News in pelvic pain

What we’re doing at the Smith Institute for Urology to help you…

Dr. Barbara Shorter, Associate Professor of Dietetics Joins The Smith Institute for Urology

As many of our patients know, Dr. Barbara Shorter, EdD, RD, CDN Associate Professor of Nutrition and Director of the undergraduate Nutrition Program at Long Island University, has been volunteering her time every other Friday to counsel IC patients.

Well…we are very happy to report that Dr. Shorter has now joined our faculty! She’ll be seeing interstitial cystitis patients but also giving expert advice on the nutritional aspects of many other urological conditions such as kidney disease and urological cancers.

Barbara Shorter received her Doctorate in Nutrition Education from Teachers College, Columbia University. She is a registered dietitian with the American Dietetic Association and is a Certified Dietitian/Nutritionist NYS. Dr. Shorter is an Associate Professor in the Department of Nutrition at the CW Post Campus of Long Island University (LIU) and Director of the Didactic Program in Dietetics. She recently joined the faculty of the Smith Institute for Urology where she provides nutritional counseling in facets of urology including, pelvic pain, prostate cancer, kidney stone disease, and renal failure.

Dr. Shorter’s research focus is on Interstitial Cystitis/Painful Bladder Syndrome(IC/PBS). She was lead author of “Effects of Comestibles on Interstitial Cystitis/Painful Bladder Syndrome” published in the Journal of Urology (2007). Currently, she is examining the effects of foods and beverages on the symptoms of Chronic Prostatitis/Chronic Pelvic Pain Syndrome, and, determining the effects of caffeine on the symptoms of IC/PBS. Barbara has recently co-authored the new dietary guidelines for IC/PBS patients entitled “Understanding the Interstitial Cystitis/Painful Bladder Syndrome Diet” 2009 (ichelp.org). She has also published “ The Potential Role of Diet in the Treatment of IC/PBS in Topics in Clinical Nutrition, “Patients Hoping to Alleviate Pain Collide Against the Unknown Forces of the Disease” in Collide: Styles, Structures and Ideas in Disciplinary Writing.(2007) and “Dietary Changes Can Make a Difference in IC/PBS Patients with Food Sensitivities” Nutrition Today (in press). In addition, she was a guest speaker for the Interstitial Cystitis Network, the Long Island Dietetic Association, CW Post Long Island University Honors Program and the Smith Institute for Urology IC Support group. Barbara has recently been invited to serve as a Medical Advisory Board Member of the Interstitial Cystitis Association.

Prior to Dr. Shorter’s positions in the Academic arena, she was Chief Dietitian for the Catholic Medical Center, and, Senior Nutritionist at the NYU Medical Center Hospital, NYC.

Welcome aboard Barbara!!

Physical Therapy Position Just Approved for The Pelvic Pain Center!

As many patients are already aware, standard physical therapy techniques are often either ineffective or can worsen pelvic pain. Therefore, we generally advise any patient who suffers from chronic pelvic pain to see a physical therapist (PT) who specializes in this area. We are especially delighted announce that our Institute has just received approval for a specialist PT to join our faculty; at first on a part-time basis. As yet, we can’t announce the PTs name or credentials, but that information will come soon.
This PT will be one of a select few in the country to be on the faculty of a urologic facility.

Working with The National Institute’s of Health and The Office of Research on Women’s Health

Dr. Moldwin was an invited panelist for the National Institute’s of Health’s (NIH) Office of Research on Women’s Health (ORWH) held March 4-6th, 2009. The meeting was entitled “Moving into the Future: New Dimensions and Strategies for Women’s Health Research.” It was designed to help the NIH formulate its research priorities for the next 10-20 years. The meeting covered all areas of women’s health. Dr. Moldwin was present to plead for more dollars for research projects that would help interstitial cystitis patients. Also present representing the interests of IC patients was Barbara Gordon, the Executive Director of the ICA.

Some suggestions that came from the “Chronic Pain Syndromes” panel that Dr. Moldwin attended included:

Developing research strategies to investigate chronic pain syndromes as a “systemic” problem (that has manifestations in multiple systems in the body). This may help better establish why so many patients with IC also have problems like fibromyalgia, irritable bowel syndrome, migraine headaches, Sjögren’s Syndrome, vulvodynia, chronic fatigue syndrome, etc. This topic received the most attention and discussion.
Developing better ways to conduct trials for new therapies.
Developing better animal models for chronic pain syndromes. We had a very long discussion about this very complex topic.
Exploring issues related to clinician- patient interactions in the chronic pain patient. Differences in how people describe their difficulties which may vary on the basis of previous experiences, social environment, or sex.
The effect that factors such as hormones and diet may have on these pain syndromes
The great need for the development of a database system where clinical data from patients can be pooled together from multiple institutions

Other topics that were discussed included:

The need for chronic pain syndromes (including IC) to be included in the curriculum of medical schools. Currently, medical students typically graduate without even hearing of fibromyalgia, IC, vulvodynia, etc... no less being taught to manage such patients. Without a basic understanding of these conditions from their basic training, how do we expect any of these bright people to treat or become researchers in this area? We suggested that the ORWH take a role in mandating discussion of these topics in medical school curricula.
Pharmaceutical companies apparently have lots of data on various medications which may show promise as future treatments for patients in pain. We would like to see some of these data voluntarily released, thereby giving researchers some groundwork for the development of future therapies.

Working to Develop New “Tools” to Help the Interstitial Cystitis Patient

How can we tell if a therapy is working? Well, in the office setting, it’s not too difficult. The patient tells us that they’re feeling better perhaps because they’re having less pain or they’re not voiding as frequently, or they’re just sleeping better at night. Conversely, they may tell us that nothing has changed…or worse, they’re having side effects from the therapy.

Unfortunately, things aren’t so simple when investigating a new, potentially helpful drug. In this instance, we need to do a double-blinded, randomized, placebo-controlled study. “Placebo controlled” means that some patients may not get the “real” medication. These patients who get the placebo pill or bladder instillation often have very impressive symptom improvements. In fact, the percentage of patients that can have a good result from the placebo can be as high as 15-40%! We always compare the response from the placebo to the response from the real medication and make sure that there’s a significant difference between them. “Randomized” means that it’s not up to us whether a patient receives the real medication or the placebo; the decision is often made by a computer. The randomization process takes away any bias from the investigator. The term “double-blinded” mean that both the investigator and the patient have no idea what is being administered, placebo versus the real medication.

But assuming all of this is done properly, how do we evaluate whether a medication is working? The answer… in the field of pain and bladder complaints, we use questionnaires. Many patients have already filled out tons of questionnaires to monitor their clinical progress. Some simply ask you to rate your pain on a 1-10 scale. Others, like the O’Leary-Sant Symptom and Problem Index and the Pain, Urgency, and Frequency Scale ask lots of questions, ultimately resulting in a score that can be monitored. Now more problems arise. It appears that these scoring systems will not satisfy the FDA for future drug evaluations due to a variety of problems. So…what do we do now? We need to reconstruct our evaluations.

In order to help reconstruct Dr. Moldwin met in the United Kingdom from Jan 14-17th , 2009 with members of the European Society for the Study of IC (ESSIC) and members of the pharmaceutical industry to develop new methods to monitor patient progress. We hope that the questionnaire that results will be applicable for studies in the United States as well as in other countries including, Italy, Germany, and France. Ultimately, the new questionnaire will be acceptable to our FDA and will be published such that investigators around the globe (and most importantly, the patients) will benefit.

Ongoing Clinical Research…
Closing of Interstitial Cystitis Study BUT Beginning New Study!

Nerve Growth Factor Immunoglobulin and IC

Nerve Growth Factor (NGF) is involved in the generation of pain in our bodies. Initial work in severe arthritis patients has shown that an intravenous injection of an NGF immunoglobulin resulted in a reduction of pain; and it was therefore elected to see if the same medication could help those with other pain disorders such as IC. Some of our wonderful IC patients graciously elected to be part of that trial and the results will be analyzed shortly. At present, that trial is closed
BUT…
We are likely to be evaluating a NEW THERAPY INSTILLED DIRECTLY INTO THE BLADDER within the next few months. This is very exciting news and we will keep you posted when this study hopefully begins. If interested, please call Dori DeJesus at 516-734-8515.

Finally, A New Potential Therapy For The Chronic Prostatitis/ Chronic Pelvic Pain (CP/CPPS) Patient

As you may have read above, nerve growth factor (NGF) may be a source of pain for IC patients, but may also be a source of pain for those men afflicted with CP/CPPS. An immunoglobulin that binds NGF is administered and patients are subsequently monitored for efficacy and any side effects. We will soon be enrolling patients for this study. If interested, please contact Dori DeJesus 516-734-8515.

Does Caffeine Actually Have An Effect On IC Symptoms?

We have shown through questionnaire-based research that coffee is the most common food or beverage to worsen IC and prostatitis related symptoms. We often assume that it must be the caffeine in the coffee that’s the culprit, but that’s not necessarily true. The current study conducted between the Smith Institute for Urology and CW Post (Dr. Shorter) investigates this issue by testing the “coffee sensitive” patient’s response to a relatively low dose of caffeine or to a placebo. We believe that many patients may actually not be sensitive to the caffeine. This is an interesting study that may actually serve a role to better guide patients with their diets. We anticipate starting this study by April 1st. If interested in participating in this study, please contact Marina Ruzimovsky 516-734-8512.

Does Instilling An Anesthetic Into The Bladder Actually Increase Its Capacity?

For many IC patients, an anesthetic instilled directly into the bladder can lead to a profound, often long-lasting improvement in symptoms. But does it actually allow you to hold more urine in your bladder or does it just make you feel better? This study simply involves performing a standard test for bladder function called urodynamics. This is a test that uses a very skinny tube (called a catheter) that’s placed into the bladder. The catheter then fills the bladder with sterile water and various measurements of bladder function and capacity are recorded. Patients who can’t tolerate any catheter are probably not good candidates for this study. During the study, some patients will receive an anethetic into the bladder while others won’t. Ultimately, every patient will have the anesthetic instilled. The benefits to the patient include knowing whether their bladder capacity is actually improving and for those patients who have never had an anesthetic placed into their bladder, this instillation may open up a new world of potential therapy. If interested in this study, please contact Marina Ruzimovsky 516-734-8512.

Pelvic Floor Trigger Points and Your Pelvic Pain

We’ve learned over the past 15 years that most patients with interstitial cystitis, vulvodynia, and prostatitis have associated tenderness of the pelvic floor muscles. These are the muscles that support structures like the bladder, vagina, rectum, and prostate; and have important roles in urination, defecation, and being sexually active. The pelvic floor muscles can be a significant source of pain in some patients, even to a point where they cause more pain than the primary problem (like interstitial cystitis). We are currently investigating whether tender points found in the muscles of the pelvis (called “trigger points”) correspond to the location of the patients’ pain. Enrolled patients will be examined by a specialized physical therapist who will perform a comprehensive exam of the pelvis and we will be comparing those exam result to the location of their pain. Although the physical therapist can’t make any specific recommendations for treatment, the patients will obtain an excellent comprehensive evaluation of pelvic muscles. If interested in this study, please contact Ms. Donna McKay for an appointment 516-734-8565.

The Annual American Urological Association Meeting 2009

The American Urological Association (AUA) Annual meeting in Chicago (April 25th – April 30th) was a huge success for patients suffering from pelvic pain. Five sessions (both podium and moderated poster sessions) were devoted to Infectious and Inflammatory diseases in Urology; and two of those sessions dealt almost entirely with urological pelvic pain, including prostatitis (chronic prostatitis/chronic pelvic pain syndrome – CP/CPPS) and interstitial cystitis (IC). During the plenary sessions which were filled with thousands of urologists from across the globe, speakers presented on topics such as the similarities between interstitial cystitis and prostatitis (Kristene Whitmore, MD), understanding the multifaceted clinical picture of the IC patient (Curtis Nickel, MD), and a relook at the use of amitriptyline in the IC patient (Philip Hanno, MD). Dr. Moldwin presented the highlights of the sessions which can be found here.

Two courses and two “lunch with the experts” programs were devoted this year to interstitial cystitis and its treatment. One of those courses was directed by Dr. Moldwin. For more information on the courses and new data on food sensitivities in IC and CP/CPPS patients, please check out the ICA website.

In addition to the regularly scheduled meetings at the American Urological Association, the Society for Infection and Inflammation in Urology (SIIU) held its annual meeting. The Keynote speaker was Dr. David Klumpp from the Department of Urology at Northwestern University. Dr. Klumpp gave a superb lecture on organ cross-talk as a source for chronic pelvic pain, a topic that may have a profound impact on our future care of patients suffering from conditions such as IC and CP/CPPS. During that meeting Dr. Moldwin was confirmed as President of the Society for 2009-2010.

Some of the latest news from the AUA Meeting….
1. Various differences may exist in urinary protein expression between interstitial cystitis (IC) patients and those without IC. This suggests that “urinary proteomics” may provide insight into the cause of IC and/or aid in the development of new “markers” for this condition.
2. Nerve growth factor was found to be elevated in the urine of IC patients and in patients with overactive bladder and even in patients with varied lower urinary tract symptoms
3. Patients with IC appear to have significant biosocial impairment as compared to the population at large. Also, conditions such as irritable bowel syndrome, fibromyalgia, and chronic fatigue syndrome were more frequently seen in the IC population
4. The Rand Interstitial Cystitis Epidemiology study evaluated almost 100,000 US households and found the prevalence of IC type symptoms in women to be 3-6%, a significantly higher prevalence than previous studies. This suggests that IC symptoms may exist in over 4 million women in the United States!
5. Botulinum toxin A (100 units) into the bladder base (trigone) improved the symptoms of all 17 patients in one study. At 9 months follow up, 7 patients requested another injection due to return of symptoms.
6. In another Botulinum toxin A related study, Botulinum toxin A appeared to enhance the clinical effect of bladder hydrodistention.
7. Antiproliferative factor (APF) is a chemical found in the urine of most IC patients and may be a cause of symptoms. Two new agents have shown promise as APF inhibitors in the laboratory setting.
8. Both IC patients and patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) had a high prevalence of food sensitivities, but IC patients still had about twice the prevalence as the CP/CPPS patients.
9. A clinical phenotyping system termed “UPOINT” (Urinary, Psychosocial, Organ specific, Infection, Neurologic/Systemic, Tenderness of pelvic floor muscles) was developed to better understand the cause of and best therapies for CP/CPPS.
10. In a randomized, double blinded study, pregabalin (Lyrica®) was not found to be better than a placebo group in the treatment of CP/CPPS…BUT..when evaluating “secondary endpoints” such as global improvements, significant differences where found, suggesting a role for this medication in the treatment of CP/CPPS.

Recent Literature from the Pelvic Pain Center at The Smith Institute for Urology

Kaye JD, Moldwin RM. Interstitial Cystitis in Men: Diagnosis, Treatment, and Similarities to Chronic Prostatitis. In: Prostatitis ed. Shoskes D, Humana Press, Towtowa, NJ, 2008, pp 189-208.

Kaye JD, Srinivasan A, Moldwin RM. Urologic pelvic pain: Diagnosis and management. Urology Times Clinical Edition. 2008; 3:S4-10.

Cinman N, Moldwin R. “Interstitial Cystitis,” In: 5-Minute Urology Consult, ed. G Gomella, (in press), 2008

Srinivasin A, Moldwin R. “UTI in the Adult Female,” In: 5-Minute Urology Consult, ed. G Gomella, (in press), 2008.

Huckabay C, Moldwin R. Cystocele and Enterocele, In: 5-Minute Urology Consult, ed. G Gomella, (in press), 2008.

Moldwin R, Smith DA, et al. A Quick Reference Guide for Clinicians: Diagnosis and Management of Interstitial Cystitis/Painful Bladder Syndrome. Washington, DC; 2008.

Clinical Proceedings: Screening, Treatment, and Management of Interstitial Cystitis/Painful Bladder Syndrome. Washington, DC; 2008.

Forrest JB, Moldwin R. “Diagnostic options for the early identification and management of IC/PBS.” International Journal of Clinical Practice. 62 (12), 1926–1934, 2008

Cinman, Huckabay, Moldwin. Female Sexual Pain Disorders: Evaluation and Management., Blackwell-Wiley, Editors: Andrew Goldstein, Caroline, Pukall, Irwin Goldstein, 2009.

Theoharides TC, Whitmore K, Stanford E, Moldwin R, O’Leary M. Interstitial Cystitis: bladder pain and beyond. Expert Opinion on Pharmacotherapy, 2008, 9(17):2979-94.

Braunstein R, Shapiro EY, Kaye JD, Moldwin RM. The role of cystoscopy in the diagnosis of Hunner's ulcer disease, J Urol, 2008, 180:1383-1386.

Nickel JC, Moldwin R, Lee S, Davis EL, Henry RA and Wyllie MG. Intravesical alkalized lidocaine (PSD597) offers sustained relief from symptoms of interstitial cystitis and painful bladder syndrome. BJU Int. 2008 (in press).