Interstitial Cystitis (IC) is a chronic condition that is characterised by recurring pain or discomfort in the bladder and pelvic region. The disease has also been regarded as a precursor for multiple bladder conditions as the symptoms of IC may vary from patient to patient. Thus, the term “Painful Bladder Syndrome” or “Bladder Pain Syndrome” has been used interchangeably for Interstitial Cystitis by researchers. Thus, describing the painful urinary symptoms that may not fully meet the criteria for Interstitial Cystitis. In IC, the bladder wall gets irritated and scarred causing pinpoint bleeding (Glomerulations) or broken skin patches on the bladder wall (Hunner’s ulcers).
The prevalence of interstitial cystitis has been diversified depending on the country of origin and the diagnostic criteria. The disease is more prominent in women than in men.
Recent studies on interstitial cystitis estimate that in the United States, about 2.7% to 6.5% women have consistent symptoms with the diagnosis of disease. In 2004, the United States Nurse Health Study showed that the prevalence of IC is 2.3% and the annual incidence rate estimation is 2.6 cases per 100,000 women. Reports from Europe estimates that per 100,000 women the prevalence of IC is 18 cases while in Japan only 3-4 cases have been reported.
The difference in the epidemiological data among different countries is due to the difference in diagnostic criteria.Currently, Elmiron is the only USFDA approved drug in the market for the treatment of IC. Further, bladder instillations have been in use for reduction of IC related symptoms. Bladder instillations are the second line of treatment for IC/PBS. It is used when diet modification, stress management, and over-the-counter products become ineffective. Medication cocktails that are used in IC treatment include RIMSO-50 (dimethyl sulfoxide), Lidocaine, Marcaine, sodium bicarbonate etc. These medications are instilled in the bladder with the help of a urethral catheter. Though bladder instillations do not cure the disease completely they provide symptomatic relief when the therapy is given regularly for a certain time period.
The lack of significant research activity in IC segment remains a major unmet need. Companies like Urigen, Astellas, Aquinox, Allergan, Lipella and Urogen are majorly active in this space, indicating plenty of scope for research in this area owing to its narrowing pipeline.