CAFÉ ICA, VOLUME 7, NUMBER 2, February 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 IC Patients Voice Concerns in a Global Name Change Survey
1.2 ICA Founder and President Thanks Survey Participants
1.3 MediciNova Announces Results From a Phase II/III Interstitial Cystitis Trial With MN-001
1.4 Houston IC Group Announces Annual Conference

2. Voices in the IC Community
2.1 ICA Goes to New Orleans to Educate Pain Management Physicians
2.2 What's in a Name?

3. News YOU Can Use!
3.1 New Web-based Study to Focus on CAM
3.2 Current Clinical Trials Seeking Participants
3.3 ICA Call to Action!

4. The Latest IC Research Highlights

5. Upcoming Conferences

6. Products That Can Help YOU Today!

From the ICA Mailroom:

I have the full faith in the ICA. I am very honored to be a member. Without the ICA we all would be up the creek without a boat. - Ken

1. Hot Off the Press

1.1 IC Patients Voice Concerns in a Global Name Change Survey

In an important Internet survey of the global interstitial cystitis/painful bladder syndrome (IC/PBS) community, 2,347 individuals who received an email invitation to complete the survey spoke their minds, and demanded that their voices be heard and taken seriously.

The survey was developed by Michael Chancellor, MD, Professor of Urology at the University of Pittsburgh School of Medicine and Director of the Fishbein Family Foundation CURE-IC Program.

The purpose of the survey was to seek the opinions of people with IC in the IC/PBS community internationally regarding a possible name change of the condition. This survey was precipitated by the actions of a small group of urology researchers who have indicated that the term IC or IC/PBS should be changed to Bladder Pain Syndrome (BPS).

Dr. Chancellor felt that the IC patient community should have a voice in this matter, so the Fishbein Family CURE-IC program developed a simple Internet survey that was distributed through various global IC/PBS databases. The survey was open from January 23 to February 1, 2007.

2,347 persons from around the world responded. An overwhelming majority of survey participants did not agree with the proposed name change. 2,187 (93.2%) did not feel that there was a compelling reason to change the name at this time, while 160 respondents (6.8%) felt that the name should be changed to BPS.

In addition, 97.8% of responders indicated that they should have a voice in this decision process. A total of 4,193 comments were submitted.

1.2 ICA Founder and President Thanks Survey Participants

Thank you very much for your participation in Dr. Michael Chancellor's survey regarding the proposed name change for interstitial cystitis (IC)! The Interstitial Cystitis Association (ICA) sent out more than 12,000 survey emails to interested parties and, within one week, we received an overwhelming response from almost 2,400, which is a response rate of about 20%.

For obvious reasons, the name change issue is of concern to every individual with IC, their families, and loved ones. As you may know, given the 23 years that the ICA has spent putting IC "on the map" as a disease, we fear a name change at this time would set back the progress we've made in IC awareness, diagnosis, treatment, and research funding.

Of the nearly 2,400 responses received from the survey, 93% were against the name change for many specific reasons, and 98% said that the IC patient community should have a voice in the discussion. Additionally, almost every respondent who referenced "urgency" in his or her comments noted how significant this symptom is for them and how it must be retained in the diagnosis of the illness.

In mid-February I traveled to Washington, D. C. for a special conference where a key agenda item was discussion of the prospective name change for IC. While there, I met with many medical professionals including IC clinical specialists and researchers. In addition, I spoke with representatives who came all the way from Europe.

Your views - the views of the IC patient community - were shared with all attendees. The fact that such a conference was held is due to the advocacy efforts of the ICA over the past year, during which we spent countless hours contacting medical doctors and researchers to alert them to the prospective name change for IC, obtaining their schedules for a conference, and sharing with them the impact a name change would have on the diagnosis and treatment of the many who suffer so greatly from this illness. The conference was funded through a generous grant from Ortho Women's Health and Urology, which is being shared by the ICA and the Association of Reproductive Health Professionals (ARHP), with whom we are working in partnership on the project.

This meeting was significant because it gave medical professionals a much needed opportunity to discuss issues surrounding the name change and definition of IC. Next steps for the ICA and ARHP will be cooperative projects that include the compilation of an IC-related curriculum for medical training, along with revised standards for IC diagnosis and treatment. The ICA plans to have representatives available at every opportunity to discuss these ideas, and we will be sharing the results with all of you.

Again, I want to thank you for your participation in this very important survey, and for your ongoing support of the ICA. As you know, our mission is to provide public awareness of IC, patient services to individuals with IC, and research to discover treatments and, ultimately, a cure for this debilitating illness. I sincerely believe that the future quality of life for those who suffer from IC is, in large part, dependent upon the continued success of the ICA in accomplishing its mission. Of course, your financial support of our efforts is greatly appreciated.

Warmest regards,

Vicki Ratner, MD
ICA Founder and President

Please note this link, www.ICHELP.org, where you can read about IC, IC treatments, our sponsors, and (should you like) make a donation to our annual fund to help our programs of public awareness, patient services, and IC-related research. Thank you!

1.3 MediciNova Announces Results From a Phase II/III Interstitial Cystitis Trial With MN-001

SAN DIEGO, Jan 16, 2007 (PrimeNewswire via COMTEX News Network) -- MediciNova, Inc., a biopharmaceutical company that is publicly traded on NASDAQ (Trading Symbol: MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number: 4875), today announced the results from its Phase II/III randomized, double-blind, placebo-controlled clinical trial of MN-001 in 305 patients with moderate-to-severe interstitial cystitis (IC). While MN-001 was well-tolerated, MN-001 did not show a statistically significant clinical benefit compared to placebo on the primary endpoint (to be much or very much improved overall on a patient-rated Global Response Assessment) at the doses tested in this trial (500mg once or twice a day for 8 weeks). Results from this Phase II/III trial indicated that IC patients were more than twice as likely to respond on 500 mg of MN-001 administered twice a day compared to placebo (25% compared to 12%, p=0.04) after 4 weeks of treatment. This difference, however, was not observed at 8 weeks due to continued improvement among placebo-treated patients. The response rate of patients treated with 500 mg of MN-001 once a day did not significantly differ from placebo at either 4 or 8 weeks.

"Although we are disappointed that MN-001 did not demonstrate a statistically significant improvement in IC symptoms, we believe that the compound warrants continued development, especially in bronchial asthma where positive clinical trial results have been observed at higher doses," said Yuichi Iwaki, M.D., Ph.D., Executive Chairman and CEO of MediciNova, Inc. "In our Phase II asthma trial, a statistically significant improvement in mean FEV1 (forced expiratory volume in 1 second) was observed after 4 weeks of treatment with 500 mg MN-001 three times a day compared to placebo (p=0.021; intent-to-treat, observed cases). A similar trend was observed for the 750 mg twice a day dose (p=0.058). We plan further analysis of the data from our clinical trial in IC with the goal of reevaluating our clinical strategy and determining the future of this program. We also anticipate important milestones throughout the year in our other clinical programs which are progressing well."

1.4 Houston IC Group Announces Annual Conference

Cindy Sinclair, President of Interstitial Cystitis United (ICU), the patient-led consortium of IC support groups in Houston, Texas, recently announced the group's 2007 Chronic Pelvic Pain Patient Education Day Conference:

Saturday, April 21, 2007
8:30 a.m. to 3:30 p.m.
(Registration 7:30 - 8:30 a.m.)

Hotel Derek
(610 West Loop & Westheimer)
2525 West Loop South
Houston, TX 77027

Keynote Speaker:
DANIEL BROOKOFF, MD, PhD
Center for Medical Pain Management Presbyterian/St. Luke's Medical Center, Denver, CO
Topic: "Managing Chronic Pelvic Pain Conditions"

Guest Speakers:
HELEN DEARMAN
Founder & Executive Director National Chronic Pain Society
Topic: "Pain & Suffering: Is There a Difference?"

CHRISTOPHER JAYNE, MD
Director, Center for Women's Sexual Health, Houston, TX
Topic: "Managing Female Sexual Dysfunction"

RACHEL WINER, PHD
Clinical Psychologist, Houston, TX
Topic: "Improving Patient/Doctor Relationship"

For more information including registration information, please click here:
http://www.icutexas.com/conference_2007.html

From the ICA Mailroom:

I'm so grateful for the support you've shown me--a total stranger. It really helps to know that I'm not imagining the intensity of the pain. -M

2. Voices in the IC Community

2.1 ICA Goes to New Orleans to Educate Pain Management Physicians

New Orleans is a city struggling to reach out to visitors but does it enthusiastically and works hard to grow their numbers. That was the perfect metaphor for the ICA's outreach to physicians at the American Academy of Pain Management (AAPM) meeting in the Crescent City in February.

Fulfillment Coordinator Carolyn Coogan and National Patient Advocate Linda Salin didn't have as many physicians to talk to as they would have had during the city's more bustling convention times. But the information they gave to pain management physicians there helped educate those unfamiliar with IC, gave those who did know something about IC the tools to be more effective, and put sympathetic and enthusiastic physicians on our referral list. In fact, AAPM President B. Todd Sitzman, MD, made a point of introducing himself to Linda and asked the ICA to be a liaison between his office and people with IC.

"The pain management doctors we talked to felt really sorry for people who can't get appropriate pain management and understood it was a terrible problem and a real crisis facing the country," Linda said.

Carolyn pointed out that pain management as a specialty really didn't exist before about 1980, and doctors in this specialty are still learning about IC. She was in terrible pain herself at that time and had great difficulty finding a physician who was savvy about treating chronic pain and nerve pain.

Since then, pain management as a specialty has grown, and urologists and other physicians who diagnose IC often don't have pain management expertise and have begun referring IC patients to these specialists. "Now, more pain management doctors are getting these patients. Obviously, these doctors have to learn about the condition, so we need to educate them," said Carolyn.

From some pain management physicians, Carolyn heard the same things that she heard from urologists years ago-that it's difficult to help IC patients and how frustrated these physicians were. She and Linda gave these doctors ICA-developed resources targeted to them-information about combination treatments, about follow-up with physical therapy, about opioid management, and more.

Some physicians eager to learn much more about treating IC and snapped up the ICA's book, IC & Pain: Taking Control; issues of our newsletter for health professionals, ICA Professional Perspectives; and copies of Robert Moldwin, MD's lecture from the ICA's Long Island Regional IC Forum.

"It was positive to see that the doctors we gave more information to were really grateful for it," said Carolyn. "They were hungry for it. Some of them are the only pain management doctor for miles. They get a lot of the IC patients, and unfortunately, they are not knowledgeable enough about available treatments. I love to see that interest. You always feel really good when you come back from the meeting and you've really reached some doctors."

The ICA is dedicated to continuing outreach to all areas of the medical community in 2007 and beyond.

2.2 What's in a Name?

What's in a name? Apparently quite a lot if you ask people with IC! Dr. Michael Chancellor's survey, which was conducted via the Internet recently to find out if people with IC want to see the name of interstitial cystitis changed and if they feel that the patient community has the right to a voice in the decision-making process (see articles 1.1 and 1.2 above), evoked such an incredible outpouring of very thoughtful and insightful comments that we wanted to be able to share at least a sample of them with you. While it would be impossible to post all responses here, below is short sampling of responses to the four categories in which people voiced their opinions. We selected these randomly and apologize if your opinion is not represented. We thank each and every one of you who took the time to share your thoughts and let your voices be heard.

Random examples of the majority opinion - those not in favor of the recently proposed name change:

- For many years, IC sufferers & organizations such as the ICA have been fighting to get information out to doctors & to the public, to let them know what IC is & how people are affected by it. Now I am starting to see many more magazine articles about IC or that mention IC. If the name is changed now, it will be just like starting all over. Doctors, employers, friends & family will have to be educated all over again.

- Interstitial cystitis has become well known by that name and a change such as proposed is too broad and will be a setback for patients with IC in terms of diagnosis and treatment. IC patients who are diagnosed and those who are not diagnosed will be mixed in with several other bladder problems such as spasmodic bladder, cystitis, etc. To eliminate "urgency" as a symptom so typical of IC would do a great injustice to new patients not yet diagnosed. I hope that 20 years of public awareness and the knowledge of IC as a specific disease by urologists, internists, etc., is not set back by this new terminology.

- I agree with all the points you made in why to NOT change to painful bladder syndrome. I DO hope the European community will see how important IC is to us for SSA and medical coding . . . AND, I just learned something new (to me) from you: One can have urgency without a requirement of being concerned with not reaching the bathroom in time. Of course! It's the pain that makes ME feel urgent about finding a bathroom. I'm fortunate that I can wait when needed. So, in this way, I do have urgency.

- I'm a nurse and I think interstitial cystitis is a mouthful. But, bladder pain syndrome doesn't sound serious enough to explain what is wrong with my bladder. A simple bladder infection could be explained by this name, the symptom would be the same, a very painful bladder. To exclude urgency would be to totally negate one of my constant symptoms when flared-up. I agree that urgency may not exactly explain this IC symptom, but it is a big, life- altering symptom that I have lived with on and off for most of my life and to exclude it would make my disease even harder to explain to others. I understand IC is hard to say and hard for the general public to understand, but that is preferable to the more casual title of bladder pain syndrome. It seems one more way that men are trying to negate the pain and suffering I have been through for years. We have suffered ignorance and lack of belief about our symptoms and that there even was disease from family and even from professionals. Most people with IC have been ignored and thought crazy by physicians for a long time now, it usually takes multiple visits to many doctors to finally get a correct diagnosis of this terrible disorder. Now is not the time to make light of this disease that has caused such life altering discomfort and pain.

- The name is accurate as it is. People are just learning what it is. The new name seems to resemble irritable bowel syndrome that is not taken as seriously as say, colitis. There is as big difference between them as is IC and a bladder syndrome. Perhaps that is a different condition altogether. I wouldn't want people to lose disability or medical help because of a name change. It concerns me.

- As an IC patient that was diagnosed in 1992 when much wasn't known about IC and it took a number of years to finally get the correct diagnosis, this will happen again if the name is changed and all the years of work, research and funding would be in jeopardy. Why fix something that isn't broken?

- Frequency and urgency are my primary symptoms and they impact my life tremendously. Since the medical field is already familiar with these symptoms, it would be a great disservice with patients having these problems, not to be recognized.

- I am afraid that if the name is changed it will have a negative impact on patient care. I live in Tennessee and the doctors here are not educated enough as it is about IC. If the name changes to something that broad, I feel that doctors will for sure not take IC seriously. IC is very painful but urgency and frequency also go along with IC and these symptoms need to stay intact as part of the diagnosis.

- If the new name more appropriately described what we have I would be in favor of it. But the new name proposed does not. It seems much too broad to me.

- The medical profession took a long time to grasp the concept of IC (some are not there yet); reeducating the "rank and file" will prove difficult at best. Most of us have experienced the non-believing physicians; that is, if they don't know or understand, then the patient needs psychiatric help. Do we really want to negate all the progress that has been made? I cannot see that starting fresh with a new name helps anyone, least of all the patients.

- I feel that changing the name will confuse physicians and patients alike. Urgency was one of the first problems I experienced with IC. I would ask that this be reconsidered.
I have SEVERE IC -- but pain is the least problematic of my problems. For me it is URGENCY and frequency (along with difficulty). To rename it about being a painful bladder isn't accurate -- and to remove a key symptom makes no sense. We are just beginning to have a better understanding of this horrible condition -- and getting those who don't suffer to recognize this as a true disabling condition. I think a name change would be taking a backwards step -- one we don't need.

Random examples of the minority opinion - those in favor of the recently proposed name change:

- Bladder pain syndrome more accurately describes what it is like to have IC. Also this name change would distinguish patients who suffer from this chronic condition from patients who simply have the occasional UTI, known as cystitis.

- It has been my experience that people, including most medical professionals generally only "hear" the word "cystitis" when I mention my condition and associate my symptoms with ordinary cystitis.

- The term "interstitial cystitis" is so difficult for anyone to understand when you're describing your problem. They always say, "What?" Perhaps a name more descriptive of the pain and near total disability IC causes would help others understand the seriousness of the disorder.

- The words currently in use are too difficult to pronounce, people have no idea what you are talking about and it becomes confused with bacterial cystitis. I would like a name change, but I am in no position to decide what that would be.

- The cystitis part is misleading. It's also cumbersome. I like the name bladder pain syndrome because it is so straightforward but I understand the diagnostic and other concerns.

- I think the ordinary person can relate much better to a simpler name such as painful bladder syndrome.

- For me, that is what it is and is really the best way to describe it. Syndrome implies a collections of symptoms, manifestations, whereas most people who hear the term interstitial cystitis - if they have even heard of it, think you just have a uti.

- I think IC is very difficult for people to understand what it means. I am a RN, and even in the healthcare field, no one knows what IC is, or can figure it out by the name, and I continually am explaining what it is. While I feel that education about this condition is very important, I think the name is unrecognizable. But, I think that if a name change is decided, then you should use both names together for a period of time (ie: 3 years) so that for the people who know the condition as IC- then it can be recognized as PBS.

Random examples of the majority opinion - those who feel that the patient community should have a voice in the decision-making process:

- If you don't have IC you cannot understand. We have suffered with misdiagnosis and treatments before knowing what we really had.

- Definitely, by all means. Who better to make these types of decisions than those of us who live it every day of our lives and know the pain and frustration and complications of this disease not only on a daily basis, but hourly, if not minute by minute. "IC" needs to become a "household" word with every person involved in the medical industry. It should resonate throughout our Government, Media, Public Officials, etc., until everyone associated in the medical profession not only knows of IC, but is "familiar" with it, its
symptoms, and debilitating effects throughout the entire body.

- Because our care is at stake.

- Simply: we can pay for the ill-advised decisions of others in terms of losing benefits, the loss of clarity in the identification and diagnosis of our disease, and the confusion of its symptoms with lesser defined conditions.

- Any potential change in name affects the IC patient community if, by personal experience, is it is deceptive or inaccurate. The change in name could also affect accessibility to funding or, change the manner in which existing funding is used.

- We know the impact and the symptoms of the disease better than anyone else.

- IC affects every part of my day. Driving, working, social time, and my person relationship are impacted by my pain caused by IC. We need to have our voices heard directly.

- Getting the word out about IC is very important to us.

- They are the ones that could be affected if the name change and definition change results in confusion with the medical community, with insurers, employers, and the social security administration.

- It's our disease.

- I am 22 years old and will live with this condition for the rest of my life. If that doesn't entitle me to a valuable opinion, I don't know what does.

- Patients with IC live with mild, moderate and severe pain of the bladder lining, but the emotional suffering that the majority of us have gone through due to ignorance of the disease by professionals has been traumatic. This ignorance continues to this day! Let's not pretend that the small strides to educate physicians and other medical professionals are finished-----we still have a long way to go! Yes, the IC community should voice, strongly and loudly, our opinion about making any kind of change. I'd like to
see the research on making a symptom diagnostic change. Where is the research?? In the scientific community, research is needed to make changes, is this not how it works in Europe?

- As sufferers of this disease, we are the people whose lives are most affected. We live with the pain, we go to the many physicians appointments, bear the burden of the cost of medications, surgeries, tests.

- For many of us, our lives are changed forever by this disease. We suffer, our families suffer, our friendships suffer. We deserve to be the ones to make the decision whose consequences we will have to live with. No one else will be as deeply affected by this decision. Decision makers can leave their offices and leave this issue behind while they go home to their lives. IC sufferers cannot. It is unimaginable that the IC community would not be included in any change that affects so many people so deeply.

The IC patient community has been the main force and power behind any of the research, laws passed, and making the name familiar to the medical community. Where would we be now if the patient community had not been organized years ago?

- The patients know themselves and their illness intimately and can ultimately be the best advocates for themselves.

- As the ones afflicted with this horrible, life-altering condition-- we should be the ones to voice our opinion if a change is made. This could alter awareness in the medical community and possibly pose a problem in the disability process for those unable to control their IC through medication and lifestyle changes.

Random examples of the minority opinion - those who feel that the patient community should not have a voice in the decision-making process:

- I think having the disease doesn't give me the right to choose. But I think it's nice that you are asking. Thanks for your sensitivity. Name it what you like just keep helping us by informing the doctors and the public of it's existence. And thank you for all you do.

- I say "no" reluctantly and as a health professional. If we left condition names up to patients it would be a mess. However, if by "IC patient community" you mean IC patient advocates and professionals dealing with IC patients, then my answer would be "yes."

- What the people of the head of this want to do usually do, they may read what the people want but in the end they will do what they want.

- Whilst I appreciate that people who have this problem (and I am one of them) have a vested interest in the identification and development of a cure, the medical vocabulary associated with this and other ailments is in the realm of medical professionals who have deep levels of expertise in fields of science and anatomy and are thus better equipped to decide the vernacular.

- I will trust that professionals familiar with IC can make a sound decision on this.

- I do not believe patients such as me are qualified to determine if there should be a name change.

- Just because we have the disease does not give us the right to be included in the body of persons who determine the name. When Darwin named species that he found in the Galapagos, he didn't ask the crew to come up with a name for each. Instead, he picked a name that was as descriptive of the species as he could, in the then language of science, Latin. If most urologists agree that the most descriptive name they can give a set of urological symptoms happens to be IC, then those that happen to have it should not be
able to vote to have it named "Damn hurtful bladder" disease.

- It's up to doctors to name medical conditions. It's a non-issue for me. Who cares what it's called?

- A disease should not be named or have its name retained based on the opinions of those it effects. Diseases should be named, and names changed, as the diagnostic criteria becomes more (not less) specific. As non-medical people we should allow the medical community to use the most specific labels they can find to communicate with each other about the condition. This only benefits the patient.

3. News YOU Can Use!

3.1 New Web-based Study to Focus on CAM

An exciting new complementary and alternative therapies research project is being conducted by faculty at the UCLA Schools of Public Health and Medicine. PROCAIM, which stands for People-Reported Outcomes from Complementary, Alternative, and Integrative Medicine, was developed under a grant from the National Center for Complementary and Alternative Medicine (NCCAM) to enable large-scale research on (1) the effectiveness of the full range of mind/body medical interventions and other complementary and alternative therapies, and (2) the interactions among stress, pain, and responses to the various available treatments.

PROCAIM will collect a wide range of information directly from patients using standardized questionnaires that address changes over time in symptom severity, spirituality, optimism/pessimism, mood, stress and coping skills, and quality of life. It will also serve as an information resource for patients and participants in health-enhancement activities.

Because it is web-based, patients may enroll on-line, provide informed consent, and answer a series of questionnaires at intervals for one year. Clinics and individual treatment providers can join PROCAIM to help track their patients' outcomes. Clinical researchers can utilize any of the questionnaires in PROCAIM's survey library and its Internet accessibility to collect longitudinal data from patients in clinical trials or to conduct health outcomes studies. Other researchers can use PROCAIM's database and questionnaires to address specific hypotheses, add other instruments, and develop and test new questionnaires.

The resulting PROCAIM Network is a multi-site research project linking patients, treatment providers, and researchers interested in improving health and well-being through the various integrative therapies, including mind/body approaches and complementary and alternative medicine.

By making PROCAIM widely available, the study researchers hope to obtain high quality observational data from large numbers of current users of complementary and alternative medicine - especially those with functional and stress-related conditions - including their demographic and clinical characteristics, utilization of and satisfaction with the care, as well as their responses to treatment. The researchers are encouraging the enrollment of people with IC, fibromyalgia, IBS and other chronic recurring conditions.

For more information including enrollment instructions, please click here:
www.procaim.org

3.2 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 have 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:

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 Study:
Dr. John Warren and his research team at the University of Maryland Interstitial Cystitis Center are currently recruiting patients for their study:

Maryland Genetics Of Interstitial Cystitis (MaGIC)

To learn more about this study 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 pelvic 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

3.3 ICA Call to Action!

A Message from the Society for Women's Health Research:

Support the Women's Health Office Act by Signing Our Petition to Congress

What is the Issue and Why Should I Care?
Women's health research is in jeopardy and your support is needed to ensure its future! Special offices in the federal government dedicated to improving the health of all women are operating on shaky ground. At any moment, their funding could be cut or they could be forced to close their doors.

The Society for Women's Health Research (SWHR) is working with Congress to see that this does not happen and women's health remains a top priority. A bill called the Women's Health Office Act (WHOA) was just reintroduced in the U.S. House of Representatives and in the Senate. If made law, it would protect the offices and provide them with statutory authorization.

View H.R. 1072
View S. 612

SWHR is doing everything in its power to guarantee that women's health research has a bright future. By joining forces with SWHR in support of WHOA, you too can help see that a positive change is on the horizon for the health of all women!

What Can I Do to Make a Difference?

You can do this by signing our online petition. The petition will be sent by SWHR on your behalf to the people who represent you in Congress. Click here to read the petition letter we will send for you. You may also choose to download the letter and send it on your own. To find out who represents you in Congress (one House member and two Senators) and their mailing addresses, visit
http://www.yourcongress.com/MemberSearch.asp and enter your nine digit zip code. Sign today at this link:
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From the ICA Mailroom:

My mind and heart have been so frustrated with this not knowing where to turn, I appreciate your help. I will definitely be calling to make a donation, today! I would be lost without this resource. -KSK

4. The Latest IC Research Highlights

What Is Urgency in IC? EPIC Study Answers the Question
Diggs C, Meyer WA, Langenberg P, Greenberg P, Horne L, Warren JW. Assessing Urgency in Interstitial Cystitis/Painful Bladder Syndrome. Urology. 2007 Jan 30; [Epub ahead of print]

The University of Maryland Events Preceding IC (EPIC) study is getting a handle on what the experience of early (in the first year) IC/Painful Bladder Syndrome (PBS) is like and will help create a working definition of IC. Lately, IC experts have been debating what "urgency" is and whether IC patients have it. This study showed that IC patients do indeed have it, but it depends on what you call urgency. The most common questionnaire used to assess IC symptoms is the Interstitial Cystitis Symptom Index (ICSI), also known as the O'Leary-Sant Symptom Index. It looks at four major symptoms of IC/PBS-bladder pain, urgency, frequency, and nocturia-and asks how often you experience them. The EPIC researchers used this questionnaire and another set of questions about symptoms and severity and compared the answers. In 138 women, the ICSI scores and the other questions correlated well when it came to frequency and pain, but not to urgency. The ICSI questionnaire asks about "the strong need to urinate with little or no warning," whereas a question about severity asks about "the compelling urge to urinate that is difficult to postpone." Some patients say no to the first question about whether they have urgency and yet report intense urgency in response to the other question. So, concluded the researchers, the ICSI underestimates the prevalence and degree of urgency in IC/PBS. That squares with the opinion of some experts that sudden urgency really doesn't describe what IC/PBS patients feel. Getting clear on this point will help researchers develop a good working definition of IC/PBS, the authors said.

Symptoms Distinguish IC from Other Conditions
Bogart LM, Berry SH, Clemens JQ. Symptoms of interstitial cystitis, painful bladder syndrome and similar diseases in women: a systematic review. J Urol. 2007 Feb;177(2):450-6.

Symptoms of IC overlap with many other conditions, including painful bladder syndrome, urinary tract infection, vulvodynia, endometriosis, overactive bladder, and "chronic urethral syndrome." These researchers combed through the medical literature (looking at more than 2,000 articles) to see if IC could be distinguished from these other problems based on the symptoms, which would give physicians a good case definition-a kind of working definition-of IC. The most common symptoms reported in IC were bladder/pelvic pain, urgency, frequency and nocturia and that IC and painful bladder syndrome (PBS) have the same group of symptoms, so they may be the same thing, the researchers said. For the most part, UTIs can be distinguished from IC and PBS by patients' reports of symptoms and the effectiveness of antibiotics, although urine cultures may also be needed to pin that down. Pain distinguishes IC from overactive bladder, and vulvar pain may distinguish vulvodynia from IC. Painful menstruation distinguishes endometriosis from IC, although many women have both. Chronic urethral syndrome is an outdated term, the investigators said.

Family Physicians Get Realistic Picture of Chronic Pelvic Pain and IC
Bordman R, Jackson B. Below the belt: approach to chronic pelvic pain. Can Fam Physician. 2006 Dec;52(12):1556-62.

These family medicine physicians gave their colleagues a picture of pelvic pain and its treatment, emphasizing that IC is one of the top four sources of chronic pelvic pain along with endometriosis, adhesions, and irritable bowel syndrome. The sources can be gynecologic, urologic, gastrointestinal, musculoskeletal, or psychoneurologic. The authors also stressed that patients often have more than one source of pain. The definition they spelled out for chronic pelvic pain-nonmenstrual pain lasting six months or more that is severe enough to cause functional disability or require medical or surgical treatment-emphasizes to family physicians how disabling and severe the problem can be. Management of the pain, the authors said, involves treating the underlying condition, the pain itself, or both. They said that a multidisciplinary approach addressing environmental factors and incorporating medical management with physiotherapy, psychotherapy, and dietary modifications works best. They also noted that nonnarcotic analgesics are first-line therapy for pain relief and that hormonal therapies are beneficial if the pain has a cyclical component. Family physicians, the authors concluded, are in an ideal position to manage and coordinate the care of chronic pelvic pain patients.

Role of Pelvic Floor Dysfunction in Pain, Sexual Problems Points to Physical Therapy Potential
Rosenbaum TY. Pelvic floor involvement in male and female sexual dysfunction and the role of pelvic floor rehabilitation in treatment: a literature review. J Sex Med. 2007 Jan;4(1):4-13.

This review article emphasizes the importance of pelvic floor dysfunction in continence, sexual function, pelvic pain, and lower urinary tract symptoms. It correctly identifies too-tight muscles as a source of sexual pain and notes that conditions such as pelvic pain and urinary tract symptoms are related to sexual dysfunction. Pelvic floor rehabilitation has great potential in treatment, but further research validating physical therapy as a treatment is needed, the authors said.

APF, HB-EGF Change after Hydrodistention, But Don't Predict Response
Erickson DR, Kunselman AR, Bentley CM, Peters KM, Rovner ES, Demers LM, Wheeler MA, Keay SK. Changes in urine markers and symptoms after bladder distention for interstitial cystitis. J Urol. 2007 Feb;177(2):556-60.

New IC patients (33) who had never had any IC treatment had urine markers measured and underwent hydrodistention. One month later, levels of antiproliferative factor (APF) and heparin-binding epidermal growth factor-like growth factor (HB-EGF) had changed significantly. Only a quarter to a third of patients had their symptoms improve, however, and the marker levels didn't predict who would benefit and who wouldn't. It still isn't clear, the authors said, why hydrodistention helps some patients.

Drug in Development for IC Inhibits Inflammation
Boucher W, Kempuraj D, Cao J, Papaliodis D, Theoharides TC. Intravesical suplatast tosilate (IPD-1151T) inhibits experimental bladder inflammation. J Urol. 2007 Mar;177(3):1186-90.

The experimental drug suplatast tosilate (IPD-1151T) is a compound that is in clinical trials for IC. It seems to regulate immune system processes, but how it works isn't entirely clear. These researchers did basic research to look at how this drug changed levels of two inflammatory and immune system chemicals, histamine and tumor necrosis factor (TNF) in the urine and in bladder tissue when the bladder was in a normal state or irritated with carbachol or lipopolysaccharide to help simulate IC. Suplatast tosilate inhibited carbachol-induced histamine release into the urine by 77%. It also inhibited the lipopolysaccharide-induced TNF release by 95% in five of nine bladder tissue preparations. The drug did not change skin permeability or activation of mast cells themselves. That showed, concluded the researchers, that the drug inhibits histamine and TNF release that doesn't involve inhibiting mast cells directly. The results point to a beneficial effect in IC, the authors said.

Small Study Finds No IC Benefit with Duloxetine
van Ophoven A, Hertle L. The dual serotonin and noradrenaline reuptake inhibitor duloxetine for the treatment of interstitial cystitis: results of an observational study. J Urol. 2007 Feb;177(2):552-5.

Duloxetine is an antidepressant that has FDA approval for major depression and for peripheral neuropathic pain in diabetes. A major reason it is tried in IC is because some IC pain is thought to be from damaged or dysfunctional nerves. In this uncontrolled (no comparison group) study, 48 women with IC took duloxetine (Cymbalta) for two months, starting with a low dose and working up to 40 mg twice a day. Patients were asked about their general well being, any changes in pain and urgency and overall symptom severity, and changes in frequency and functional bladder capacity based on a 48-hour voiding diary. Of the 48 patients, 17 (35%) dropped out of the study because of nausea. (In clinical trials, about 20% of patients had nausea.) Five (10%) patients responded, and needed to get up to the target dose to have the response. These urologists said they couldn't recommend duloxetine as IC therapy.

Brain Processing May Explain Related Pains
Fenton BW. Limbic associated pelvic pain: A hypothesis to explain the diagnostic relationships and features of patients with chronic pelvic pain. Med Hypotheses. 2007 Feb 8; [Epub ahead of print]

Increasingly, researchers are finding that pain is processed in structures in the brain known as the "limbic system." This author thinks that dysfunction of this system can help explain why people with IC also have other conditions such as endometriosis, irritable bowel syndrome, levator ani syndrome, pelvic floor tension myalgia, vulvar vestibulitis, and vulvodynia. The dysfunction can amplify sensitivity to pain messages coming from the pelvic organs and also result in abnormalities nerves going to those organs and pelvic muscles that can build a vicious cycle of perpetuating pain. The cycle can be disrupted by blocking signals from the pelvic organs, either through anesthesia or muscle manipulation. The problem can also be addressed with drug or psychological therapy targeted to the limbic system. Working with this idea may produce specifically targeted therapies that could ease all these pains.

Pharmacists, Drug Developers Learn About IC
Theoharides TC. Treatment approaches for painful bladder syndrome/interstitial cystitis. Drugs. 2007;67(2):215-35.

This article for pharmacists and physicians interested in drug therapy and drug development reviews what IC is thought to be and what drugs are used in treatment. The author said that results with drugs are variable, that they usually work better together, and that lack of early diagnosis and treatment may lead to pain that's harder to treat.

OB/Gyns Educated about Botox
Sinha D, Karri K, Arunkalaivanan AS. Applications of Botulinum toxin in urogynaecology. Eur J Obstet Gynecol Reprod Biol. 2007 Feb 1; [Epub ahead of print]

This review article for obstetrician-gynecologists describes the activity of botulinum toxin (Botox) and its potential in pelvic pain and bladder disease. It may fill the void, the authors said, between anticholinergics and surgery in cases of overactive bladder, bladder sphincter problems, IC, and pelvic pain.

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

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

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 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/

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 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 Aloe Vera: Aloe vera is a powerful anti-inflammatory and pain reliever. A small clinical trial of Desert Harvest whole-leaf aloe vera capsules showed significant reduction in the symptoms of IC. Desert Harvest Aloe Vera’s active ingredient is a polysaccharide, which researchers believe may form an artificial GAG layer in the bladder.

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 www.desertharvest.com or call 1-800-222-3901.

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

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

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

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