Interstitial cystitis (IC) is a common entity with significant quality of life effects. However, the exact prevalence and incidence of IC is unclear as prior attempts to address this used solely administrative claims data or referral patterns from tertiary care referral centers. In order to define the national prevalence and incidence of IC, we propose a study using nation-wide data pulled from the Veterans Affairs (VA) Medical Centers, the largest integrated health system in the country. The goals of our team are to identify every IC patient within the VA system, to dive deep into the medical records of these patients to confirm the diagnosis of IC using a combination of automated data pulls plus hand-abstraction, to determine what other comorbid conditions co-exist with IC, and to assess treatment patterns and outcomes. Our study, by using an innovative approach to tap into nation-wide data, holds the potential to shed tremendous light on a disease of which to date we know very little. Our goals in this proposed study are to estimate the US nationwide prevalence and incidence of interstitial cystitis (IC) using a large, heterogeneous cohort from the Veterans Affairs healthcare system, the largest integrated health care system in the US. We will also prospectively enroll subjects to identify the impact of IC on individual health and test the value of a specific set of urine biomarkers already identified by our research team to diagnose IC. This study will dramatically enhance our understanding of the epidemiology of IC and will be the basis for multiple prospective studies aiming to increase diagnostic accuracy, and thus has direct relevance to human health and patient care.

What is IC?

Interstitial cystitis (in-ter-stish-uhl sĭ-stī’tĭs) is a chronic bladder dysfunction that usually consists of multiple symptoms including recurring pelvic pain, pressure, or discomfort in the bladder and pelvic region, and urinary frequency (needing to go often) and urgency (feeling a strong need to go). IC is also called as painful bladder syndrome (PBS), bladder pain syndrome (BPS), and chronic pelvic pain in clinic.

The burden of interstitial cystitis/painful bladder syndrome (IC) on the American public is immense in both human and financial terms. According to the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU), IC is defined as “an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes”. There is significant overlap in symptoms between IC, overactive bladder syndrome (OAB), vulvodynia and endometriosis in women, and chronic prostatitis and chronic orchalgia in men. However, the major distinguishing feature of IC, according to NIH guidelines, is the presence or absence of pain.

The prevalence of IC for women in the literature has ranged from as low as 0.045% in administrative claims data to 6.5% in a population-based telephone study. Similarly, for men, estimates range from 0.008% in administrative claims analyses to 4.2% in a population-based telephone study.

Despite the great burden of IC on public health, the diagnosis of IC remains challenging and is often subjective in current clinical practice. Many diagnostic tests for IC exist, and include urinalysis, urine culture, potassium sensitivity testing, cystoscopy, biopsy of the bladder wall and hydrodistention of the bladder. However, none of these tests can definitively diagnose IC. Thus, differentiating IC from other conditions is still a diagnostic challenge, and objective diagnostic markers are urgently needed to definitively diagnosis the condition. In fact, it can take up to 4-5 years from the first visit to definitively diagnose IC.

Treatment options for IC are suboptimal likely due in part to the lack of adequate diagnostic tools. Pentosan polysulfate (Elmiron) is the first FDA-approved oral drug for IC, however only 30-60% of patients experience temporary relief of symptoms. Side effects from Elmiron are significant and include hair loss and gastrointestinal disturbances. Furthermore, Elmiron’s mechanism of action remains unclear. Beyond Elmiron, few other treatments are effective. For example, using a national random sample of claims data from Medicare beneficiaries, we previously found that sacral neuromodulation had significantly worse results with IC patients than was the case with other conditions with similar symptoms. A lack of understanding of the origins of IC and of the underlying mechanism(s) has inhibited the development of effective methods for prevention and/or treatment. Thus, the identification of the etiology of IC has the potential to greatly improve the accuracy of IC diagnosis and effectiveness of therapy.

IC is associated with significant impairment in quality of life. Compounding the lack of effective treatment is the fact IC symptoms result in marked detriments in physical and social activities and quality of life. In fact, disability from IC has been compared to other chronic illnesses including end-stage renal disease, diabetes, and chronic lung disease. One study found suicidal ideation in 11% of women with IC. IC also represents a large financial burden on the American public. Symptom severity with IC has been shown to predict missed days of work and long-term unemployment.

Please find more information on IC!

Interstitial Cystitis Association (ICA) website


CDC (Centers for Disease Control & Prevention) website