A Multidisciplinary Consensus Meeting on IC/PBS: Outcome of the Consensus Meeting on Interstitial Cystitis/Painful Bladder Syndrome, February 10, 2007, Washington, DC

The Washington, DC, Consensus Group on Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) met in February and produced majority statements defining IC/PBS and supporting the possibility of cautious and deliberate nomenclature change, both of which are in the excerpt below from the meeting’s report. The meeting was marked by animated discussion of these 2 key topics in which the choice of words and their implications were carefully considered. The 23 participants included researchers, urologists, obstetrician-gynecologists, pain specialists, nurse practitioners, a registered nurse, and a pharmacist. Three attendees with IC/PBS offered a patient perspective. The meeting was sponsored by the Association of Reproductive Health Professionals (ARHP) and the Interstitial Cystitis Association (ICA) and cochaired by Karen Berkley, PhD, MacKenzie Professor at the Florida State University Division of Neuroscience, and Robert Moldwin, MD, Associate Professor of Clinical Urology and Director of the Pelvic Pain Center at the Smith Institute for Urology, Long Island Jewish Medical Center. IC/PBS is a chronic debilitating condition characterized by pelvic pain, urinary urgency, and urinary frequency that affects an estimated 700,000 to 1 million people in the United States, most of them women.1 Actual prevalence may be significantly higher because of the lack of diagnostic criteria appropriate for clinical use. The strict diagnostic criteria developed for the research setting by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) have been shown to miss 60% of cases.2 Patients with IC/PBS often appear healthy but may experience unrelenting pain that requires frequent trips to the bathroom. Because of extreme urinary frequency, they may curtail their daytime activities—many are unable to work—and suffer sleep deprivation that can lead to fatigue and depression. Research has shown that patients with IC/PBS score lower on quality of life measures than patients with end-stage renal disease undergoing hemodialysis.3 The condition generated direct annual costs in the United States estimated at $428 million in 19873 and presumably that figure would be much higher in the present day.4 Uncertainty surrounds the definition, etiology, diagnosis, natural history, true prevalence, and most effective treatment(s) for this clinical syndrome. The gaps in knowledge stem from a very limited evidence base in the scientific literature and have a direct impact on patient care: on average, patients experience a lag time of 5 to 7 years before they receive a diagnosis of IC/PBS.4 Even the nomenclature regarding the condition has been the subject of controversy in recent years. Concerns have included the broadness of terminology, the loss of name recognition by patients with possible removal of the term “interstitial cystitis,” reliance of the diagnostic criteria on invasive testing not generally used in the US clinical setting, and problems with coding and reimbursement for medical insurance, disability coverage, and prescription medications, which may adversely affect patients.5 In addition to the 2 majority statements, participants discussed the currently available diagnostic criteria for IC/PBS. The group agreed that the NIDDK diagnostic criteria need to be updated and concluded that 2 sets of criteria are needed: one set of core criteria for NIDDK research trials and a second set for clinical diagnosis. The participants agreed that the criteria should be updated by a multidisciplinary, international group that includes health care providers, researchers, and patients, but excludes participation of industry representatives. The consensus group also identified key areas for additional study that might well involve collaboration between researchers and clinicians. These included normal voiding patterns, especially in relation to frequency, and the natural history of IC/PBS. The group called for more work on the development and validation of the definition of IC/PBS as well as supportive criteria for its diagnosis. The participants recommended clinical studies with follow-up on outcomes to evaluate symptoms, clinical presentations, and physical examination findings of IC/PBS, and long-term (> 20 years) studies of women and men with pelvic pain and urgency symptoms. The group also suggested development of a comprehensive registry and database of interventions to assess effectiveness and studies based on reliable tissue banks from carefully characterized patients. The ICA, ARHP, and members of the Consensus Meeting are planning a number of follow-up actions. The ICA is drafting a letter to NIDDK officials requesting consideration of the need for updated diagnostic criteria for the research setting. (The NIDDK is planning an international definition meeting for late 2007.) ICA and ARHP, guided by an independent expert advisory committee, will collaborate on developing an array of educational materials for the public and health care providers. These include a curriculum for live and web-based educational sessions, a clinical monograph, a best practices guide for clinicians that would provide evidence-based guidance where available and qualitative expert opinion where the evidence base is lacking, and patient education brochures in English and Spanish. Majority Statements from the Washington, DC, Consensus Group on IC/PBS 1. Definition of IC/PBS After considerable discussion, the majority of the meeting participants accepted the following as a definition for IC/PBS: Pelvic pain, pressure, or discomfort related to the bladder, typically associated with persistent urge to void or urinary frequency, in the absence of infection or other pathology. Meeting participants debated about the inclusion of the term “urinary frequency” alone and concluded that the addition of “persistent urge to void” helped to distinguish the symptoms of IC/PBS from those of overactive bladder (OAB). In addition, participants discussed whether the definition should specify that urinary frequency is precipitated by or associated with pelvic discomfort. The group decided against this addition based on input from patient members. The large group also debated whether IC/PBS represents a systemic disease or is localized to the bladder. The group concurred that the condition sometimes appears to be initially localized to the bladder, later evolving into a systemic disease, but in other cases appears be a systemic disease that affects the bladder. Participants agreed that there is currently a deficiency of evidence-based literature in this area. Participants also agreed that the results of currently available diagnostic techniques—in particular cystoscopy with hydrodistention under general anesthesia—often do not correlate with the severity of IC/PBS symptoms. 2. Is a Nomenclature Change Needed? After an in-depth discussion about changing the name of IC/PBS to bladder pain syndrome, the large group quickly arrived at a majority opinion: The nomenclature of IC/PBS may need to change, but change should not be undertaken now because there is insufficient evidence to support a change. Any change in nomenclature should be evidence-based. This group favors retaining IC in whatever name is considered in the future and positioning it first, as in IC/PBS. It was noted that a change in nomenclature could pose potentially adverse implications for billing and coding, disability insurance claims, pharmaceutical reimbursement, office visit reimbursement to both physician and patient, and name recognition. It also could have a major impact on comparative research studies worldwide. For these reasons, the group believes that if nomenclature is changed in the future, the term “interstitial cystitis” should be retained and positioned first. Excerpted from IC/PBS Meeting White Paper, available at http://www.arhp.org/healthcareproviders/visitingfacultyprograms/icpbs/whitepaper.cfm or http://www.ichelp.org/pressreleases/ICPBSWhitePaperFinal.pdf. Main Points Consensus group majority definition of interstitial cystitis/painful bladder syndrome (IC/PBS): “Pelvic pain, pressure, or discomfort related to the bladder, typically associated with persistent urge to void or urinary frequency, in the absence of infection or other pathology.” Consensus group majority statement on IC/PBS name change: “The nomenclature of IC/PBS may need to change, but change should not be undertaken now because there is insufficient evidence to support a change. Any change in nomenclature should be evidence-based. This group favors retaining IC in whatever name is considered in the future and positioning it first, as in IC/PBS.”