ICA @ AUA

IC’s Big Day

Monday was an exciting day for IC here at the American Urological Association’s annual meeting including a course on pelvic pain and IC, big news on a new drug for IC pain, a lively debate about what IC is and what to call it, another presentation of AUA’s IC guidelines, and research sessions with presentations of more than a dozen studies important for IC. 

Continuing Medical Education Course on IC

Bright and early at 6 am, Robert Moldwin, MD, who is a member of the ICA Medical Advisory Board, and Jennifer Fariello, MSN, CRNP, a nurse practitioner who works with ICA Medical Advisory Board member Kristene Whitmore, MD, helped the nearly 100 urologists and other health professionals attending to understand how to recognize and treat, not only IC and pelvic floor dysfunction, but also many of the gynecologic conditions that go along with it.

Watch clip of Jennifer Fariello, MS, CRNP on ICHelp YouTube Channel

Hopeful New Pain Medicine

In a late-breaking news session, Robert Evans, MD, another ICA Medical Advisory Board member, spoke about the promise of nerve growth factor inhibitors for IC, the results of a preliminary trial of one of them in IC patients, and the plans for a major new trial that you have already been signing up for.

The drug in these IC trials, called tanezumab, from Pfizer, was given as an infusion once and brought down pain scores by about 2 points on the 0 to 10 point scale, which was statistically significant. It had no effect, however, on frequency, the volume of urine voided, or the Interstitial Cystitis Symptom Index score. The new trial will test different doses of the drug as an injection.

Nerve growth factor inhibitors have the potential to ease pain in a number of pain conditions, such as chronic prostatitis/chronic pelvic pain syndrome, rheumatoid arthritis, osteoarthritis, burns, and low back pain, and are being researched in some of these. Other companies working on nerve growth factor inhibitors for pain are Abbott Laboratories, Johnson and Johnson, Sanofi-Aventis, and Regeneron.

More on IC Treatment Guidelines and the Name Game

The large audience at the plenary sessions in the morning heard about IC guidelines, which are still pending final approval. They also heard a lively panel discussion among IC experts about what IC is and what to call it, which may mean that the term used for IC in the guidelines, IC/bladder pain syndrome (BPS), may change as the guidelines are finalized and published.

Alan Wein, MD, who is co-chair of the ICA’s Medical Advisory Board, asked the panelists about the proposed change in the nomenclature, what that might mean for IC patients’ care, and whether IC was a bladder or whole-body condition—and whether that mattered. Jorgen Nordling, professor of urology at the University of Copenhagen in Denmark explained ESSIC (originally known as the European Society for the Study of IC, now referred to by the acronym ESSIC), proposed the term “bladder pain syndrome” because these European urologists believe the term “interstitial cystitis” may lead clinicians down the wrong diagnostic, treatment, and research paths, looking for pinpoint bleeding in the bladder, which may not really be diagnostic; treating for inflammation, which may not be there; and using animal models of IC that may not translate to humans with the condition.

Christopher Payne, MD, a member of the ICA’s Medical Advisory Board, argued forcefully that there are practical and philosophical reasons for sticking with the term IC. While conceding that most patients do not have identifiable inflammation in their bladder, he pointed out that saying we don’t know whether patients have an actual cystitis is not the same as gaining knowledge and understanding of the disease and that the legacy should still be part of the name. “We’re not children in a playhouse changing from cowboys to pirates. We have to wait until we have real information because our changes in name have huge impacts on the patient and on the system,” he said.

Research hasn’t been adequate to make decisions about whether IC is a whole-body or bladder disease and what bladder characteristics really mean, said Dr. Payne. One small study, for example, isn’t enough to dismiss glomerulations (pinpoint bleeding) in the bladder as meaningful. Many patients do have a clear bladder disorder, and it’s not clear what that should be called in the new proposal.

The impact on patients and the system of care could be huge. “We have to deal, in this country, with the finances,” said Dr. Payne. A name change could spell difficulty with the insurance codes doctors need to get paid and for patients to get covered “I’m sure all of you have struggled with getting bladder instillations and expensive drugs covered,” he said. Plus, there will no longer be a clear path to disability for patients who need it without the term IC.

Panelist Deborah Erickson, MD, also a member of the ICA’s Medical Advisory Board, echoed similar concerns. Although she said that calling the condition a syndrome helps doctors and patients recognize that there may be more than one pain generator, inevitably the bladder needs to be treated. Nevertheless, she pointed out reasons to use “interstitial cystitis.” First, she said, it’s a good term for patients to use because it sounds medical and generates sympathy. “I’m not sure if you’d get the same sympathy with, ‘I’m having a bad day from my bladder pain syndrome,’” she said. Like Dr. Payne, she pointed the potential problems with insurance coverage and disability determinations, which she noted is a long and difficult process and that taking away a term that the Social Security Administration now recognizes might make it difficult for patients who can’t work to get what they need.

Afternoon Sessions Highlighted More Hopeful Treatment Options

The scientific sessions that followed brought news of effective treatment, new potential treatment approaches, and a potential new marker of IC.

Dr. Payne presented the final results of the controlled, randomized trial of pelvic floor-directed physical therapy in women with IC, which showed very positive results. The difference between that and general massage were clear, with many more women who got pelvic floor-directed physical therapy feeling either moderately or markedly better. Although the study had its limitations, it is only the second time that a randomized, controlled trial has shown definite positive results for an IC treatment, so more doctors should be referring patients to physical therapists experienced in these techniques and insurers giving better coverage for it.

Other treatments being researched include injection of a steroid drug into Hunner’s lesions, which looked helpful, although other urologists who have tried it haven’t seen as positive results. In a mouse model of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) that showed the mice had activated mast cells, a combination of two different types of antihistamines and a mast cell stabilizer reduced pain. Mast cell activation is thought to play a role in IC, and this may mean that combination therapy, rather than just one antihistamine, might help patients with IC or CP/CPPS. The first trial on the instillation of liposomes (tiny fat bubbles) into the bladder to coat and protect the lining, was also presented here, showing good results. Not only did patients feel better, but also the insides of their bladders looked much healthier and less inflamed.

New Diagnostic Tests Could Be on the Horizon

Some basic gene therapy research suggested that measuring certain cytokines in urine could gauge the degree of inflammation in the bladder. Another study showed that endothelin 1, a protein that causes blood vessels to constrict, showed up in significantly higher levels in IC patients’ urine and may play a role in the destruction of their bladder lining.

Today will also bring more news about IC treatments and late-breaking news about another marker that could become a test for IC, so stay tuned.

Posted June 01, 2010