Winter 2003

• International News: Japan - International IC Congress, New national group begins in Denmark, ACI Mexico launches all spanish web site on IC, Update from ISSVSH Conference in Vancouver, Update from International Urology Association Conference in Stockholm, Upcoming International Conferences
• ICN Research & Clinical Trial Center: ICOS begins new Phase II trial of RTX, Report from Tony Buffington on NIH study to study role of stress in women with IC & IBS, NIDDK announces $5,000,000 RFA for IC research
• IC Newsroom: An Indepth Look at the new SSA Ruling for IC - Should make disability applications & approvals for IC much easier, Interstitial Cystitis May Cause Many Cases of Pelvic Pain, Repeated UTI Patients May Be Misdiagnosed IC patients
  
• ICN Library Update: Recent Journal Articles on IC
• ICN Guest Lectures: The Truth About Clorpactin - An Interview with Alfred Globus, D.Sc., CEO of United-Guardian, Inc
• Consumer/Safety Alert: FDA issues alert about diathermy with any implanted electrode, How to spot quacks on the internet, Update on colloidal silver & Is sugar a treatment for IC?
• Featured Writers & Columnists: Fresh Tastes by Beverly Laumann on "Holiday Flares, Nutrition and Tricyclic Antidepressants" IC Lifestyles by Gaye & Andrew Sandler on "The Princess & The Pea, Part Two "
• Self Help Tip of the Month - Understanding Pudendal Nerve Entrapment
• ICN Special Project: 2003 IC Survival Guide Library Campaign
• IC Support Opportunities: New Chat & Support Meeting Schedule, New USA Support Groups
• New IC Resources in the ICN Shop
  

JAPAN - International Consultation on IC - March 28-30, 2003
The International Consultation on Interstitial Cystitis Japan will form the first important step towards the development of new diagnostic criteria and a redefinition of interstitial cystitis. Twenty five international IC physicians/researchers and a similar number of eminent Japanese urologists have been invited to Kyoto for an international brainstorming meeting in March 2003. Their goals include the following: (1) to assess worldwide opinions on what is IC and how it is currently defined and diagnosed in different countries; (2) to determine what studies are necessary worldwide to arrive at a consensus definition of IC that will have maximum clinical utility and serve as a guideline for international pharmaceutical regulatory agencies; (3) to assess what information is currently available and what studies are needed to arrive at a unified diagnostic protocol for the practising physician to diagnose IC. Read more

DENMARK - The first meeting of the new national IC organization in Denmark was held on Nov. 7, 2002. Thirty eight patients, spouses and supporters attended to hear Professor Nordling open the meeting and speak on IC and its current treatments in Denmark. Kirsten Bouchelouche gave a presentation on her research work with the drug Singulair for the treatment of IC and her successes to date in treating patients. Anthony Walker, CEO of the UKICSG, was also invited to speak! Read more

ASOCIACION DE CISTITIS INTERSTITICIAL MEXICO
Founded by Florentina Ferreyra López, IC patients in Mexico and Central America now have a new education and support resource. The Asociación de Cistitis Intersticial México was launched on November 6th, 2002. Their new web site (http://www.bcomx.com/aci-mexico) is the first all spanish web site on interstitial cystitis. The ICN has provided permission for the translation of various portions of our educational materials to be included on their web site. Both the ICN and the IICPN are delighted to provide support and encouragement to this new, desperately needed group. Mexico and Central America present unique cultural challenges. As Florentina offered "Women rarely talk about their bladder symptoms with family or their doctors. We have much work to do to reach out to those patients and to educate our doctors." Mexico and Central America present unique cultural challenges. Florentina is an IC patient herself. She is dedicated, energetic and passionate about her new group. Mayra Zamora Toscano provides public relations and translation assistance. We would like to welcome both to the international IC community!

Report from ISSWSH 2002, Vancouver BC
Jill Osborne, MA provides a report from Vancouver BC, where she presented the results of an IC research study on female sexuality. She also reviews several new research studies offering promising results for new therapies for IC and/or vulvodynia, including quercetin, physical therapy, nitroglycerine cream & alpha interferon. Read her report today.

26th CONGRESS OF THE INTERNATIONAL UROLOGY ASSOCIATION
Stockholm, Sweden September 2002 - Julia Godoy, representing the Norwegian IC National Group, attended the 26th Congression of the IUA and reports that IC was not discussed, though Lower Urinary Tract Syndrome (LUTS) was a hot topic. Read her report!

UPCOMING INTERNATIONAL CONFERENCES & EVENTS

March 12 - 15, 2003
XVIIIth Congress of the European Association of Urology (Madrid, Spain)
http://www.uroweb.nl/

March 29-30, 2003
International Conference on Interstitial Cystitis - Japan
http://www.interstitial-cystitis.org/japan1202.html

April 26 – May 1, 2003
American Urological Association Annual Meeting (Chicago, IL)
www.auanet.org

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ICOS begins Phase II Trial of RTX Topical Solution
A new trial for RTX will begin in early 2003. RTX is a small molecule that can be delivered to the bladder to desensitize specific nerves called afferent neurons. Afferent neurons are believed to play a role in many pathological conditions of the bladder and urinary tract such as interstitial cystitis, a debilitating condition often associated with severe pain as well as urgency and high frequency of urination. Dr. Robert Moldwin (and others) is participating. The latest info can be found under our "New York" listing.

Tony Buffington Discusses the NIH Grant to Study the Role of Stress in IC and IBS in women
The ICN is pleased to share a letter & report from Dr. Tony Buffington, Ohio State University. A long time advocate for IC patients, and a lecturer in the ICN Guest Lecture series, he is participating in a new National Center for Neurovisceral Science & Women's Health Treatments, where studies into the role of brain, stress and emotions in IBS, IC and related disorders. Because there has been some concern voiced that this implies that IC is "caused" by stress, Dr. Buffington is responding to those concerns with a detailed and, as usual, extremely compassionate statement to ease your concerns. Read the complete report today

NIDDK dedicates $5,000,000 to fund new IC research studies
In late November, the NIDDK released a new Request for Applications (RFA) "Basic Research in Interstitial Cystitis" that will expand the study of interstitial cystitis into new and under explored areas. Roughly 20 to 25 grants will be funded, totalling $5,000,000. Individual research teams may receive up to $250,000 per year.
Unlike other studies which have focused on therapies and epidemiology, this RFA seeks to attract new investigators with different specialties to join the IC research movement and to apply their specific knowledge of inflammation, epithelial biology, cellular biology, molecular genetics, the physiology of pain, genomics and autoimmunity to the IC cause. It is hoped that the research produced will assist in the development of new diagnostic methods for IC and tools to predict the onset of IC, such as blood and urine tests. Ultimately, this will also provide valuable information that can be applied to new therapies and prevention strategies.

One area that some may find ethically challenging, yet others consider vital for research studies, is the development of animal models for the study of IC. Countless studies have discussed how the bladder reacts to injury. Sadly, this usually involved introducing an irritant into the bladder of an animal. There is significant concern among the medical community that this does not provide an accurate model of a human disease. I'm very pleased to see that this RFA is choosing a different route. Rather than focusing on using irritants, they hope to identify animal models based upon a genetic predisposition.

Let's take a closer look at what they hope to accomplish.

1. The etiology (cause) and pathogenesis (development) of IC is considered a vital area of exploration. Some of the funded research may also include the development of related disorders to IC, such as prostatitis, pelvic pain syndrome, IBSs, Crohns Disease, vulvodyniaa, etc.
2. Disease markers from the urine and biopsy samples of IC remains a strong emphasis, with the hope that these can be used to develop new specific tests to diagnose IC or identify patients at risk of IC.
   
3. Neurological studies are vitally important. Bladder neurophysiology is extremely complex. In the IC patient, they hope to better understand the pelvic pain pathways, and how it contributes to the more severe symptoms of IC.
   
4. The genetics of IC continues to be a priority. Previous studies have demonstrated a possible genetic cause for IC susceptibility. This RFA specifically encourages the study of twins.
   
5. Diagnostic imaging has not been particularly effective in the diagnosis of IC. This RFA encourages the development of new diagnostic and imaging techniques that will visualize and diagnose a bladder affected with IC.

Researchers who hope to participate must provide their letters of intent to the NIDDK by January 21, 2003. Read more!

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SSA Announces New Ruling for Interstitial Cystitis
An Indepth Analysis of SSR 02-2p

IC patients around the USA were delighted to hear that the Social Security Administration has issued a new "Policy Interpretation Ruling" for Interstitial Cystitis (SSR 02-2p), effective November 5, 2002. This should ease the way for patients who are applying for federal disability benefits. Let's take a closer look at the SSA, this specific ruling and how it relates to IC patients.

What's the difference between SSA & SSI?
In August 1935, President Franklin D. Roosevelt signed the Social Security Act to create a social insurance program designed to pay retired workers age 65 or older a continuing income after retirement. To qualify for benefits, a worker must "pay" into the SSA system a modest amount with each paycheck, which then makes them eligible to receive benefits at the time of retirement. In the 1950's, the SS Act was amended to provide benefits to disabled workers who were no longer able to work. It's important to know that Social Security benefits were never intended to be the only source of income when you retire or become disabled, or your family's only income if you die. It is intended to supplement other income you have from pension plans, savings, investments, etc.

The Social Security Administration also administers the Supplemental Security Income (SSI) Program. Rather than being paid by the Social Security trust fund, the SSI makes monthly payments to people who have a low income and few assets. To get SSI, you must be 65 or older or be disabled. Generally, people who get SSI also qualify for Medicaid, food stamps and other assistance. SSI benefits are not paid from Social Security trust funds and are not based on past earnings. Instead, SSI benefits are financed by general tax revenues and assure a minimum monthly income for elderly and disabled persons.

Both SSA and SSI can provide benefits for the disabled. If you have worked for roughly ten years (or less if you are younger), you are likely entitled to apply for SSA benefits. If you do not have a work history and are low income, you can apply for SSI benefits.

Interstitial Cystitis
Some IC patients have qualified to receive either SSA or SSI benefits in cases where they are very seriously ill. Others, however, have struggled to be approved for benefits, in part because SSA has not included IC on their formal list of disabilities. Social Security Ruling SSR 02-2p "Evaluation of Interstitial Cystitis" will dramatically help IC patients during the review process because it clearly states that interstitial cystitis can be a disability and provides guidelines for SSA staff in reviewing IC related applications. This became effective on November 5, 2002.

In reviewing the ruling, I'm very impressed with their description of IC diagnosis, symptoms and therapies. This will serve patients well because it provides a solid education for SSA personnel. For example, they describe IC as "a complex, chronic bladder disorder characterized by urinary frequency, urinary urgency, and pelvic pain. IC occurs most frequently in women (about 10 times more often than in men), and sometimes prior to age 18."

It firmly demonstrates the role of related conditions and how they can contribute to an overall disability. "IC may be associated with other disorders, such as fibromyalgia, chronic fatigue syndrome, allergies, irritable bowel syndrome, inflammatory bowel disease, endometriosis, and vulvodynia (vulvar/vaginal pain). IC also may be associated with systemic lupus erythematosus."

The ruling also describes the individual nature of IC and the pain that some patients struggle with.

"Symptoms of IC vary both in kind and in intensity from individual to individual, and even in the same individual. The three most common symptoms are an urgent need to urinate (urgency), a frequent need to urinate (frequency), and pain in the bladder and surrounding pelvic region. These symptoms may occur either singly or in combination. The pain may range from mild discomfort to extreme distress. The intensity of the pain may increase as the bladder fills, and decrease as it empties. In addition, many patients experience vaginal, testicular or penile pain, or low back and thigh pain."

Given the current controversies regarding the diagnosis of IC (and the diminishing role of hydrodistention), the ruling provides the following criteria for a diagnosis of IC. Please note that it says "some" or "all" of these symptoms, reflecting yet again that IC is so very individual.

A diagnosis of IC is based on the presence of some or all of the following:

• Presence of urinary urgency or frequency (day and/or night), either singly or in combination;
  
• Pain in the bladder and surrounding pelvic region;
  
• Suprapubic tenderness on physical examination;
  
• Glomerulations (pinpoint bleeding caused by recurrent irritation) on the bladder wall after hydrodistention on cystoscopy;
  
• Hunner's ulcers on the bladder wall after hydrodistention on cystoscopy; and,
  
• Absence of other disorders that could cause the symptoms.
  

One controversial question in the IC community can be put to rest, perhaps forever. Should a patient, without Hunner's Ulcers or glomerulations, be diagnosed with IC? We've certainly known that some patients will have a "normal" looking bladder during hydrodistention yet still experience symptoms. This was acknowledged by those who developed the NIDDK criteria for IC. It is comforting to see that SSA will NOT exclude these patients either. The ruling says "an absence of glomerulations or Hunner's Ulcers on cystoscopy does not exclude a diagnosis of IC: a minority of individuals (10%) with IC will not have either of these medical signs."

As much as we'd like to be able to walk in and say that we have "IC," SSA will not approve benefits based upon a statement of symptoms. You cannot just say that you have IC and expect to be approved. You must also have medical evidence (symptoms, signs and/or laboratory evidence) supporting your claim.

The SSA Sequential Evaluation Process
SSA staff will conduct a three stage review of your application:

1. Is your impairment severe?
2. Does your impairment meet or equal the requirements of a listed impairment?
3. Does IC prevent you from doing regular and consistent work?

Obviously, #1 is based upon an examination of your medical history. #2 compares IC to other diseases that have been certified as disabling by the SSA. The ruling is perhaps the most helpful in #3 because it covers the many ways that IC can disrupt our lives and work schedules:

"IC can cause a limitation of function. The functions likely to be limited depend on many factors, including urinary frequency and pain. An individual may have limitations in… sitting, standing, walking, lifting, carrying, pushing and pulling…The effects of IC may not be obvious. For example, many people with IC have chronic pelvic pain, which can affect their ability to focus and sustain attention on the task at hand. Nocturia (nighttime urinary frequency) may disrupt sleeping patterns…. The presence of urinary frequency alone can necessitate trips to the bathroom as often as every ten minutes, day and night. Consequently, some individuals with IC may confine themselves to their homes."

Conclusion
While it would have been most helpful if SSA had classified IC as one of their listed impairments, this ruling is certainly beneficial. It will provide sound, factual information for SSA personnel to better understand IC and why patients may apply for disability. We can't promise 100% approvals, but let's hope that it speeds up the process and reduces the rate of first time denials. Congratulations to all who have written the SSA, their Senators and Congressmen asking for compassion for IC patients. Your words were heard. It took many years to accomplish this change thanks, in great part, to the efforts of the ICA-US as well.

Additional Reading & References:
Text of SSA Ruling
ICA Press Release: Nov. 5th, 2002
Understanding Social Security
A Brief History of Social Security

Interstitial Cystitis May Cause Many Cases of Pelvic Pain

The November issue of the American Journal of OB-GYN presented the results of Dr. Lowell Parsons study of women with pelvic pain, suggesting that the frequency of IC in the US may be 20 times greater than previously suspected. "IC is a clinical syndrome of urinary urgency/frequency and/or pelvic pain. Its presence traditionally has been difficult to detect, due to the intermittent and progressive nature of the symptoms and because the disease is so easily mistaken for other urologic and gynecological disorders." Four US medical centers participated in the study and administered the KCL test to 244 consecutive patients with pelvic pain. 84% reported urological symptoms. KCL was positive for 197 patients (81%) and none of the controls. "IC may be a common unrecognized cause of pelvic pain and deserves greater consideration in the diagnosis of pelvic pain." Dr. Parsons discussed this study in depth in the ICN Guest Lecture Series. Read that transcript here! AM J Obstet Gynecol. 2002;187:1395-1400

Repeated UTI Patients May Be Misdiagnosed IC patients

Research presented at the 23rd Annual meeting of the American Urogynecologic Society (AUGS) suggests that women who phone in reports of repteated UTI's may be experiencing IC flares instead. Dr. Edward Stanford (Centralia IL) presented the results of a study administered to 106 women. The KCL test was also performed. Dr. Stanford found that only 18.5% of urine samples tested positive for UTI. It is somewhat normal for women to be provided antibiotics on the basis of a phone call rather than with culturing. Dr. Stanford urged both patients and doctors to "recognize that if they are having recurrent UTI's, they may have an underlying bladder dysfunction that may be IC." He strongly suggested additional testing prior to the administration of antibiotics.

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If there is just one article that we would recommend that you read, it is Interstitial Cystitis- Characterization & Management of this Enigmatic Disease. (Summer 2002, Reviews in Urology ) Written by Curtis Nickel MD, this is the best article written on IC to appear on the internet in years.

• Coping Strategies in Patients with Interstitial Cystitis: Relationships with Quality of Life and Depression.
  J Urol 2003 Jan;169(1):233-236
• Interstitial cystitis and prostatitis. Weidner W, Fall M, Bjerklund Johansen TE.
  Eur Urol 2002 Dec;42(6):I-XI
• The prevalence of interstitial cystitis in gynecologic patients with pelvic pain, as detected by intravesical potassium sensitivity. Parsons CL, et. al.
  Am J Obstet Gynecol 2002 Nov;187(5):1395-400
• Pitfalls in the design of clinical trials for interstitial cystitis. Propert K, Payne C, Kusek J, Nyberg L
  Urology Volume 60, Issue 5 November 2002 Pages 742-748
  
  

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(Editors Note: This is one of the most difficult topics that I've covered for the IC Network because it has challenged every belief that I had about an "old school" therapy used for IC - Clorpactin. From our founding days, the goal of the ICN was to introduce patients to the many therapies used for IC as neutrally as possible. That said, I will admit that I had lost my neutrality about this therapy years ago. From the day that I was diagnosed, I had patients telling me horror stories about how painful and damaging the procedure was. Doctors that I normally networked with rarely brought it up as a treatment option. As an IC Support Group Leader, I followed the pack and passed along what I now know was poor information. In this interview, my intent is to set the record straight with the assistance of Alfred Globus, CEO of United- Guardian, Inc. He has patiently and thoroughly explained how Clorpactin was developed, how it is safely used today throughout medicine and how, to our mutual frustration, it was used at a higher, far more painful concentration than what the company recommended. We also will address the "myths" of Clorpactin and correct many of the common errors found in literature today. The ICN is not being paid to promote Clorpactin nor did they approach us to do this lecture. - Jill Osborne)

Title: The Truth About Clorpactin
An Interview with Alfred Globus, D.Sc., CEO of United-Guardian, Inc.
Date: December 2002

Clorpactin® (WCS-90) solutions are commonly used throughout the medical community as a lavage or wash that, at very low concentrations, can clean wounds, sinuses, and remove the necrotic debris from massive infections. During surgical procedures (i.e. appendix rupture), it is used as an irrigant because it kills bacteria, fungi, and some viruses. Recent research studies have shown that it also has effectiveness in the treatment of oral diseases, such as canker sores, gingivitis and periodontal disease. So, how could a therapy that is safely used in the mouth and in open abdominal incisions be described as "harmful, damaging, and bleach-like" for the bladder? A look at the history of the use of clorpactin will reveal that much of the information we have today is incorrect.

Grannum Sant, MD and Dennis La Rock, in "Intravesical Therapies for Interstitial Cystitis"¹ described the early use of Clorpactin® in the bladder. "The initial rationale for the use of Clorpactin in the 1950's was based on the similarity between the 'classic form' of interstitial cystitis with…tuberculosis of the bladder. Clorpactin® was used to treat bladder tuberculosis and this led to its use in interstitial cystitis based on the unsubstantiated belief that IC is caused by unidentified bacteria." Yet, even in those earliest days, pain was a consideration that the manufacturer took very seriously. Alfred Globus, CEO of United- Guardian, Inc., offered "When Clorpactin® was first used in the bladder for tuberculosis cystitis, it was done with a 0 .33% solution. However, we found that this concentration was too high because it caused profound pain. However, most patients could tolerate a 0.2% solution much more comfortably and still receive the same results after a series of 4-6 weekly instillations. Therefore, we've only recommended the 0.2% concentration for use in the bladder."

Yet, during the 1970's, the treatment protocol for IC was dramatically changed when researchers in New Zealand began using a 0.4% solution as a single instillation in combination with a hydrodistention of the bladder, rather than doing weekly instillations at 0.2%. The New Zealand protocol was significantly more painful and also required general anesthesia. Not surprisingly, this new method & approach became popular in America where doctors at leading universities began using this "more efficient" method of delivery. Dr. Globus reiterated: "Our recommended course of treatment involved a series of office visits at 0.2% about four or five days apart, filling the bladder comfortably without over distention. In New Zealand, they deviated from this protocol by making it a single application at 0.4% with hydrodistention. It's not only the pain caused by the 0.4%, but also the act of stretching the bladder. We did not change our viewpoint. We knew that it was too painful to exceed 0.2% and we did not recommend that increase. The point is that when someone changed the technique on their own ( i.e. 0.4%) that hurt everyone. It's not just twice as difficult to tolerate, it's probably four times as painful. The square of the increase (two squared)."

Why would it be done at the higher dose than at the lower dose? Some care providers would argue that it saved the cost of several office visits. Others would say that it was as equally effective as the lower dosage. We wonder, though, if the patient experience was disregarded. Would a patient agree to have a therapy that was very painful when a much less traumatic method of using the same medication was also available? Likely not.

Roughly around the same time, Clorpactin® also became known for causing tissue destruction and nerve damage which, according to Dr. Globus, has no basis in fact. For example, one popular IC book compares Clorpactin® and Silver Nitrate as "caustic" bladder solutions that damage the bladder surface and/or destroy the nerves in the bladder. Clorpactin and silver nitrate are not as similiar as we thought.

Question: Are Clorpactin® and silver nitrate similar?

(Dr. Globus) No, they are not similar at all. Silver nitrate is caustic. It combines with the tissue and, if it's strong enough, it will kill the tissue. Clorpactin® is not caustic. Its pH is slightly below neutral and it doesn't burn away the tissue. I personally would never allow silver nitrate to be used in my bladder if the need existed.

Question: Is Clorpactin® chemically similar to dilute chlorine bleach?

(Dr. Globus) Chlorine bleach is highly alkaline. It has a very high pH. That makes it entirely different from Clorpactin® which is just below neutral. The pH of bleach can be has high as 10 or 11. Clorpactin is about 6.6 on average. In addition, chlorine bleach has no ability to penetrate tissue, which is one of the most important actions of Clorpactin®. Clorpactin® is a powerful penetrant that can reach into crevices and fissures. Chemically, they are very different.

Question: Is there any evidence that Clorpactin® causes scarring?

(Dr. Globus) No. It should not cause scarring at 0.2%. We know it causes slight irritation to the tissue of the bladder but not permanent harm. Clorpactin® will destroy a single cell if it can surround it entirely but solid tissue is not harmed with a 0.2% solution because those cells are in a group. Healthy bladder tissue (i.e. the bladder lining) should not be destroyed when the proper strength solution is used. The bladder is a sensitive area which requires the professional to monitor the pain threshold in individual patients and adjust the procedure both in terms of dosage and strength as needed. With the exception of a recent incident that came to our attention less than one year ago, where it was alleged that Clorpactin caused damage to a bladder that was in very bad shape prior to the instillation of Clorpactin, we have no knowledge of any cases of permanent damage to the bladder. This particular case involved over distention of the bladder which, along with the use of a 0.4% solution and excessive duration of treatment, are the main causes of the negative reports that have circulated. There were also many other factors involved in this case, including the use of excessive instillation pressure and a long history of bladder problems, so it never was determined whether or not Clorpactin was responsible for the bladder damage, but it certainly did not help that the physician used procedures that we would not have recommended.

Question: Does it damage the nerves?

(Dr. Globus) Contrary to mistaken notions, Clorpactin® does not destroy nerves, for if it did, the patient would feel no pain after the procedure or at least less pain if there was only partial nerve damage.

Question: Is there any evidence that Clorpactin® would stimulate the growth of more nerves?

(Dr. Globus) I've never heard of that but it doesn't make sense. There is no evidence that this is the case and Clorpactin has been studied and used for over 45 years.

Question: Does it slough off tissue or remove the bladder wall??

(Dr. Globus) If that were the case, we would see that tissue. Instead, we see a clear fluid drain out of the bladder after the procedure. That tells us that the bladder wall remains intact.

Question: Do you consider Clorpactin® poisonous?

(Dr. Globus) A form of Clorpactin similar to WCS-90, called Kasdenol, was marketed as an oral mouthwash and gargle for 40 years. We can definitely conclude from this, from oral LD50 tests, and from toxicity work done in the United Kingdom in connection with the approval of Clorpactin in the treatment of animal mastitis, that Clorpactin is not poisonous. This is why we're doing studies right now on the use of Clorpactin® in diseases of the mouth. There was also a study on oral canker sores (herpes). Now we're doing studies with gingivitis/periodontal disease and that looks very promising as well. The first study was excellent and we're in the process of conducting further research.

Question: Some doctors won't use Clorpactin®. Why?

(Dr. Globus) Probably because they've heard that it causes pain and they are unaware that the original studies using 0.2% were successful and not nearly as painful. I think that if more doctors were aware of the tremendous number of successful uses of Clorpactin over the past 40 years when it is used properly, that they would be much more likely to use it. Unfortunately, the many success stories are sometimes overshadowed by the relatively rare problem cases. Hopefully this article will make both physicians and their patients feel better about trying this treatment at the lower concentration, thereby enabling many more to benefit from a treatment that has helped so many people over the past 40 years.

Question: How does Clorpactin® work specifically?

(Dr. Globus) It's a combination of penetration and oxidation. Clorpactin® is a very effective wetting agent, which causes penetration. More importantly, Clorpactin is an excellent oxidizing agent. It is more powerful than hydrogen peroxide. I think it's the combination of the two effects that is doing the job. The material is capable of penetrating into the interstitial portions of the cell.

Question: Given the fact that IC is not bacterial in nature, why do you think it will help an IC patient?

(Dr. Globus) For some reason, we found that patients who did not have infection still have a positive response to the therapy. We suspect that it is adding oxygen to the tissue. It's interesting that one doctor explained to me that he starts patients off with 0.1% solution so that they became inured to it. He felt that they respond better by getting used to the material first. He then goes to a 0.2% solution on the second visit, but never higher.

Question: How many treatments at 0.2% does it take?

(Dr. Globus) It's probably five or six. It's not a particularly painful procedure. Not like 0.4% and if you start off with the lowest dose, the patient gets more used to it. But, they must NOT exceed 0.2%. We also found that if you wait too long between treatments, such as 10 days or more, you have to start at the beginning again.

Question: Has a Clorpactin® instillation ever been combined with other instillations to make a "cocktail" such as DMSO cocktail?

(Dr. Globus) It can't be for the simple reason that the Clorpactin® would oxidize the additive. It wouldn't have any activity left to help the bladder condition. One doctor suggested mixing it with antibiotics. That won't work. The full antimicrobial spectrum that is killed by the Clorpactin® makes it unnecessary to add an antibiotic even if the two were compatible. You can't add anything to Clorpactin® but water or saline.

Question: Are there any circumstances where a patient should not use Clorpactin®? Contraindications?

(Dr. Globus) It can't be absorbed into the bloodstream. It's not generally allergenic at all. If the doctor starts at the lower concentration (0.1%), he can determine the ability of the patient to tolerate it. If the patient complains that it is painful at that low concentration, they probably shouldn't have the higher doses and treatment may need to be discontinued.

Question: If a patient experiences mild discomfort what should they do?

(Dr. Globus) Analgesics such as Tylenol®, Motrin® or aspirin should easily control mild pain.

Question: Finally, can you summarize for us the proper method of using Clorpactin to treat Interstitial Cystitis?

(Dr. Globus) First, do not use a concentration higher than 0.1% for the initial treatment and 0.2% for subsequent treatments. Have the patient empty his or her bladder as completely as possible and then perform a cystoscopic examination to make sure that there are no perforations or tears in the bladder. Fill the bladder to capacity (but do not over distend) using gravity feed at a pressure not to exceed 30 cm, and allow a total dwell time of 2-3 minutes per instillation. Perform 2-3 instillations per treatment, allowing several minutes between instillations. Repeat this procedure every 4-5 days for at least 5 treatments. Improvement should be seen by the fifth treatment, but seven or eight treatments may be necessary. If a period of 10 days or more elapses between treatments, the series of treatments should begin again. If the treatment is successful the results may last from several months to as much as a year or more before treatment may have to be repeated. Mild to moderate pain is not unusual and can be treated with an OTC analgesic, but a stronger prescription analgesic may be required.

CONCLUSION -
As the founder of the ICN and as an IC Support Group leader, much of my working day is spent on the phone with patients struggling with IC flares and/or pelvic pain. Like many of you, I have also called my doctor crying for relief and I know, first hand, just how frustrating and frightening it can be. Early in my diagnosis, I asked if bladder removal could be done. My urologist thankfully said "No" and rightly so. I had not tried any of the therapies for IC at that time. Although it took patience and determination, I did find the therapy that worked for me and dramatically improved my symptoms. So, if you are an IC patient contemplating surgery, I hope that your doctor will give you similar guidance. Clorpactin is one of several therapies that may be worth exploring.

References:
1 LaRock, D, Sant G., "Intravesical Therapies for Interstitial Cystitis" Interstitial Cystitis, Lippincott-Raven Publishers 1997, p. 250

Additional reading:
The company (United-Guardian, Inc.) has a booklet which can be requested and mailed to medical care providers. This booklet is specifically for physicians.

Contact Information:
United-Guardian, Inc., 230 Marcus Blvd., P.O. Box 18050, Hauppauge, NY 11788
Phone: (631) 273-0900 Fax: 631 273-0858
E-mail: evp@u-g.com

Alfred Globus, D.Sc. is the CEO of United-Guardian, Inc. He is a chemist and has worked in the industry for the past sixty years.

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Safety Alert for Patients with Implanted Leads
On December 19, 2002, the FDA issued a Public Health Notification on diathermy interactions with implanted leads and implanted systems with leads. Laboratory testing has shown that patients with any implanted metallic lead are at risk of serious injury when exposed to shortwave or microwave diathermy therapy. This is true even if the implanted device is not turned on, and even if the lead is no longer connected to an implanted system. Interaction of the diathermy energy with the implanted lead causes excessive heating in the tissue surrounding the lead electrodes. Shortwave or microwave diathermy SHOULD NOT BE USED on patients who have ANY implanted metallic lead, or any implanted system that may contain a lead. Both the heating and non-heating modes of operation pose a risk of tissue destruction. If you are a patient who has had any leads implanted via Interstim or ANS, you should take notice of this alert. Please be sure that your doctor is aware of this alert. If you have had your device removed, please ask your physician if any leads were left in your body that could be involved. Read the official FDA Notice Here!

How to Spot Quacks On the Internet
Every month, we receive phone calls and emails from patients asking about "alternative supplements" that promise to "heal" the body. Usually, this involves "detoxification" or vitamins. There appears to be an increasing trend to charge patients for phone consultations. Given that we're starting a New Year, we thought we'd reprint highlights of "Twenty-Five Ways to Spot Quacks and Vitamin Pushers," one of the best consumer awareness articles that we've found on-line, courtesy of quackwatch.org.

When Talking about Nutrients, They Tell Only Part of the Story
Quacks tell you all the wonderful things that vitamins and minerals do in your body and/or all the horrible things that can happen if you don't get enough. Many claim that their products or programs offer "optimal nutritional support." But they conveniently neglect to tell you that a balanced diet provides the nutrients people need and that the USDA food-group system makes balancing your diet simple.

They Say That Most Diseases Are Due to Faulty Diet and Can Be Treated with "Nutritional" Methods
This simply isn't so. Consult your doctor or any recognized textbook of medicine. They will tell you that although diet is a factor in some diseases (most notably coronary heart disease), most diseases have little or nothing to do with diet.

They Promise Quick, Dramatic, Miraculous Results.
False promises of cure are the quacks' most immoral practice. They don't seem to care how many people they break financially or in spirit -- by elation over their expected good fortune followed by deep depression when the "treatment" fails. Nor do quacks keep count -- while they fill their bank accounts -- of how many people they lure away from effective medical care into disability or death.

They Use Disclaimers Couched in Pseudomedical Jargon
Instead of promising to cure your disease, some quacks will promise to "detoxify," "purify," or "revitalize" your body; "balance" its chemistry or "electromagnetic energy"; bring it in harmony with nature; "stimulate" or "strengthen" your immune system; "support" or "rejuvenate" various organs in your body; or stimulate your body's power to heal itself. Some approaches to "detoxification" are based on notions that, as a result of intestinal stasis, intestinal contents putrefy, and toxins are formed and absorbed, which causes chronic poisoning of the body. This "autointoxication" theory was popular around the turn of the century but was abandoned by the scientific community during the 1930s. No such "toxins" have ever been found, and careful observations have shown that individuals in good health can vary greatly in bowel habits. Quacks may also suggest that fecal material collects on the lining of the intestine and causes trouble unless removed by laxatives, colonic irrigation, special diets, and/or various herbs or food supplements that "cleanse" the body. The falsity of this notion is obvious to doctors who perform intestinal surgery or peer within the large intestine with a diagnostic instrument. Fecal material does not adhere to the intestinal lining.

They Use Anecdotes and Testimonials to Support Their Claims
We all tend to believe what others tell us about personal experiences. But separating cause and effect from coincidence can be difficult. If people tell you that product X has cured their cancer, arthritis, or whatever, be skeptical. They may not actually have had the condition. If they did, their recovery most likely would have occurred without the help of product X. Most single episodes of disease end with just the passage of time, and most chronic ailments have symptom-free periods. Establishing medical truths requires careful and repeated investigation -- with well-designed experiments, not reports of coincidences misperceived as cause-and-effect. That's why testimonial evidence is forbidden in scientific articles, is usually inadmissible in court, and is not used to evaluate whether or not drugs should be legally marketable.

They Offer to Determine Your Body's Nutritional State with a Laboratory Test or a Questionnaire.
Various health-food industry members and unscientific practitioners utilize tests that they claim can determine your body's nutritional state and -- of course -- what products you should buy from them. One favorite method is hair analysis. Other tests used to hawk supplements include amino acid analysis of urine, muscle-testing (applied kinesiology), iridology, blood typing, "nutrient-deficiency" and/or lifestyle questionnaires, and "electrodiagnostic" gadgets.

They Claim They Are Being Persecuted by Orthodox Medicine and That Their Work Is Being Suppressed Because It's Controversial.
The "conspiracy charge" is an attempt to gain sympathy by portraying the quack as an "underdog." Quacks typically claim that the American Medical Association is against them because their cures would cut into the incomes that doctors make by keeping people sick. Don't fall for such nonsense! Read the entire Quackwatch article today!

Update on Colloidal Silver
Yet another fad which has swept through the on-line IC community for the past seven years is the use of colloidal silver. In October 16, 1999, the FDA banned the use of colloidal silver or silver salts in over-the-counter products that claim to be effective in preventing or treating any disease. To date, more than 20 companies on the web have received warnings from the FDA for making inappropriate and illegal therapeutic claims for their colloidal silver products. Silver products can still be sold as "dietary supplements" provided that no health claims are made for them. Read more!

Is Sugar A Treatment for IC? No!
One of the most disappointing events on the internet in 2002 was a company that began selling an expensive sugar "D-Mannose" as a preventative treatment for IC. Yes, sugar! Do we look stupid? Their web site said "Although there is no clinical evidence that it can be effective in every or even most cases (emphasis ours), we have received anecdotal evidence..." As stated in the article from quackwatch, anecdotal evidence is relatively meaningless. We challenge that company to prove their absurd claims by conducting a research study with IC patients rather that just guessing that it might work. Save your money for alternatives that do have research demonstrating effectiveness at reducing the symptoms of IC.

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FRESH TASTES BY BEV -
http://www.ic-network.com/bev/

Holiday Flares, Nutrition & Tricyclics
This month, Bev covers an unusual source for holiday flares - Vitamin B2 deficiencies from various medications including antidepressants commonly used by IC patients. She tells the story of a patient in her support group who struggled greatly with this. She covers how to recognize a deficiency and how to find B2 friendly foods. She also discusses more about drug/food interactions, especially from dietary supplements. Read the full article & review the references here!

IC LIFESTYLES BY Gaye & Andrew Sandler -
http://www.ic-network.com/iclifestyles/

The Princess (or Prince) & the Pea - Part II - Insomnia & IC
The 2nd part of a two series, this column is perfect for patients who are struggling with sleep and insomnia. It covers several topics, including: medications to help patients sleep, mattresses and pillows, breathing problems, diet and sleep, hunger, and exercise and sleep. Don't let yourself become sleep deprived. Read the full article here!

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(Submitted by Jill Osborne, ICN Founder) 2002 was a busy year in the ICN offices with thousands of phone calls from patients who were struggling with symptoms. One patient in particular stands out. I'll call him Jeff. He's a young, vibrant professional in his 30's whose life was at a stand still due to pain. No matter what he tried, his symptoms were excruciating but they were also unusual. He didn't flare with diet at all. When he woke in the morning, he felt quite good but within 30 minutes of getting up, the pain and discomfort would continue.

Now Jeff is a dedicated patient. He tried nearly everything suggested by his doctors, who were very informed and up to date on IC. He scoured the internet for information and followed virtually every treatment pathway that he could find, from traditional therapies to alternatives. Nothing seemed to work.

Let me just remind you all. Try to go back to the beginning and keep a written record of your symptoms and treatments. It may be that one simple event might put it all together for you and your doctor. Keep a voiding diary and write down patterns that you might observe with your symptoms. Are they worse at night?? or during the day?? Do any specific activities make them worse???

In Jeff's case, his symptoms were the worst when he was sitting. In fact, they occurred only when he was sitting. That, together with the fact that his bladder didn't behave like an IC bladder (i.e. respond to acid or salty foods, alcohol) and that no therapies offered relief, opened the door to the possibility that he may have a Pudendal Nerve Entrapment (PNE) instead. Why? His symptoms are positional.. They are worse when he is sitting or driving. They disappear when he is laying down or standing. Jeff dove into the information and found that he had all the symptoms of PNE. His urologist now considers this a strong possibility. So, let's take a closer look at this condition which could, for some of you, be a source of your pain and discomfort.

Pudendal Nerve Entrapment (PNE) is a rare condition that causes pain for no apparent reason in the lower central pelvic areas, including the anus, perineum, scrotum and/or vulva. The classic symptom of PNE is pain upon sitting, that is relieved or less when standing or sitting on a donut cushion or toilet seat. Pain can be in just one area, several, or all. It can be one sided or on both sides. It has been described as stinging, burning, stabbing, aching, knife-like, irritation, cramping, spasm, tightness, crawling on the skin, twisting, pins and needles, numbness, and hyper sensitivity. It can also feel as if something is inside the rectum or vagina. Obviously it becomes difficult for patients to do activities which require sitting.

PNE is caused by entrapment (constriction, rubbing, stretching) of the pudendal nerve at various places along the nerve. The nerve then responds with irritation, inflammation, scarring, and/or thickening. Ultimately, the nerve may not function properly and cause a wide variety of problems including difficulty with urination, constipation and even sexual problems. PNE is usually precipitated by prolonged sitting or trauma to the sitting area, combined with a genetic and developmental susceptibility. PNE is so common in long distance bicyclists that it's nicknamed Cyclist's Syndrome. The prolonged sitting pressure, the continual nerve rubbing and stretching from pedal pumping, and the extremely high seat pressure form the ideal conditions for PNE.

PNE is diagnosed by presence of the classic symptoms and the exclusion of other factors like disease or injury. The final criteria is the use of nerve blocks, which are also effective at curing the condition in roughly two thirds of the patients with PNE. Unfortunately, the longer the pudendal nerve is irritated, the less likely steroid injections will cure the condition. Surgery can then be performed to release the nerve.

If you do feel that PNE can be a contributing factor for you, there are several resources, message boards & mailing lists available on the internet that will help you learn more about the condition and locate the few specialists available in the world. Most importantly, PNE sufferers recommend that you minimize your sitting time... and, when you do sit, use a cushion with a center cutout. You can also tilt your seat angle forward or lean forward which then puts more weight on your thighs and off your crotch.

Learn more about PNE at:
Pudendal Neuropathy Support Community
Pudendal Nerve Entrapment Frequently Asked Questions
Pudendal Neuralgia

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2003 IC Survival Guide Library Campaign

Our goal for 2003 is to bring the best IC resource that we can find to libraries throughout the USA so that patients who are low-income will have access to the best information on IC. What book could be better than Robert Moldwin's IC Survival Guide, which has been popular with both patients and providers since its publication! We hope that you will help make this happen by sponsoring a book to be donated to a library of your choice. Each book will have a certificate of donation attached to the title page.

Read more about this special program today in the ICN! Your sponsorship of a book can make a world of a difference to patients in your town! If not you, then who?

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(J) IC Support Opportunities http://www.ic-network.com/chat/ The ICN now offer four support group meetings a month, led by a compassionate team of support group leaders. We hope that they offer you comfort, encouragement and hope.

OUR 2003 SUPPORT CHAT SCHEDULE!

The Latest IC News & Updates - January 14, 2003 with ICN Manager Jill

We're having a special support chat on Interstim & Neuromodulation on Tuesday, January 28, 2003. We'd like to have patients who have had the device implanted, as well as those who are considering it, to attend. We'll take questions on the pros & cons of the device, known complications, how to prepare for procedures, long term issues after implantation, FDA guidelines and an update on the litigation by several patients in Colorado who had sued their doctor and hospital after surgery. This meeting will be focused, as well, on interstim support issues.

Newbie Chats: Mondays 4PM PST, 7PM EST
1st & 3rd Mondays - Newbie Orientation for newly diagnosed patients

Evening Topic & Support Chats: Tuesdays 5PM PST (8PM EST)
2nd Tuesday & 4th Tuesdays

If you are a first time visitor we encourage you to join in on the discussion. We welcome your thoughts, hopes, fears, tears, jokes and the support that you can offer to others living with IC. We invite and encourage a healthy exchange of opinions and disagreements. While we hope that you'll become an active participant and join in our discussions, feel free to simply hang out silently until you feel more comfortable posting a message. To our grizzled veterans, please be sensitive to the needs of newly diagnosed patients. They come into our support chats looking for encouragement and hope and that is exactly how we want them to feel when they leave. Our focus is support. No profanity or cursing please!

NEW USA SUPPORT GROUPS
http://www.ic-network.com/activism/supportgroups.html
The ICN has supported independent IC support groups for many years and are pleased to share their information and listings with our users. New groups have been added in Florida, Wisconsin, Georgia, Connecticut, Mississippi, Maryland, New Jersey, Washington, Utah, Ohio, Hawaii, Kansas, Michigan, New York & Northern California!

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WHATS NEW?
Tamer Low Acid Coffee Beans - Espresso, Decaf & Regular
Videos - The Hatha Yoga Program for People with IC by Dr. Emmey Ripold (a board certified urologist located in Minnesota) and Dawn Mahowald CYI (certified yoga instructor).
The Mitral Valve Prolapse Survival Guide
Rediscovering Romance Kit for IC patients

ALTERNATIVES & SUPPLEMENTS
The ICN has, historically, not promoted alternative therapies for IC until this past summer. Why? In the early days of the ICN, there was little research showing that they were effective. Today, we do have research studies that show their individual effectiveness. Just this past fall, yet another research study was presented showing the effectiveness of CystaQ in reducing the symptoms of IC and vulvodynia.But, there's also another motivation. In the past year, we've had several patients contact us who were told that invasive surgery was the ONLY therapy for IC, completely in contradiction to the FDA guidelines for that surgery. Frankly, this was infuriating and we realized that the ICN could spread the word that there are other therapies besides surgery, including well tested alternatives. Hence, our decision to offer these in our shop! We've also featured several of their researchers in our guest lecture series so that you can hear, first hand, how these products were developed and what research has been conducted.

Now available for purchase
CystaQ - The oldest, most well researched alternative for IC.
Algonot Plus - Developed by Dr. Theoharis Theoharides, this supplement is one of only a few (Prelief, CystaQ and the aloe below) that show effectiveness in reducing the symptoms of IC. Special offer! (Buy three or more and we'll cover the shipping!)
Desert Harvest Aloe

RECOMMENDED BOOKS
The Interstitial Cystitis Survival Guide by R. Moldwin
Patient to Patient: Managing IC and Related Conditions by Gaye & Andrew Sandler
A Taste of the Good Life: A Cookbook for an IC Diet by B. Laumann (1998)
Nolo’s Guide to Social Security Disability
The Couples Survival Workbook
Breaking the Bonds of IBS by Barbara Bolen, Ph.D. (2000)
The Chronic Pain Control Workbook by Catalano & Hardin (1996)
Relaxation & Stress Reduction Workbook, 5th ed. (2000)
Living Well With A Hidden Disability
Stop the Anger Now
Self Nourishment Companion
Shy Bladder Syndrome
Hypnotize Yourself Out of Pain
The Vulvodynia Survival Guide
NEW! Sex Talk - Uncensored Exercises for Exploring What Really Turns You On!

Please support our work by becoming an ICN subscriber. The Interstitial Cystitis Network, the largest free archive of IC information in the world, is made possible by subscribers, advertisers and purchases via the ICN Shop. Rather than ask for a membership fee up front to receive this newsletter (by e-mail), participate in our support groups and to purchase materials, we want you to use our web site and get the support you need. If, over the long term, you find that we have helped you, please support our work by becoming an ICN subscriber.

Jill Osborne, Founder & Editor
Interstitial Cystitis Network
4983 Sonoma Highway, Suite L.
Santa Rosa, CA 95409
(707)538-9442 - Voice
(707)538-9444 - FAX
E-mail: jill@ic-network.com

"I believe that people of gentleness and caring can change the world. One unseen, unsung, un-rewarded kindness at a time." - Author unknown.

The information in the IC Network is provided with the understanding that the ICN (staff, volunteers, users, columnists) are not rendering medical services. Information found in text, e-mail, message boards, chat rooms are not medical recommendations nor should they replace necessary "face to face" consultations with a qualified medical professional.