CAFÉ ICA, VOLUME 7, NUMBER 1, January 2007

This issue of Café ICA is sponsored in part by educational grants from
Medtronic, Inc.
AkPharma Inc.
Bioniche Life Sciences, Inc.
Farr Labs, LLC

Your monthly electronic source for the latest interstitial cystitis medical highlights, self-help & coping strategies, and ICA news, brought to you by the Interstitial Cystitis Association since August 2001.

In this issue...

1. Hot Off the Press
1.1 European Medical Professionals Intend to Change the Name of IC
1.2 2006 ICA Year in Review Now Online
1.3 ICA Nursing Educational Website Presentation Now Online!
1.4 ICA Represents IC at Recent International Chronic Fatigue Conference

2. Voices in the IC Community
2.1 The ICA's Recent Research Advocacy Efforts
2.2 The Medtronic Foundation Makes Donation on Behalf of Global Heroes
2.3 Great News from the Boston-MetroWest IC Support Group
2.4 Winnipeg Free Press Focuses on Local IC Sufferer

3. News YOU Can Use!
3.1 CD Available to Help Ease IC and Pelvic Pain
3.2 New Fibromyalgia Research Points to Dopamine Theory
3.3 FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
3.4 Current Clinical Trials Seeking Participants

4. The Latest IC Research Highlights

5. Upcoming Conferences

6. Products That Can Help YOU Today!

From the ICA Mailroom:

Thank you again for your kindness and assistance. I appreciate the great work the ICA is doing. If it were not for the ICA, there would be nobody leading the way regarding IC.
- Jason

1. Hot Off the Press

1.1 European Medical Professionals Intend to Change the Name of IC

During the recent National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) International Bladder Symposium: Frontiers in Painful Bladder Syndrome and Interstitial Cystitis, held in Bethesda, Maryland, on October 26 and 27, 2006, the European Society for the Study of IC/PBS (ESSIC) announced that they would be replacing the term "interstitial cystitis" with "bladder pain syndrome" and revamping the current diagnostic criteria.

ESSIC is a non-profit organization for medical professionals that was established in Copenhagen, Denmark, in June of 2004. Its members are scientists and/or medical practitioners with an interest in research into and/or treatment of IC. There are no patient members of ESSIC and we are unaware of any active participants outside of Europe and the UK. There were neither patient representatives nor any IC experts from the US at the meetings that developed the ESSIC name change and definition of IC.

In brief, ESSIC intends to:
1. Change the name of interstitial cystitis (IC) to bladder pain syndrome (BPS).

2. Establish more rigorous diagnostic testing criteria, including various tests not currently typically used in the diagnosis of IC, relying significantly on cystoscopy with hydrodistention under general anesthesia with a deep-tissue biopsy to confirm the diagnosis.

3. Remove the word "urgency" as a defining symptom of IC.

4. Include only patients who experience pain and frequency. This excludes patients who may only experience urgency, frequency, and/or pelvic pressure.

Some of the ICA's major concerns regarding the terminology change:
1. Bladder Pain Syndrome is too broad a term. For instance, people who are experiencing urinary tract infections, pelvic pain problems, and any other bladder problems that cause pain may feel that they have BPS.

2. Physicians of many specialties, medical students, and residents from urology are now aware of IC (using the term "interstitial cystitis"). This name change could have a very negative impact on their recently acquired recognition, understanding, and ability to treat the condition.

3. A terminology change away from IC at this juncture will also hurt the years that many organizations have spent working on educating the patient population, legislators, and general public about interstitial cystitis.

4. Consideration must be given to the impact of this terminology change on the US Social Security Administration's recognition and understanding of the disease as well as the ability for people with the condition to gain disability benefits, either from the SSA or privately. The SSA's Ruling was awarded for IC, not BPS.

5. A name change could impact health insurance coding for physician reimbursements, patient coverage, and pharmaceutical coverage.

6. Use of a new name could dilute/confuse or halt research funding programs and opportunities.

7. A terminology change will complicate the process of searching the medical literature on IC. Both healthcare providers and patients will have to contend with multiple terms and descriptions of the disease when they look for scientific references. Older references will likely refer to IC, whereas newer references would refer to BPS, leading to the inability to get a full and comprehensive picture of IC research without knowing that multiple terms are required. It is possible that the name change will affect which medical articles are selected for publication by urology journals since editors may reject the term interstitial cystitis and accept only bladder pain syndrome.

8. And, most importantly, the use of a new name will make it more difficult for people suffering from the condition to:

• seek information on the internet & elsewhere
• receive diagnosis and treatment
• find help from organizations such as the ICA
• get validation from friends & family

Concerns regarding ESSIC's definition/diagnostic change:
1. Since is has long been recognized that the NIDDK IC definition/diagnostic criteria were written expressly for the purpose of research studies, we realize that a revision is necessary. The US and other world IC leaders are acutely aware of this problem and have been working on this very important revision for several years.

2. While ESSIC's new name of Bladder Pain Syndrome can be seen as too broad, as stated above, ESSIC's new definition could be seen as too restrictive, excluding patients who may only experience urgency, frequency, and/or pelvic pressure, but not pain, and thus echoing the similarly restrictive NIDDK diagnostic criteria.

3. Unlike many European countries, such as England and the Scandinavian countries, the US healthcare system is not equipped/designed to provide for series of tests. Many people in the US and other parts of the world are underinsured or not insured and could not afford the proposed testing procedures. And many health insurance companies would not reimburse for additional testing.

The problem of excluding urinary urgency:
1. Focusing solely on bladder pain as the main symptom of this condition will exclude patients with urinary urgency and pelvic pressure.

2. While it is recognized that urinary urgency may need to be further refined/defined to describe the unique sensation as it applies to IC patients (as opposed to urge incontinence patients), excluding urgency altogether will not solve this dilemma. Work needs to be done on refining or redefining urinary urgency as it applies to IC. We suggest that the term pelvic pressure be substituted for urgency to avoid confusion with incontinence.

________________________________________

The ICA has a number of concerns with both the process in which ESSIC reached a consensus and the outcome of that consensus. In particular, the ICA believes that any name change or definition change of IC must include that the NIDDK and the IC experts from the US as well as the worldwide patient community. Over many years the ICA and the NIDDK have reached out to ESSIC members, as well as the wider international community, and invited them to work collaboratively with both the patient community and US researchers and clinicians. The ICA believes it is critical that there be additional opportunities for thoughtful discussion before ESSIC moves any further ahead and is committed to taking a leadership role to ensure that this happens. The ICA is confident that ESSIC will see the wisdom in having a larger team of experts review their conclusions and equally importantly, take into serious consideration the very deep concerns of the patients.

1.2 2006 ICA Year in Review

The ICA's 2006 Year in Review is now available online.
Through your generous support and the dedication of the ICA's Board of Directors, Medical Advisory Board, volunteers, and staff, the ICA has once again achieved unprecedented goals and accomplishments.

Thank you!

Please click here to view this year's report.

1.3 ICA Nursing Educational Website Presentation Now Online!

We are pleased to present the first in a series of online ICA medical education tools to assist healthcare professionals in becoming familiar with all aspects of IC. This presentation, Interstitial Cystitis: What Healthcare Providers Need to Know, is designed to further educate the nursing community about IC and was underwritten by a generous educational grant from The Medtronic Foundation.

Click here to view:
http://www.ichelp.org/nursingpresentation/ICANursingPresentation.pdf

1.4 ICA Represents IC at Recent International Chronic Fatigue Conference

In early January, the ICA made a first-ever appearance at the 8th International Association for Chronic Fatigue Syndrome (IACFS, formerly the AACFS) Conference on Chronic Fatigue Syndrome, Fibromyalgia and other Related Illnesses in Fort Lauderdale, Florida. There were two back-to-back events: a two-day patient event with more than 320 attendees and a three-day medical professional event with more than 350 attendees. The ICA was an exhibitor for both of these programs.

The professional conference segments focused on pathophysiology and treatment in an effort to "unravel the enigmatic interrelationship of the various immunologic, neurologic, endocrinologic, and cardiovascular abnormalities." There were lectures on the latest research, newest clinical protocols, genetics, and the outlook for future research. The patient conference addressed similar themes, along with introductory and breakout lectures designed exclusively for patients to understand how to manage their own health issues and how to strive for optimal health.

Karen Berkley, PhD, a longtime ICA supporter and friend who specializes in the study of pelvic pain syndromes at the University of Miami, was a featured speaker at the professional event and spoke briefly about IC, which is one of the related diseases that people with chronic fatigue immune deficiency syndrome (CFIDS) experience with greater frequency than do people in the general population.

From the ICA Mailroom:

My family doctor only informed me of your website approximately one year ago. It has been very informative for me and the support is phenomenal that I get from email. I am so grateful that being Canadian I have access to your support and answers to my questions. I cannot stress my gratitude enough to the wonderful individuals that have given their time and energy to assist/inform on this disease. -Kimberley R.

2. Voices in the IC Community

2.1 The ICA's Recent Research Advocacy Efforts

The ICA knows the value of a continued strong investment in IC research from the federal government and its importance to all people with IC. ICA Founder and President Emeritus, Vicki Ratner, MD met regularly with policy-makers and important decision makers at the National Institutes of Health (NIH) in Washington, DC to discuss the future of IC research. Currently, the NIDDK is the branch of the NIH that is responsible for carrying out all federally funded IC research.

In the last three months alone, Dr. Ratner met twice with the Acting Director of the NIDDK, Griffin Rodgers, MD, and his Senior Scientific Adviser for Translational Biology and Acting Director of the Division of Kidney, Urologic, and Hematologic Diseases (KUH), as well as their team of IC advisors, to map out the future of IC research over the next five years. These conversations and the many follow-up ones are critical in securing funding for IC research annually and in advancing a long-range plan that will help us unlock the IC mystery.

The ICA conveyed the importance of new funding allocations for IC research at the federal level. IC-specific funding is needed to focus on the basic science of IC and to attract and sustain research in the field.

Also discussed during the meeting was the lack of clarity surrounding the definition of IC. The ICA asked that the NIDDK help to foster the dialogue and process which would lead to the development of a new research definition of IC to clarify the investigative questions and ensure that the research results are comparable and therefore, more meaningful.

2.2 The Medtronic Foundation Makes Donation on Behalf of Global Heroes

The Medtronic Foundation recently donated $1,000 to the Interstitial Cystitis Association on behalf of Medtronic Global Hero Laura Santurri. Laura is an avid runner with interstitial cystitis/painful bladder syndrome, and she is living a full and active life with the help of Medtronic's InterStim Therapy, a medical device approved for various bladder control problems and prescribed by her doctor. She was chosen by Medtronic to be part of its inaugural class of 14 Global Heroes after a worldwide search for runners whose lives have been improved with the help of medical device technology.

Winners received paid entry into the Medtronic Twin Cities Marathon and Medtronic TC 10 Mile race on October 1, 2006, as well as a spending allowance to help cover travel, lodging and meal expenses for out-of-town participants. As part of the Global Heroes Program, the Medtronic Foundation donated $1,000 to a nonprofit patient organization, on behalf of each runner.

"Medtronic has a long and proud tradition of helping people with chronic health conditions to live full and actives lives," said Dr. Steve Oesterle, Medtronic Senior Vice President of Medicine and Technology and veteran of 12 marathons. "Whether it's just one mile, 10 miles or 26 miles, we hope these Global Heroes inspire others to follow in their footsteps."

With the help of the InterStim Therapy, Laura was able to successfully complete the rigorous Medtronic TC 10 Mile race. She completed the course in 2:01:18.

Laura's Story about Living - and Running- with IC/PBS

Laura Santurri was an avid runner for most of her life. But on December 27, 1997, her life changed dramatically. She woke up with excruciating pain that, at first, she thought was a bladder infection. Laura sought medical help and was diagnosed with interstitial cystitis/painful bladder syndrome. Over the next few years, her pain intensified and she says her health was "spiraling downhill," as she gained weight and took up smoking.

Then in 2004, Laura met a doctor who suggested trying Medtronic's InterStim Therapy. The therapy involves implanting a medical device called a neurostimulator to deliver mild electrical stimulation to the sacral nerves which are located in the lower back and influence bladder function.

"When I decided to have the implantation done in 2005, my life changed again - but this time for the better," Laura recalled. "I woke up the next morning and went to the bathroom with no pain. I thought maybe it was a fluke, but this relief continued."

With this newfound reprieve from pain, Laura decided to take her life back. She quit smoking, started eating healthier and became physically active again. She also returned to running. She ran the Cleveland Rite Aid 10K two years in a row and raised more than $1,000 in pledges from her supporters for the Interstitial Cystitis Association.

After she completed the Medtronic TC 10 Mile, Laura said she was overwhelmed by the support of Medtronic during the event.

"Race day was amazing!" Laura said. "I couldn't believe how many Medtronic employees were out there supporting the runners. When I heard one of them yell, 'We've got a Global Hero coming!' as I ran past the three-mile mark, it gave me such a boost of energy. Most importantly, Medtronic made it possible for my father to be at the finish line. I cannot express how much it meant to look over and see him cheering for me. It was one of the proudest and most inspirational moments of my life. I hope that other IC patients can find hope in the fact that I was able to finish that race I want all IC patients to know that they can overcome this disease, persevere, and fulfill their dreams."

Our thanks to Laura and Medtronic for their dedication and determination. They are an inspiration to us all.

For more information on how to apply or nominate someone to be a Medtronic Twin Cities Marathon Global Hero, email mtcm.globalhero@medtronic.com. All runners with medical devices are welcome to apply with no restriction on manufacturer.

2.3 Great News from the Boston-MetroWest IC Support Group

Molly Glidden, leader of the Boston-MetroWest IC Support Group, recently shared this inspiring story with us and we wanted to share it with you, our readers:

I want everyone to know that our profit for the year 2006 after expenses was $250.00. We have sent a $50.00 donation to the senior center (Friends), for allowing us their space for our yearly meetings. We have also sent $200.00 to the ICA from our group. I believe that if it weren't for the work of the ICA, interstitial cystitis would not have been legitimized, especially within our medical professional communities. The ICA has done a great job getting this disabling condition recognized all over the world in order to get the much needed research for us!

Thank YOU for your dedication and faith in the ICA, Molly! You are amazing!

2.4 Winnipeg Free Press Focuses on Local IC Sufferer

The January 8th edition of the Winnipeg Free Press ran a moving account of IC sufferer, Janice Starodub, a local Winnipeg, Manitoba, Canada resident who, after a 15 year reprieve from her more debilitating IC symptoms that first developed in the early 1990s, is now in severe chronic pain and desperately seeking relief.

The article is entitled, Chronic Illness Leaves Woman in Constant Pain: Doctors Unable to Treat Condition in Manitoba.

To read the article in its entirety, please click here:
http://www.winnipegfreepress.com/subscriber/life/story/3834799p-4437281c.html

3. News YOU Can Use!

3.1 CD Available to Help Ease IC and Pelvic Pain

Donna Carrico, who led the pilot study that showed reduction of pain in women with IC and pelvic pain with guided imagery, is a nurse practitioner who works with Ken Peters, MD, and other urologists who treat IC at William Beaumont Hospital. Ms. Carrico developed the CD Guided Imagery for Relaxation in Women with Pelvic Pain or IC based on her experience that these techniques really helped to reduce pain in labor and delivery.

Research has shown that guided imagery that is very specific to the parts of the body that need healing does better than very general relaxation at promoting healing responses and managing pain, said Ms. Carrico. When she looked for a relaxation CD to use with her women patients with IC and pelvic pain, she realized that the CDs weren't specific enough. "They really didn't have much to do with the pain I was hearing," she said. So, she wrote a script specifically for IC and pelvic pain patients that uses the words her patients did to describe how they felt.

Working with Gail Elliott Evo, a certified hypnotherapist in William Beaumont Hospital's Department of Integrative Medicine, Ms. Carrico produced the 50-minute CD. The recording has two tracks, one titled "Just Breathe" for more general relaxation and a second titled "Letting Go" that's very specific for IC and pelvic pain. The second track lasts about 30 minutes, starting with a few minutes of music introduction and about 10 minutes of imagery to promote deep general relaxation. Then, the imagery turns to the bladder, pelvis, vagina, back, legs, and even nerves, suggesting the absence of urgency and promoting feelings of warmth, melting tension, protection from pain, and refreshment. Self-acceptance, kindness, forgiveness, and inner peace are also a focus of the script. The music and dialogue then help the listener come back to a more wakeful and refreshed state, and the music continues for five minutes or so.

But don't worry if you fall asleep, said Ms Carrico. "There's some research that shows the imagery is actually still effective because the message gets into your subconscious mind."

To patients who worry that doctors might recommend this instead of helping them medically with their pain, Ms. Carrico says that this technique should be only a part of multimodal therapy. Medications and physical therapy are also critical in managing IC and pelvic pain. The CD is simply a very available, cheap, and effective tool that adds to pain management.

The next step in her research of this technique for pelvic pain will be a pilot study that will look to see if using the CD can change levels of biomarkers of inflammation in saliva in women with IC and pelvic pain. (Go to Clinical Trials.gov: http://www.clinicaltrials.gov/ct/show/NCT00420550?order=8) Although this is a small, mostly local study, the William Beaumont team hopes to expand it nationwide if the pilot study results are positive.

In order to obtain this CD we ask that you make a donation (minimum of $15) to the Beaumont Women's Initiative for Pelvic Pain and Sexual Health (WISH) program. In addition to receiving the CD you will also be kept informed of research studies and other news about our WISH program.

Please contact us by phone, email or online:

Online:
https://beaussl.beaumont.edu:4446/pls/portal/foundation.foundation_form

Make a note in the comment field that this is a donation to the WISH program and that you are interested in the CD

Email
mmkelly@beaumont.edu or llampkins@beaumont.edu

Send an email, and you'll be sent an order form

Telephone
(248) 551-3565

3.2 New Fibromyalgia Research Points to Dopamine Theory

FOR IMMEDIATE RELEASE
4 January 2007

"Fibromyalgia: Show Me Where It Hurts"
New Study Links Fibromyalgia to Reduced Brain Dopamine

ORANGE, Calif---- 4 January 2007---- The National Fibromyalgia Association today announced that a new study published in the January issue of The Journal of Pain provides new scientific evidence demonstrating for the first time that there is a fundamental difference between the brains of fibromyalgia patients and healthy individuals not afflicted with the disorder.

The study's lead author, Dr. Patrick Wood, is a nationally recognized researcher and authority on the cause and treatment of fibromyalgia. This groundbreaking study supports Dr Wood's "Dopamine Theory of Fibromyalgia," which proposes that people with fibromyalgia produce less dopamine-a natural chemical in the body that functions as a neurotransmitter-in the very areas of the brain where dopamine is needed to process painful bodily sensations.

The reduction in the activity of dopamine neurons, believed to result from a combination of environmental factors, including chronic stress, as well as genetic factors, serves as the strongest evidence yet that dopamine-related issues may be the root cause of fibromyalgia.

"This study provides a whole new perspective on the pathology of fibromyalgia symptoms," says Wood.

STUDY
The research study used positron emission tomography (PET) to compare the capacity of fibromyalgia patients to synthesize brain dopamine in comparison with healthy controls. A total of seven female fibromyalgia patients and eight healthy controls were recruited for the study at Louisiana State University Health Sciences Center, where Dr. Wood serves as assistant professor and directs both the Fibromyalgia Research Program and the Fibromyalgia Care Clinic. The results of the study demonstrate that patients with fibromyalgia have significantly reduced dopamine synthesis in multiple brain regions.

"It's all in your head!"
For years, people with fibromyalgia have been told that their illness and symptoms were imaginary, or "all in their heads!" Indeed, fibromyalgia has divided the medical community on the subject of its legitimacy due in large part to the lack of a known cause or genetic markers.

According to the National Fibromyalgia Association, an estimated 10 million Americans are affected by the disorder. Genetic factors and exposure to chronic stress have been increasingly suspected as key factors associated with fibromyalgia. Treatment typically focuses on addressing fibromyalgia symptoms, which include widespread pain, fatigue, and sleep disturbance.

"One of the reasons fibromyalgia is considered so controversial is because we simply don't know the cause," explained Dr. Wood. "Our treatment of the symptoms has been sort of a 'shot in the dark' because we don't really understand what it is we are treating." However, based in the results of this study, there is reason to bring more emphasis on those treatments that may affect brain dopamine activity. "In effect," Wood said, "we may begin to treat the source of the disorder, and not just its symptoms."

"Fibromyalgia: Show Me Where It Hurts"
Dr. Wood's research involving the Dopamine Theory of Fibromyalgia is featured in a recently released film entitled "Fibromyalgia: Show Me Where It Hurts," which premiered at the National Fibromyalgia Association's 2006 National Patient Conference in March.

A trailer of the film can be viewed on the National Fibromyalgia Association's website: http://www.fmaware.org/.

In light of the latest results and the small initial sample size, Dr. Wood and the National Fibromyalgia Association (NFA) are urging further studies to determine the extent to which the lack of dopamine might be associated with the pain and other symptoms that characterize fibromyalgia.

"Further research on Dr. Wood's Dopamine Theory could help answer questions that could directly benefit people with fibromyalgia," said Lynne Matallana, founder and president of the National Fibromyalgia Association, the largest nonprofit association serving people with fibromyalgia and other chronic pain illnesses. Matallana, who was diagnosed with fibromyalgia in 1995, appears in "Fibromyalgia: Show Me Where It Hurts."

For the complete text of the study, visit: http://journals.elsevierhealth.com/periodicals/yjpai/current

3.3 FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers

FOR IMMEDIATE RELEASE
P06-207
December 19, 2006

The Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscle aches.

To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes:

For Products Containing Acetaminophen
To require new warnings which would highlight the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol;
To require that the ingredient acetaminophen be prominently identified on the product's principal display panel (PDP) of the immediate container, and the outer carton (if applicable).

For Products Containing NSAIDs
To require new warnings for products that contain an NSAID which would highlight the potential for stomach bleeding in persons over age 60, in persons who have had prior ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for longer time than directed; and
To require that the name of the NSAID ingredient and the term "NSAID" be prominently identified on the product's PDP of the immediate container and the outer carton (if applicable).

The new labeling would be required for all OTC drug products that contain only an IAAA ingredient, as well as for products that contain an IAAA ingredient with other ingredients, such as cold symptom relievers. Consumers may also be taking IAAA ingredients in their prescription medications, which makes it important to alert them of the contents of their OTC medications, so they do not take too much of an IAAA ingredient.

FDA based its proposal for labeling changes on previous Advisory Committee discussions, recommendations, and public comments (see http://www.fda.gov/ohrms/dockets/ac/cder02.htm#NonprescriptionDrugs) and a review of the scientific literature.

A number of manufacturers of OTC internal analgesic drug products already have voluntarily implemented labeling changes to identify these potential safety concerns.

Comments on the current proposal, to be published in the December 26, 2006 Federal Register may be sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: (http://www.fda.gov/ohrms/dockets/default.htm).

3.4 Current Clinical Trials Seeking Participants

Johns Hopkins Study:
Interstitial Cystitis Study / Researchers at Johns Hopkins Hospital are looking for women to participate in research studies concerning the mechanisms of pain in interstitial cystitis. If you are at least 18 years old and if you have been diagnosed with Interstitial Cystitis for at least 6 months you might be an appropriate candidate for these research studies. Participants will be asked to record symptoms related to interstitial cystitis in a diary at home for 4 months. Women who are pregnant or had a hysterectomy are not eligible. (Support: NIH/NIDDK; Principal Investigator: Ursula Wesselmann MD, Dept. of Neurology, Johns Hopkins Hospital.) Info: 410-614-4965; womensresearch@jhmi.edu
(RPN 97-08-15-01 Approved 10/03/2006 by JHIRB)

Allergan Study:
Safety and Efficacy of AGN 203818 for Pain Associated With Painful Bladder Syndrome/Interstitial Cystitis / This study sponsored by Allergan will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with painful bladder syndrome/interstitial cystitis.

To learn more about this study, including how you can participate, please visit:

http://www.allerganclinicaltrials.com/

http://www.clinicaltrials.gov/ct/show/NCT00380783?order=10

Plethora Solutions Study:
Phase II, multicenter, randomized, double blind, placebo controlled pilot study to determine proof of efficacy, safety, tolerability, and pharmacokinetics of intravesical PSD597 in the symptomatic management of interstitial cystitis/painful bladder syndrome (IC/PBS) / This study sponsored by Plethora Solutions will employ PSD597: 200 mg lidocaine (as 5 ml of 4% lidocaine solution) instilled into an empty bladder followed by 5 ml of 8.4% sodium bicarbonate (alkalinizing agent).

Local anesthetics such as lidocaine are increasingly recognized as having powerful broad-spectrum anti-inflammatory effects, including stabilizing mast cells and blocking histamine release. Theoretically they appear to be ideally suited to suppress the neuroinflammatory cycle occurring in IC/PBS.

Pharmacokinetic studies confirm that intravesical lidocaine is not sufficiently absorbed by human bladders to achieve a significant serum level or deep local anesthetic effect. Henry et al demonstrated in an animal model that the optimal absorption of intravesical lidocaine is achieved when bladder content pH is approximately 8.0 (an alkaline state), and further showed that similar effects could be achieved in normal and inflamed bladders. Therefore, intravesical alkalized lidocaine may offer a therapeutic approach to treat the pain and bladder inflammation associated with interstitial cystitis and painful bladder syndrome and may be useful to help differentiate the anatomical site of non-specific pelvic pain.

The study is being done to see if and how well the study medicine will work in IC/PBS. The study medicine will be compared with placebo in this study. If you qualify you may receive a physical exam and study medicine or placebo without cost to you.

For a study site near you that may not be listed call:
816-421-6400 ext. 2208

For more information about this study, please visit:
http://www.controlled-trials.com/ISRCTN56132730

University of Maryland Studies:
Dr. John Warren and his research team at the University of Maryland Interstitial Cystitis Center are currently recruiting patients for their two ongoing studies:

Events Preceding Interstitial Cystitis (EPIC)
Maryland Genetics Of Interstitial Cystitis (MaGIC)

To learn more about both of these studies please click on the link to the Interstitial Cystitis Center:

http://icresearch.umaryland.edu/

Interstitial Cystitis-A Study to Evaluate the Effectiveness of Acupuncture on Symptoms:
Principal Investigator: Larissa Rodríguez, MD
Co-Investigator(s): Shlomo Raz, MD

This trial is currently accepting new patient applications.

The objective of this study is to evaluate the effectiveness of acupuncture on symptoms of interstitial cystitis.

For more information including an online study application, please visit:

http://www.uclaurology.com/trials/Inter65.cfm

Genetic Study of Painful Bladder Syndrome:
At Children's Hospital Boston, the Harvard Urological Diseases Research Center is conducting a research study on the genetic causes of painful bladder syndrome, interstitial cystitis, and chronic pelvis pain syndrome (PBS/IC/CPPS).

Previous studies have suggested that painful bladder syndrome may be genetic and passed down (or inherited) from one generation to the next. Information gained from this study will help to improve the understanding of these conditions and lead to earlier diagnosis and better treatment.

Enrollment is voluntary, and there is no need to travel.

For more information please contact:

Elicia Estrella, MS, CGC
Children's Hospital, Boston
Program in Genomics
Enders 5
300 Longwood Ave.
Boston, MA 02115

Phone: (617) 919-4552
Fax: (617) 730-0253

Email: elicia.estrella@childrens.harvard.edu

From the ICA Mailroom:

I'm a "hardy old nurse" who can generally dig things out for myself, but the ICA is such a
valuable asset for getting a hold on the big picture and surely for those that don't have a medical background and aren't assertive; you are a GOD send. -CP

4. The Latest IC Research Highlights

Trigger Point Injections Can Help
Langford CF, Udvari Nagy S, Ghoniem GM. Levator ani trigger point injections: An underutilized treatment for chronic pelvic pain. Neurourol Urodyn. 2007;26(1):59-62.

This study included 18 women who had chronic pelvic pain for more than 6 months and had trigger points that a doctor or physical therapist could feel in the levator ani muscle during a vaginal examination. Physicians injected the trigger points injected with an anesthetic and steroid solution. (The solution is made up of 10 mL of 0.25% bupivacaine, 10 mL of 2% lidocaine and 1 mL or 40 mg of triamcinolone, and 5 mL of this solution is injected into a trigger point.) The women rated their pain and satisfaction with therapy. The bar for success was set fairly high, based on a 50 percent reduction in pain and a 60 percent improvement in satisfaction. After three months, 13 of the 18 women improved with the first injection, a success rate of 72 percent. Six (33 percent) of the women were completely pain free. These injections can be done in the office without sedation or anesthesia. To see where this muscle is, go to the "Peritoneum and Pelvic Floor" page of Stanford University's Lucy Project website (http://summit.stanford.edu/ourwork/PROJECTS/LUCY/lucywebsite/infofrperit.html).

Current Thinking on IC's Cause
Mayer R. Interstitial cystitis pathogenesis and treatment. Curr Opin Infect Dis. 2007 Feb;20(1):77-82.

We still don't know the cause of IC. In addition, it isn't the same in every patient and not all patients get relief from the same treatment, so there could be a number of causes. One of the latest ideas about what causes symptoms is that patients become hypersensitive to pain, pressure, or urinary urgency. How this process starts and keeps going and to what extent some kind of immune or nervous system dysfunction plays a role is being researched. The bladder lining is now known to secrete a number of signaling chemicals that may play a role. Research to help differentiate the types of IC will help so that treatments can target the different causes or processes.

RTX for Hard-to-Treat IC?
Peng CH, Kuo HC. Multiple intravesical instillations of low-dose resiniferatoxin in the treatment of refractory interstitial cystitis. Urol Int. 2007;78(1):78-81.

These Taiwanese urologists tried using low-dose resiniferatoxin (RTX) instillations to treat 13 patients (10 women and 3 men) with IC that didn't respond to other treatments. These patients had had IC for an average of 4.4 years and had tried other treatment for an average of about 15 months. The patients received the RTX instillations once a week for 4 weeks. One patient dropped out because the instillation was too painful. Among the other patients, two had an "excellent" result, five improved, and five had no change based on symptom, pain, and quality of life ratings. Bladder capacity or other urodynamic measurements did not change. The authors concluded that RTX instillations may be an effective therapy for IC. Studies of RTX in the United States, however, were stopped because it was not found to be effective. Some researchers think RTX may still have potential if it could be instilled in a solution that is not irritating itself.

Tibial Nerve Stimulation at Heel Eases Pelvic Pain
Kim SW, Paick JS, Ku JH. Percutaneous posterior tibial nerve stimulation in patients with chronic pelvic pain: a preliminary study. Urol Int. 2007;78(1):58-62.

The posterior tibial nerve runs down the leg to the foot and can be stimulated at the heel, where it comes close to the surface. This kind of stimulation is being tried for overactive bladder, pelvic pain, and IC symptoms. This preliminary study in Korea tested this kind of stimulation for chronic pelvic pain. It was tried in an open trial (no placebo treatment) in 10 women and 5 men with chronic pelvic pain. The 30-minute treatments were given weekly for 12 weeks. After 12 weeks, 9 patients (60 percent) had a greater than 50 percent improvement in pain, and 3 patients (30%) had a 25 to 50 percent improvement in pain. The average pain score when down from 8 on a 10-point scale to 4. There was no statistically significant improvement on the International Prostate Symptoms score or in frequency or bladder volume. This treatment, said the researchers, has potential for improving pain symptoms but longer follow-up studies are needed.

Future IBS Treatments May Be Targeted to Women
Ouyang A, Wrzos HF. Contribution of gender to pathophysiology and clinical presentation of IBS: should management be different in women? Am J Gastroenterol. 2006 Dec;101 Suppl 3:S602-9.

This review article in a journal for gastroenterologists should help these specialists understand that irritable bowel syndrome (IBS) patients often have other problems that need therapy, including IC. The article notes that IBS is more common in women than men and is more common in patients with many of the other problems IC patients often have, including chronic fatigue syndrome, fibromyalgia, and chronic pelvic pain. In this article, all syndromes were characterized by pain and found predominantly in women. Biological factors related to gender may explain this, and there are some differences in how men and women respond to treatment. New research, outlined in the article, may bring more gender-specific treatments in the future.

PBS Thought to be a Sensory Problem
Nordling J. Sensory bladder disorders. Int J Clin Pract Suppl. 2006 Dec;(151):38-42.

This researcher describes a number of bladder disorders as having their origin in abnormal sensations. He includes painful bladder syndrome (PBS) as one of these and believes that these patients should be categorized as having IC only if they show abnormalities in the bladder when it is examined cystoscopically or histologically. The article outlines the diagnosis, evaluation, and treatment of PBS.

Successful Pregnancy after Bladder Surgery
Shaikh A, Ahsan S, Zaidi Z. Pregnancy after augmentation cystoplasty. J Pak Med Assoc. 2006 Oct;56(10):465-7.

This case report from Pakistan documents a successful pregnancy and delivery by Caesarean section at 36 weeks in a 26-year-old woman who had bladder augmentation surgery for IC.

ICA Resources

We are very pleased to be able to introduce to you several brand new resources that are available exclusively through the ICA. With generous IC educational underwriting from the Medtronic Foundation, these resources were created by the ICA with care and compassion to address the specific needs of those who suffer from IC.

The Many Faces of IC—People Living with Interstitial Cystitis: Their Stories

The ICA has brought together a collection of some of our most popular and inspiring patient stories that we have had the privilege of publishing over the past several years.

This book contains 100-plus pages of inspirational and moving profiles of people living with IC. The Many Faces of IC includes portraits of men, women, and children from a multitude of cultural, ethnic, and philosophical backgrounds.

CLICK HERE TO ORDER NOW!

https://secure3.realssl.com/ichelp/store/shop.cgi?page=Topic10.html#BKMF06

Because You Care: Exploring the Unique Intimacy Issues of People with Interstitial Cystitis

Another first for the IC world from the ICA— a booklet about sexual intimacy issues and challenges written from the patient's perspective!

This one-of-a-kind booklet is written especially for people with IC and their intimate partners, offering insight into how IC affects sexuality, as well as successful coping strategies for achieving and maintaining rewarding intimate relationships while living with IC.

The 45-page Because You Care booklet focuses on the following challenges of sexual intimacy and IC: physical, psychological, emotional, social, spiritual, cultural, and other special concerns, such as medications and the concerns of men who suffer from IC.

CLICK HERE TO ORDER NOW!

https://secure3.realssl.com/ichelp/store/shop.cgi?page=Topic04.html#BKBYCI06

New Video Available!

IC: Current Concepts—Part Two of the ICA's Video Series

This video presentation was recorded at the ICA's University of Maryland Regional IC Forum that took place at the Hyatt Regency in Arlington, VA, in September 2005. The keynote speaker was 2003 National Book Award winner, Carlos Eire, PhD, a Yale University professor who is an IC sufferer. Featured presenters included clinicians and researchers from the University of Maryland: Toby Chai, MD; Susan Keay, MD, PhD; and John Warren, MD. ICA Founder and President, Vicki Ratner, MD, moderated the event.

The most current IC research is explained by the researchers themselves. IC: Current Concepts is designed for both IC patients and healthcare providers. The presentation is available in both DVD and VHS formats.

CLICK HERE TO ORDER NOW!

https://secure3.realssl.com/ichelp/store/shop.cgi?page=Topic09.html#UM05

ALSO AVAILABLE: For those of you who prefer reading IC presentations, we have published a written transcript of IC: Current Concepts.

CLICK HERE TO ORDER NOW!

https://secure3.realssl.com/ichelp/store/shop.cgi?page=Topic01.html#TRUM05

Our Pocket Guide Series Continues!

IC: Expert Opinions, Volume II

With IC: Expert Opinions, Volume II, we have assembled some of the top experts in the field of IC to explore specific topics and special concerns that people with IC often ask about. This is the fourth addition to our Pocket Guide series. Physicians included in Expert Opinions, Volume II: Robert Evans, MD; Christopher Payne, MD; Susan Keay, MD; John Warren, MD; and Kristene Whitmore, MD.

CLICK HERE TO ORDER NOW!

https://secure3.realssl.com/ichelp/store/shop.cgi?page=Topic01.html#XOP205

5. Upcoming Conferences

American Academy of Pain Medicine 23rd Annual Meeting
February 7-10, 2007
Ernest N. Morial Convention Center
New Orleans, LA
http://www.painmed.org/annualmeeting/

SUNA 2007 ANNUAL SYMPOSIUM: Disorders of the Bladder, Bowel and Pelvic Floor
March 15-17, 2007
The Broadmoor
Colorado Springs, CO
This conference, focusing on sexuality and sexual dysfunction, will offer a variety of topics and outstanding speakers, from basic workshops to advanced practice content, all offering current evidence-based information.

For more information or to submit an abstract, visit SUNA's website at http://www.suna.org/ or call toll free 1-888-TAP-SUNA.

The 26th Annual Scientific Meeting of the American Pain Society
May 2-5, 2007
Washington Convention Center
Washington, DC
http://www.ampainsoc.org/meeting/

American College of Obstetricians and Gynecologists 55th Annual Clinical Meeting
May 5-9, 2007
San Diego Convention Center
San Diego, CA
http://www.acog.org/acm/

American Urological Association 2007 Annual Meeting
May 19-24, 2007
Anaheim, CA
http://www.aua2007.org/

International Continence Society Annual Meeting
August 20 - 24, 2007
Rotterdam, Netherlands
http://www.icsoffice.org/ASPNET_Membership/Membership/Events/ViewEvent.aspx?EventID=45

6. Products That Can Help YOU Today!

Cysta-Q: Farr Labs, LLC, has developed two special formulas that are specifically designed for IC patients and nonbacterial prostatitis patients:

Cysta-Q and Prosta-Q. Cysta-Q is a dietary supplement that targets the urinary frequency, urgency, and pain of IC. Cysta-Q consists of a patent-pending extracted blend of the following ingredients—quercetin, bromelain, papain, cranberry powder (non-acidic), black cohosh (non-acidic), skullcap, wood betony, passionflower, and valerian. Farr Labs also distributes Prosta-Q, an over-the-counter quercetin dietary supplement that promotes and maintains prostate health.

Published research of clinical trials has shown that both Cysta-Q and Prosta-Q significantly reduce symptoms of IC and chronic pelvic pain syndrome in men.

To find out more visit http://www.cystaq.com/ or call (877) 284-3976.

For more information about Prelief, please visit http://www.prelief.com/ or call (800) 994-4711.

Desert Harvest makes this very concentrated form of aloe vera just for IC patients. They remove the two chemicals in the aloe plant that cause diarrhea, and all of the water and fiber, leaving all of the other ingredients of the plant intact. Desert Harvest dries their aloe without heat. Heat can damage the active ingredients, and adds no fillers or preservatives.

For more information and a free sample, please visit http://www.desertharvest.com/ or call 1-800-222-3901.

For more information, please visit http://www.teeccino.com/

For more information, please visit http://www.new-pattern.com/ or email bonange@cox.net

please visit http://www.bomasense.com/ or call 301.231.3300.

To find out more please visit http://www.minutemaid.com/.

To find out more, please click here.