PARIS, FRANCE ( - Committee member Jorgen Nordling (Denmark) presented this committee's report, as Dr. Hanno was not present. He began by proposing a name change for the condition to Bladder Pain Syndrome (BPS) and remarked on the number of different names for this condition or symptom complex over the last several years. He next reviewed some historical points regarding the evolution of the diagnosis of Interstitial Cystitis (IC) and the NIDDK criteria for IC, which may be artificially narrow. In one study of 150 with clinically determined IC, only 60% of the women met the NIDDK criteria. He reviewed the 2002 ICS definition of Painful Bladder Syndrome and noted that the "suprapubic pain" and pain in relation to filling were the factors most responsible for the poor sensitivity. He noted the European Society for the Study of IC/PBS's definition of the condition that requires "chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder" plus at least one other urinary symptom to make a diagnosis. He also reviewed their classification system that is based on findings at cystoscopy with hydrodistention plus bladder biopsy.

Dr. Nordling then went on to the topic of conditions that are associated with "IC" and noted the lack of attention paid to this area, at least with respect to the urologic literature. This topic has been examined recently by what he termed "associated disease specialists". Many IC specialists believe the condition to more of a chronic pain disorder rather than a primary disorder of the bladder. Several studies were presented linking IC with fibromyalgia, irritable bowel syndrome, inflammatory bowel disease and panic disorder. Genetic linkages were also noted. Dr. Nordling presented a unifying theory regarding the etiology of BPS in diagram form. To summarize, bladder injury may cause a breach in the urothelial barrier function and cause leakage of potentially damaging substances into the interstitium. This can lead to a variety of downstream effects, including mast cell activation, allergic and immunological responses and c-fiber activation. This may lead to ongoing bladder injury and chronic stimulation of afferent pain fibers, which may lead to alterations in neurotransmission in the spinal cord or higher centers, and can produce a chronic pain state. Thus, even once the bladder injury phase has ceased, chronic pain may persist.

With respect to the initial evaluation and diagnosis of a patient with BPS, Dr. Nordling presented a long list of "confusable diseases", all of which can be ruled out with a careful history and physical, dipstick urinalysis and culture, ultrasound and urodynamic studies, and cystoscopy and bladder biopsy. BPS thus remains a diagnosis of exclusion. There are no validated questionnaires with good sensitivity and specificity for diagnosis, although several questionnaires are commonly used in monitoring disease and in clinical studies for outcomes.

The committee evaluated potential treatments for BPS. Conservative treatments such as physical therapy, behavioral modification, stress reduction and dietary changes all received Grade C recommendations with none achieving Level 1 evidence. For pharmacotherapy, the committee identified one randomized controlled trial and many non-controlled trials for amitriptyline and gave a Grade B recommendation on Level 2 evidence. Antihistamines were examined in an NIDDK RCT and were found to be ineffective, yielding a Grade D with Level 1b evidence. Immunosuppressants (cyclosporine) have been investigated and showed improved pain and frequency compared with Elmiron (Level 3 Grade C). Elmiron has been well studied, and although it is the only FDA approved medication in the U.S., the data from 5 RCTs is conflicting and it was given a Grade D on Level 1 evidence. Multiple intravesical treatments have been used in the treatment of BPS, and Dr. Nordling listed 10 separate preparations. The best results have been obtained with DMSO (Level 2 Grade B). There is Level 1 evidence for capsaicin, resiniferatoxin and BCG, but unfortunately efficacy has not been demonstrated (Grade D).

Apart from drug treatment, the committee evaluated several procedural therapies. Sacral neuromodulation was briefly mentioned and should be considered an investigational therapy until more data is available. Bladder distention has long been used for both diagnostic and therapeutic purposes. Although early reports were promising, more recent studies fail to show a significant benefit, and many studies are retrospective and not controlled (Level 3 Grade C). Endoscopic treatment of Hunner's Ulcers was examined, and several of the studies presented showed good symptom relief, although often of a short duration (Level 3 Grade C). More aggressive surgical options such as bladder augmentation, supratrigonal cystectomy and even urinary diversion have been employed and received a Grade C on Level 3 evidence.

The committee suggested several areas of future research. Of paramount importance is the development of a questionnaire with high sensitivity and specificity for BPS to assist in epidemiological data collection. The committee also suggested more attention be paid to associated disorders and the differences in BPS patients with and without these conditions. More work also needs to be done to identify biochemical tests (likely urine markers) that are specific to IC and can be used to identify patients for treatment or study. Finally, the committee recommended development of a multi-disciplinary care model, which can then be evaluated and compared to traditional care models.

There was a question regarding the inclusion of associated diseases and whether or not they should be included in the diagnostic criteria for BPS. Dr. Leroy Nyberg (U.S.) answered that there is indeed an ongoing trial regarding this issue and the multidisciplinary approach to BPS.

Moderated by Christopher Chapple, MD, and Willie Davila, MD, at the Fourth International Consultation on Incontinence (ICI) - July 5 - 8, 2008. Palais des Congres, Paris, France.

Phillip Hanno, MD, Committee Chair

Written by William Jaffe, MD, a Contributing Editor with UroToday.

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