lower edges of my pelvic region near my hip bones, and along the underside of my ribs.  The Livia is not intended for use in those areas.  In fact, any placement of the Livia gel pads near the thoracic region is strictly forbidden.  And I asked about the use of Livia for neck or shoulder pain: again, please do not use the Livia for any other area of the body except menstrual cramps and menstrual-related lower back pain.

Okay, on with the show!  Here’s a summary of my experiences.  If you’d like to read my detailed notes, please feel free to read them here.

 

 

  • June 28, 2018: It tickles.  But you soon forget about the tickle and pretty much forget you’re wearing it.  For me, my ideal setting was hitting the + Button twice.  So, let’s call it Level Two.  Anything beyond a pleasant tickle is too much, according to the user manual.
  • June 28, 2018: PMS cramping pain was a 4-5 out of 10.  It dropped to a 1 out of 10 just 17 minutes later. Within an hour of turning it on, I had zero PMS cramping.  I turned off the unit, and my pain returned an hour and 15 minutes later.
  • June 28, 2018: PMS cramping pain was a 4 out of 10.  Within 45 minutes (took some time to adjust the settings), the pain had reduced to zero!  Sometimes it crept back up to a one but dropped back down quickly to zero.  Turned off the device an hour after turning it on.
  • June 28, 2018: PMS cramping pain returned within an hour of turning off the Livia.  It was a 4 out of 10, but within 15 minutes of wearing the Livia on Level 2, it had once more reduced my pain to a zero out of 10!!  Turned off the device after an hour of having it on.
  • June 28, 2018: Pain returned within 10 minutes of shutting off the device.  It was now a 5 out of 10.  Turned it back on to Level 2 and within 20 minutes, pain reduced to zero…again!  Kept it on for about an hour.
  • June 28, 2018: My biggest tip to pass on about the Livia?  When you have to use the restroom, instead of unclipping the unit from your pants or dress or shirt, simply turn the device off and unplug the gel pads cable from the unit.  Mind the dangling “tail” as you pee, then reattach it when you’re done.
  • June 29, 2018:  PMS cramping returned at a 5 out of 10 and I reached for my trusty Livia, turning it on to Level 2.  Within 15 minutes, the cramps subsided to a zero out of 10!  It turned off the Livia five minutes later.  While driving, my Livia pad felt a little squiggly on my skin, and I pulled over and looked down.  It had peeled half-way off.  Not off of my skin, but off of the flower pad.  So I peeled it all the way off and stuck it back on, smooshing real hard.  It remained on the rest of the day.
  • July 3, 2018:  I didn’t have any cramps for the past few days, but they came back at a 6 out of 10.  So I turned my Livia on to a Level 2 for 15 minutes and my cramps were reduced to a 1 out of 10.
  • July 4, 2018: Cramping was a 6 out of 10.  I grabbed my Livia, slapped on my pads, and plugged it in, turning it up to Level 2.  I couldn’t feel the usual buzzing-tickle on Level 2, so I bumped it up to Level 3.  About 20 minutes later, my cramps were back down to a wonderful 1 out of 10.

All of the pain I’ve felt since July 4th has been in areas that I was recommended not to use my Livia:  my lower pelvis near my hips, my under-ribs, and a weird spot near a cyst that I know exists.

I never tried the Livia on my lower back since that pain was been super manageable at a 1-2 out of 10.  But, when that pain exceeds a 2 or 3, I’ll be sure to try it out.

I am the most skeptical person you’ll ever meet.  Especially when it comes to products that are marketed specifically for conditions that a large population suffers from: like painful periods.  But this device was truly incredible.  I’m elated.  And flabbergasted.  And amazed.  And excited.

But was it worth it?  Of course, it was for me since I didn’t have to pay.  But would it be worth it for $150?  I’d like to say, “Yes.”  At least for me.  Livia offers a 120 Day Money Back Guarantee, although some online reviews mention that you have to pay a sometimes hefty international shipping charge to send it back to Israel.  And there’s a 2-year warranty on the product when you purchase it, so if it breaks during that time, you’re covered!

It’s small.

It’s adorable.

It’s easy to use.

It recharges on any mini-USB charger.

And, for me, it worked like a charm!

Granted, I couldn’t give it the 100% Endometriosis-period test…but it did help with a lot of my PMS pain and cramping.  And I also will be doing another full review after my surgery if my painful Endometriosis symptoms return.  Again…stay tuned!

Would I recommend it?  I’m gonna have to say Yes…but I will also highly recommend you keep your own notes and evaluate how well it works (or doesn’t) for you.  And take advantage of that money back guarantee if it doesn’t.  There is no shame in returning something.

Resources:

Clinicaltrials.gov The Effectiveness and Safety of LIVIA Transcutaneous Electrical Nerve Stimulation (TENS) in Women Suffering from Primary Dysmenorrhea.

HealthcareDive.com – (Press Release) Livia – Drug Free Solution for Menstrual Pain Now HAS FDA, CE, and Health Canada

MyLivia.com – FAQs on the manufacturer’s page

~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa

Orilissa: AbbVie’s New Drug to Manage Endometriosis Symptoms

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Screenshot of FDA Drug Label for Orilissa, July 24, 2018

You may have seen news articles and press releases flying around the Internet since yesterday regarding a new drug released to manage Endometriosis pain.  I wanted to share this with you because, although I’ve no intention of taking the drug myself, I know that it may help women who suffer. And it may help better educate you on your decision.

I’ve been following it for a while and you can read my thoughts on this blog entry about AbbVie’s SpeakEndo commercials and website, as well as their expedited application for FDA approval, and the track records of other drugs that have done the same.  And according to Business Insider, Orilissa may cost approximately $850 per month, or roughly $10,000 per year for prescriptions (I’m assuming those figures are calculated without health insurance).  Orilissa is estimated to hit markets for prescriptions in August of this year.

So, here you go:

On July 23, 2018, the Food & Drug Administration approved AbbVie’s new drug to treat Endometriosis pain. You may have seen it referred to as Elagolix, but it has been officially named Orilissa. It is an oral GnRH antagonist.

Please do your own thorough research before talking to your physician.

In the Resources section below is a link to the FDA’s drug fact sheet, which includes a .pdf of the pamphlet that should come with the drug. Read it. Review the clinical trials. And decide for yourself.   You can read the .pdf which I have downloaded, or by following the link to the FDA’s site and downloading it for yourself.

It appears it has limited allowable dosing (6 months to 2 years), may cause liver issues, may cause bone loss, may cause depression and suicidal thoughts, and may interact with hormonal birth control. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.

One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.

Where did I get all this info? The FDA drug pamphlet.

Don’t trust me, read it for yourself.

Weigh the pros and cons.

And talk to your doctor.

We are our best advocate. Do what you feel is best for you. But, please, do it informed and do it safely.

Knowing how poorly my body handled Lupron Depot (another AbbVie product that is incredibly similar), and how I became so severely depressed and suicidal on it, I will never again subject my body to something similar.  It did nothing in the long-term to stem my Endometriosis.  And was an incredibly difficult journey while on Lupron, as well as a long while before my body cleared itself of any side effects.  That is why I choose not to take Orilissa.  The decision is an individual one.  Never again.  But, again, I will never tell you not to try something; it may very well help you cope with your symptoms.  Understand, though, that it is a band-aid.  It will mask your symptoms; not clear your body of Endometriosis.  I learned that one the hard way…

If you do your research and make a well-informed decision to start (or not start) Orilissa, I wish you all the best of luck and health.  There are no judgments here.  Only well-wishes.

And, if you wish to see a quick snapshot of the participants and findings of the two clinical trials, please visit this FDA page.

**Updated August 17, 2018**

Resources:

AbbVie – (July 24, 2018; Press Release) AbbVie Receives US FDA Approval of Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis

Business Insider (July 24, 2018; Article) A New Treatment for a Condition that Can Feel Like Tiny People Skating on Razor Blades in Your Stomach and Affects an Estimated 200 Million Women Just Got Approved

US Food & Drug Administration – Drug Database: Orilissa

~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa

Reader’s Choice: Melatonin & Endometriosis

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One of my readers, Erin, emailed me asking if I could look into taking Melatonin for Endometriosis pain and symptoms.  She had heard that it may help reduce the symptoms, pain, and maybe even the lesions themselves.

So, on goes my Research Cap and it begins!

Melatonin is a natural hormone produced by the body as the light fades.  Many people take Melatonin to help them fall asleep and stay asleep.  It’s been coming out in studies over the past decade that Melatonin may play a role in helping reduce Endometriosis lesions and pain.

In 2008, a study was published about 25 rats that were surgically implanted with Endometriosis.  Interesting enough, it found that the rats that were treated with Melatonin were found to have fewer and smaller Endometriosis lesions than rats that received nothing.

In 2010, another rat study took place, this time comparing rats who were given Melatonin to rats who were given Letrozole.  Thirty rats were induced with Endometriosis, given Estrogen for 2 weeks, then surgically confirmed to have Endometriosis lesions present.  Some received Letrozole for 2 weeks.  Others received Melatonin for 2 weeks.  They were all surgically opened up and their Endometriosis lesions were recorded and measured.  The rats received another 2 weeks of Estrogen, then were finally studied.  It found that the rats who received Melatonin had fewer and smaller lesions than the rats that were given Letrozole.

In 2012, Melatonin was referenced in a study about different types of pharmacological treatments of Endometriosis.  It stated that past studied have shown that daily Melatonin usage had reduced the volume and size of lesions and reduced oxidative stress markers.  As far a dosing goes, rats were given 10mg a day for 18-28 days.  It stresses that the doses had not yet been tested on humans.

A Brazilian study published in 2013 found stated that Melatonin was thought to help Endometriosis because it’s an analgesic, antioxidant, and anti-inflammatory.  It studied 40 women over an 8-week period.  Some of them were given a placebo, and the others were given 10mg of Melatonin each day for 8 weeks.  For those who took the Melatonin, 40% of them had reduced daily pain and 38% of them had reduced painful periods.  They also had an improved quality of sleep.

In March 2015, a study was published discusses various doses of Melatonin given to rats that had been implanted with Endometriosis.   Unfortunately, the abstract did not divulge the doses given to each rat and the results.  It did; however, state that Melatonin treatment did result in the regression of lesions in the rats.

I know I’m excited to read about the possible benefits of Melatonin when it comes to Endometriosis.  BUT, there’s always a “but”…

The US Department of Health and Human Services states short-term Melatonin use appears safe; however, little is known about the safety of long-term Melatonin usage since studies of long-term effects have not been conducted.  Also, some people have complained of side effects while taking Melatonin:  dizziness, drowsiness, headache, irritability, nausea, and stomach cramps.  Many users have also complained of grogginess the next day.

Then there’s the question of dosing.  What is the appropriate dose of Melatonin?  A 2001 study identified the proper dose of Melatonin to help people sleep is 0.3mg per day, taken just before bed.  Sleep.org stated a dose between 0.2mg and 5mg taken an hour before bed would be sufficient.  For people who have sleep-wake cycle problems, they’ve taken 2-12mg of Melatonin for 4 weeks.  The study of Endometriosis in women was a 10mg supplement for 8 weeks.

There are also indications that Melatonin may worsen depression, cause high blood pressure (or negate blood pressure medications), worsen bleeding in people with bleeding disorders, may interfere with immunosuppressive therapy (for organ donor patients, etc.), and may increase blood sugar levels of diabetics.

Don’t forget about the “don’t take this medication with this medication” category.  Since Melatonin may be a sedative for many people, avoid taking Melatonin if you take other medications that may cause drowsiness.  Some examples would include Klonopin, Ativan, Donnatal, and Ambien.

There is some concern out that that taking Melatonin may cause hormonal issues.  Since Melatonin is technically a hormone created by the body, supplementing it may cause imbalances or

As always, please talk to your physician before starting any type of new regimen, whether it be pharmaceutical, supplements, diet, or lifestyle changes.   I know I’ll be talking to my physician.  And always understand that little is regulated in the supplements market.  Do you own research and act wisely.

Do you take Melatonin for your Endometriosis? Have you noticed a difference? Please let us know by leaving a comment below!

Resources:

Archives of Gynecology and Obstetrics (March 2015, Abstract) The Effects of Different Doses of Melatonin Treatment on Endometrial Implants in an Oopherectomized Rat Endometriosis Model

Dr. Tori Hudson – (May 2014, Blog) The Effect of Melatonin in the Treatment of Endometriosis

Empowered Sustenance – (June 2014, Blog) Melatonin Isn’t a Sleeping Pill: 3 Reasons to Avoid Melatonin

Fertility & Sterility (April 2008, Article) Regression of Endometrial Explants in a Rat Model of Endometriosis Treated with Melatonin

Fertility & Sterility (April 2010, Article) The Effects of Letrozole and Melatonin on Surgically Induced Endometriosis in a Rat Model: A Preliminary Study

Fertility & Sterility (Sept. 2012, Article) Pharmacologic Therapies in Endometriosis: A Systematic Review

Huffington Post (March 2016, Article) Read This if You Take Melatonin to Sleep at Night

National Center for Complementary and Integrative HealthMelatonin: In Depth

PAIN – (June 2013, Abstract) Efficacy of Melatonin in the Treatment of Endometriosis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial

WebMDMelatonin

~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa

Have you Seen the Endometriosis Commercials on TV?

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Screenshot of SpeakEndo.com; 1/30/18

Updated note (July 25, 2018): Orilissa (Elagolix) was approved by the FDA on July 23, 2018.  You may read more about that, and my thoughts, by following this link.

I don’t have TV, but I’ve had a lot of friends and loved ones excitedly tell me that they saw a commercial about Endometriosis recently! I think that’s awesome! A wonderful way to spread awareness to so many people!

Like one friend said, it took me 20 years for a diagnosis – maybe it wouldn’t have taken so long if I had seen a commercial similar to this one. If it can help just one woman begin to search for answers, it’s awesome.

So, I checked out their webpage, SpeakEndo.com and watched the recent TV ad. If you haven’t seen it, you can watch it here. In late August 2018, a new commercial was released, which you can watch here.  I thought it was wonderful for encouraging women to be open and honest about their pain symptoms. Periods aren’t embarrassing – just tell your doctor so they can make sure everything is okay. They won’t know something is wrong if you don’t speak up! Embrace that personal power and self-advocacy!!

SpeakEndo also creates a community for women to share stories, bond, and learn together. It also provides resources on how to prepare for an appointment with a physician to discuss Endometriosis. And it gets better: for every person who signs up on SpeakEndo, a donation is made to the Endometriosis Foundation of America; although it doesn’t state what that donation amount is.

Then I did some digging. And please understand: this is an expression of my opinion. I developed it based on gut feelings and what little internet information I could find. Purely my opinion. Please feel free to do your own research, digging, and thinking:

AbbVie’s name hovered over the commercial toward the end after they released the webpage information. “Who’s Abbvie”, you ask? A pharmaceutical company. Not just any pharmaceutical company, but the one who manufactures and markets Lupron Depot, a GnRH agonist used aggressively by physicians to treat the symptoms of Endometriosis. I was on Lupron Depot for six months (you can read my experience here) and many other women have suffered from long-term effects of the drug (you can read about their lives after Lupron here). It’s not a drug I will ever take again. I feel like the harsher physical and mental side effects of the drug were not verbally disclosed to me, and it was literally the hardest regimen I’ve ever endured. It’s so much more than “chemical menopause.” If you’re interested in reading up on some of the other side effects that weren’t verbally discussed with me (literally, I was told it was “just like entering menopause”), check out the FDA’s product packet insert here (Pages 10-12 discuss adverse reactions).

AbbVie is also currently working on a new GnRH antagonist called Elagolix to treat Endometriosis and fibroids. It would be in pill form instead of an injection like Lupron. The most common-reported side effects during the clinical trials were hot flash/hot flush, nausea, and headaches. I haven’t been able to find the lesser-reported side effects. But having been on a GnRH agonist for six months and enduring a wide gambit of effects including hot flash, nausea, and headaches; I will never personally take another. I could only hope that Elagolix’s lesser-reported side effects will be equally disclosed and discussed prior to prescription and administration of the drug to patients.  Reported benefits of long-term Elagolix use have been reductions in fatigue, menstrual cramps, non-menstrual pelvic pain, and painful sex.

Am I going to sign up for SpeakEndo.com? Nope. After scrolling to the bottom, seeing AbbVie is the owner of the site, reading their privacy policy and their terms of service, I’ve no desire to embed myself with a pharmaceutical company.

A large part of me can’t help but think that the push for the FDA priority review, the timing of the Endometriosis commercial and the launch of the SpeakEndo webpage are financially motivated and targeting a niche market:

  • 2013-present: AbbVie conducts clinical studies of Elagolix to treat Endometriosis pain and symptoms;
  • May 2017: SpeakEndo.com domain name secured by AbbVie
  • Sept. 2017: AbbVie seeks FDA review and approval of Elagolix;
  • Oct. 2017: FDA approves a priority review of Elagolix;
  • Jan. 2018: SpeakEndo commercials hit TV screens;
  • July 2018: FDA approval Orilissa (Elagolix)
  • SpeakEndo is owned by AbbVie, Inc.;
  • AbbVie manufactures and distributes Lupron Depot and Orilissa, two medications targeted to mask symptoms of Endometriosis;

AbbVie received FDA approval for a priority review of Elagolix, shortening the usual 10-48 month approval process to an expedited 6-month approval process…meaning Elagolix could be approved as early as mid-2018. An article published on January 29, 2018, stated that AbbVie shares were “up over 100 percent over the past year” and a September 25, 2017, article stated that Elagolix was “expected to have an annual cost of therapy over $7,000” in the United States alone.

In the past, the FDA has approved prescription medications on a priority review basis, only later to be withdrawn from the consumer market. Priority review is granted for drugs that “would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions” and drastically shortens the time of approval to push the drug to the consumer market. Following is a list of examples of a few drugs that were approved on a priority basis, only to be withdrawn:

  1. After a 9-month review, Accutane was approved by the FDA on May 7, 1982, to treat acne. Ads were placed in magazines and on TV. During the first six months of its release, physicians had written 200,000 Accutane prescriptions. As time and technology progressed, Hoffman-La Roche (the manufacturer) secured the domain names FaceFacts.com (focused on acne with teenagers) and derm-infonet.com (acne with adults), which have been described as webpages that were non-branded information sites that provided “medical information on the subject of acne and acne treatments.” In 2000, Hoffman-La Roche had raised over $7.5 million from Accutane sales alone. In 2001, the FDA Consumer Magazine said Accutane was “the biggest breakthrough in acne drug treatment over the last 20 years.” Then, in 2009 the manufacturer withdrew it due to an “increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies.” There were years of regulation reviews and hearings, as well as over 7,000 lawsuits filed by consumers.
  2. Abbott Laboratories created Cylert to treat ADHD/ADD targeted mostly at children and teenagers. It was approved under a priority review in 1975. Cylert was advertised in medical journals, such as the American Journal of Psychiatry, touting it’s “once a day convenience” instead of a need for multiple doses.  By December 1998, the FDA reported there had been 12 confirmed cases of liver transplants and/or death caused by the drug. In 2005, a consumer group raised concerns about the safety of Cylert which was followed by Abbott discontinuing its production (supposedly due to a lack of demand and not influenced by the consumer complaints). The FDA officially withdrew its approval as Cylert was proven to cause liver toxicity and the risks involved far outweighed the benefits of the drug.
  3. A few Irritable Bowel Syndrome drugs have been approved by the priority review process.  In February of 2000, Lotronex was approved for the treatment of Irritable Bowel Syndrome in women. Soon after it was available to the public, the FDA began receiving adverse reaction reports, including constipation and ischemic colitis. In some instances, patients required surgery due to bowel complications…or worse…died; there were reports of 45 surgeries and four deaths. Less than ten months after it’s priority review approval, Glaxo Wellcome withdrew Lotronex from the market. However, since it was considered the only drug available to help some people with their IBS symptoms, it was re-approved in 2002 and was placed back on the market with severe restrictions. In July 2002, Zelnorm was manufactured by Novartis for IBS treatment.  It was aggressively promoted with TV and magazine ads. With the launch of Novartis’ “Tummies” TV commercials, they received 390,000 new patient prescriptions, claiming their ads “empowered thousands of women to talk about IBS” to their doctors. It increased their prescription sales by 90%. However, due to an increased risk of heart attack, stroke, and chest pain, it was pulled from the market in 2007. Zelnorm sales profited Novartis an estimated $560 million.
  4. After seeking priority review, Pfizer received FDA approval in 1997 of Rezulin. It was marketed as an antidiabetic and an anti-inflammatory medication. Due to reports of liver failure and 63 confirmed deaths, the drug was removed from the market in 2000. It had earned Pfizer over $2 billion in sales.
  5. In 1999, the FDA approved Merck’s drug, Vioxx, after a six-month priority review period as a drug to aid with pain, menstrual cramps, and osteoarthritis that was supposedly safer than Advil or Aleve. Magazine and TV ads featured athletes Dorothy Hamill and Bruce Jenner. They both made appearances on the Larry King Show to talk about Vioxx, clarifying that they were both paid by Merck. It’s estimated that Vioxx was prescribed to more than 20 million people. However, it was withdrawn from the worldwide market in 2004 after it was found to increase the risk of heart attacks. It’s estimated that nearly 28,000 people suffered heart attacks and/or death due to Vioxx. Merck profited $11 billion during Vioxx’s four-year sale period.

However, on April 10, 2018, AbbVie announced that the FDA required an extended review of Elagolix before it was approved for the public market.  What are they reviewing that hasn’t already been discussed: data regarding liver function test results from the clinical trials needed to be thoroughly reviewed by the FDA.  The FDA approved Orilissa (aka Elagolix) on July 23, 2018.

I’ve no faith in the FDA’s “priority review” process. The FDA does not conduct their own studies; rather, it depends on the studies by the manufacturers and third parties attesting to the safety, risks, and efficacy of the drugs they’re pushing.

Through my research, I’ve also learned that many pharmaceutical companies have hosted patient groups, organizations, and websites which offered an avenue of support to those who suffer from various conditions. Advertising watchdogs refer to this tactic as “Condition and Behavioral Targeted Advertising,” using unbranded sites to reach a target audience with a specific condition. It’s been described as “specialized health portals and networks specifically created to target consumers based on particular conditions or concerns” through “the use of online video and websites to raise the awareness of a particular disease or condition…designed as educational sites, where individuals can share their experiences with various treatments.” The phrase that really makes my Spider Senses tingle: “specifically created to target consumers based on particular conditions or concerns.”

Eisai, Inc., a pharmaceutical company that manufactures an anti-epileptic drug, owns www.livingwithepilepsy.com. The domain was secured in 2005, but the webpage is no longer active. In 2009, Eisai, Inc. started the unbranded site www.livingwithLGS.com, another epilepsy site which includes “treatment options, transitioning a child to adult care, videos, and tools and resources for caregivers, including a customizable Doctor Discussion Guide.” The site is still active today.

Likewise, in 2001 www.parkinsonshealth.com was launched. It was owned and run by Teva Neuroscience, a pharmaceutical company that manufactures drugs used in the treatment of (you guessed it…) Parkinson’s Disease. Teva Neuroscience even produced a brochure, claiming Parkinsonshealth.com and Parkinson’s Support Solutions were “a comprehensive support program designed to provide the financial resources, support, and education patients and caregivers need.” And the only place that Teva Neuroscience was referenced in the entire brochure? The small print at the bottom of the very last page…If the consumer wasn’t looking for it, the brochure would have read as a completely unbiased publication without any fiduciary interest. The webpage is no longer up and running.

And this sounds much like what AbbVie appears to be doing with SpeakEndo.

I’d really, truly like to think that AbbVie is only reaching out to those in need, spreading awareness of an often misunderstood and neglected disease. But my brain keeps circling back to the fear of their motivation. I truly hope their intentions in setting up SpeakEndo.com were not to prey on those who suffer and seek relief from the pain of Endometriosis, nor to gain from the seemingly-perfect timing of the projected approval and launch date of their drug Elagolix.

Regardless, I am still so very pleased that someone (even if they are Big Pharma) are out there raising awareness of Endometriosis and bringing sufferers together. I can’t say this enough: I hope their intentions are pure and their motivation is appropriate.

**Updated September 5, 2018**

Resources:

AbbVie – products list

AbbVie – Elagolix product page

AbbVieAbbVie Receives U.S. FDA Priority Review for Investigational Oral Treatment Elagolix for the Management of Endometriosis with Associated Pain

AbbVie – SpeakEndo.com Privacy Policy (How We Use Your Information section)

AbbVie – SpeakEndo.com Terms of Service

Acne.orgHow Advertised is Accutane?

AdAgeBig Pharma Finally Taking Big Steps to Reach Patients with Digital Media

AdAgeInteractive: Media & Marketing: Drug Companies Boost Online Media Buying: Roche will Spend $1 Million-Plus

Andantestudy – Teva Neuroscience’s brochure: Caring for a loved one with Parkinson’s Disease

AttorneyPagesBayer’s Trasylol: What Really Happened?

Azilect.com

BenzingaAbbVie Shares Double In A Year; Leerink Moves to Sidelines

BonkersInstitute – 1996 Cylert advertisement in the American Journal of Psychiatry

Center for Digital DemocracyDrug Marketing Moves to Digital: How Pharmaceutical Companies Pitch Consumers Online

Cision PR NewswireAbbVie and Neurocrine Biosciences Announce PDUFA Target Date of Q3 2018 for Elagolix in Endometriosis-Associated Pain

Clinical TrialsStudy to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain

Community CatalystZelnorm: A Case Study in Why Drug Advertising is a Bad Idea

DePirro/GarroneZelnorm

Drugs.comElagolix Approval Status

Drug Enforcement AdministrationLevamisol (Ergamisol)

DrugwatchCelebrities Team with Big Pharma to Promote Drugs, Disease Awareness

Eisai Eisai Announces Launch of Antiepileptic Drug Fycompa in U.S.

Fierce PharmaMerck – Vioxx

Formulary JournalPemoline Removed from US Market

Harvard Law SchoolBabies, Blemishes and FDA: A History of Accutane Regulation in the United States

Lawyers and SettlementsNovartis Withdrawing Zelnorm: But at What Cost?

Los Angeles TimesThe Rise and Fall of the Killer Drug Rezulin

MedTVIs Lotronex Back on the Market?

New York TimesUS Lets Drug Tied to Deaths Back on the Market

Obstetrics & GynecologyElagolix Reduces Fatigue in Patients with Moderate-to-Severe Endometriosis Pain

Obstetrics & GynecologyLong-Term Safety and Efficacy of Elagolix Treatment in Women with Endometriosis-Associated Pain

Organic ConsumersBayer: A History of Profit from Suffering

ProCon.org35 FDA-Approved Prescription Drugs Later Pulled from the Market

Regulatory Affairs Professionals SocietyFDA Approves Pfizer’s Mylotarg 7 Years After It Was Pulled from the Market

RochePatient Organisations

Seeking AlphaAbbVie Should Obtain FDA Approval for Elagolix

Strataco

Tradmarkia.comFaceFacts.com Trademark Information

US Food & Drug Administration – Cylert pamphlet

US Food & Drug AdministrationDrug Approval Database – Accutane

US Food & Drug AdministrationDrug Approval Database – Cylert

US Food & Drug AdministrationDrug Approval Database – Lotronex

US Food & Drug AdministrationDrug Approval Database – Mylotarg

US Food & Drug AdministrationDrug Approval Database – Permax

US Food & Drug AdministrationDrug Approval Database – Rezulin

US Food & Drug AdministrationDrug Approval Database – Trasylol

US Food & Drug AdministrationDrug Approval Database – Vioxx

US Food & Drug AdministrationDrug Approval Database – Zelnorm

US Food & Drug AdministrationGastrointestinal Drugs Advisory Committee and Drug Safety and Risk Management Subcommittee Background Package

US Food & Drug AdministrationPriority Review

US Food & Drug AdministrationSequence of Events with Vioxx, Since Opening of IND

US Library of MedicineElagolix: A Promising Oral GnRH Antagonist for Endometriosis-Associated Pain

Whois.com – Domain Name Search – Facefacts.com

Whois.com – Domain Name Search – IWalkBecause.org

Whois.com – Domain Name Search – Livingwithepilepsy.com

Whois.com – Domain Name Search – LivingwithLGS.com

Whois.com – Domain Name Search – Parkinsonshealth.com

Whois.com – Domain Name search – SpeakEndo.com

~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa

Update from earlier this week

Dear Readers,

Well, I’ve popped at least one Naproxen Sodium every day this week.  Today, the pain was so bad I tossed back a Tylenol 3 with Codeine and chased it with a Zofran.  It even hurts to take a deep breath and I feel like my entire torso has swollen up and is tight.

10:30am…popped the pills

4:10pm…the pills are wearing off.  The pain is coming back and the nausea from the Zofran is here full-force…So, I called my doctor for a consult and ultrasound.  I remembered that he was going to be out of the office for a while this & next month, so figured I’d be seen in late September or October…

BUT, his incredible staff made an awesome suggestion: the other healthcare provider who works in his office can get me in TOMORROW at 9am for a consult and ultrasound!!! I adore Mara and trust her nearly as much as I trust Dr. K! This will be our first ultrasound together, and her first hands-on experience with my septated canal and dual cervix! It’ll be a party down below!

So, here we go.

I’ll keep you all updated.

Which also means my “Feel Good Fridays” post for tomorrow will be published later than usual.

Standby…

Love, Me.

PS – I HATE this freakin’ disease!