IC/PBS has long been described as a ‘diagnosis of exclusion’. This means it is a diagnosis given when all possible causes of ongoing LUTS have been explored and excluded, including and most especially, infection. LUTS are a “broad group of signs and symptoms that include the urgency, frequency, and incontinence of overactive bladder, voiding problems such as hesitancy and intermittency, stress incontinence, and pain, all variously overlapping” (Kharisya, 2013).
Unfortunately, commonly used UTI tests (dipsticks and urine cultures) are incapable of excluding infection. They were never designed to exclude infection and their use in doing so has been strongly condemned by scientists for years. Regrettably, due to the failures of these tests and how they are interpreted, many people with chronic UTI are misdiagnosed with an incurable urinary syndrome (most commonly IC/PBS) and told they have to “live with it”.
While we do not dispute that there can be other causes of the symptoms often attributed to a diagnosis of IC/PBS, we believe that for a significant group of people, the underlying cause of their LUTS is likely not a ‘syndrome’, but a challenging, although treatable, chronic infection.
The Urological Society of Australia and New Zealand (USANZ) describes the primary symptoms of Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) as including pain (of the lower urinary tract, bladder, pelvis, abdomen, vagina, prostate, scrotum, penis), urinary urgency, and urinary frequency (PUF), (Female Urology SAG, USANZ).
The cause of IC/PBS remains unknown. However, multiple theories abound. So far, a variety of proposed causes of symptoms range from mast cell activation, food sensitivities, pelvic floor dysfunction, neurogenic dysfunction, and even psychological and psychosomatic disorders.
IC/PBS is described as a condition where the symptoms may be ongoing, they may flare-up, and increase in intensity and duration, or they may decrease to the point of remission, only to reoccur again years later. Some patients may be diagnosed initially with IC/PBS, but then go on to completely recover. In these instances, the individual is then generally considered to not actually have had IC/PBS in the first place, (Female Urology SAG, USANZ).
It is important to understand that being labelled with an incurable ‘urinary syndrome’ such as IC/PBS does not diagnose or provide an explanation of the cause of the symptoms—it merely acknowledges you have urinary symptoms. With this in mind, we will explore how the term Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) has evolved in recent years.
An insightful summary of the recent development of IC/PBS diagnostic criteria is provided in the text Cystitis Unmasked. In 1987 the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) set about to define a set of criteria for research purposes—bladder pain, urgency, glomerulations, Hunner’s ulcers/lesions, along with the absence of 18 exclusions. The NIDDK’s research definition soon became accepted as the new diagnostic criteria for IC.
A decade and a half later, a new set of recommendations was published by the International Continence Society (ICS) where it was recommended that Interstitial Cystitis ‘IC’, be renamed ‘Painful Bladder Syndrome’ (PBS). The name change created controversy as it excluded those with urinary symptoms not generally identified as painful, such as those diagnosed with overactive bladder syndromes (OAB). There was also debate surrounding who should receive a diagnosis of IC versus PBS. It was suggested that only those with Hunner’s ulcers/lesions should receive a diagnosis of IC, for those without, PBS would be applied. There was further effort made in some circles to break the diagnosis down into ‘subtypes’ with the intention of helping customise treatment, although it does not appear to have been widely adopted.
It did not end there; an additional term ‘Bladder Pain Syndrome’ (PBS) was also thrown into the mix—as was ‘Hypersensitive Bladder’ (HSB) . Then, as recently as 2021, a newly coined term to describe LUTS without positive urine culture — ‘UTILS’ (Urinary Tract Infection Like Syndrome)—was presented at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU21) conference in the United States. The attempt to introduce ‘UTILS’ failed spectacularly when patients took to social media in droves to express outrage at another new label to describe LUTS, adding to an already confusing landscape for researchers, clinicians and patients.
There is no conclusive diagnostic testing for IC/PBS. This is highly problematic. Currently, a diagnosis of IC/PBS takes a somewhat reductionist approach. It is a diagnosis of exclusion where the patient generally undergoes a series of invasive and non-invasive tests to exclude other possible causes which may be responsible for their ongoing lower urinary tract symptoms (LUTS). When these other possible causes are ruled out, yet LUTS remain, the patient receives a diagnosis of IC/PBS.
For the typical person undergoing IC/PBS investigations, the process often involves some, or all, of the following—UTI testing, urodynamic testing, transvaginal and pelvic ultrasound, CT and MRI scans, cystoscopy with or without bladder hydrodistension (stretching), urethral stretching and/or bladder biopsy. It has been reported that, on average, it takes three to seven years and three to five different practitioners before an IC/PBS diagnosis is reached.
Sometimes investigative tests for IC/PBS look to determine that symptoms do in fact originate from the bladder and not from another pelvic organ. A range of agents may be used to determine the origin of symptoms. One such test is the ethically dubious, invasive and painful potassium chloride bladder instillation, known as the potassium sensitivity test. If the patient feels pain during its administration into the urinary bladder, and an increase in symptoms, they may receive a diagnosis of IC/PBS. This test rests on an understanding that a bladder without damage to its urothelium will not experience any increase in pain with the introduction of an irritating agent, (Jiang, 2016). Yet, we now know that infection, particularly chronic UTI, may invade and damage the bladder lining (urothelium), and any substance which is not relatively pH neutral will cause pain if introduced to an inflamed bladder.
Another testing agent utilised more recently as a gentler alternative is intravesical lidocaine, an anaesthetic often used to numb sensations of pain. Lidocaine is instilled into the urinary bladder. If this reduces patient pain levels, then pain may be determined, quite reliably, as originating from the bladder, (Henry, 2016).
A cystoscopy with or without hydrodistension is commonly performed to look inside the bladder during the IC/PBS diagnostic process. Sometimes, a biopsy may be performed to rule out more serious conditions, such as cancer. Neither potassium sensitivity testing or hydrodistension have been found to be accurate for effectively diagnosing IC/PBS, (Jiang, 2016). Not surprisingly, while these tests may confirm a ‘painful bladder’, they fail to identify the cause of the pain.
Reaching a diagnosis of IC/PBS does not follow the same pathway for all. Some people will endure a full battery of tests before a diagnosis of ICPBS is made—some are diagnosed following a cystoscopy and hydrodistension procedure—others are given the diagnosis based solely on having UTI symptoms without the presence of one or more positive urine cultures.
Nonetheless, after all other causes have been excluded, either through a series of tests or by assumption, an IC/PBS diagnosis is made based upon the patient’s clinical symptoms, medical history and, most importantly, one or more negative, ‘normal’ urine culture tests to rule out urinary tract infection (UTI).
It is this reliance on cultures to rule out UTI in favour of a diagnosis of IC/PBS that patients find most challenging. Urine is not sterile, as was previously assumed. As we explain in detail on our UTI Testing page, urine culture tests were originally developed based upon a significantly defective understanding and we now know it is impossible to rule out UTI based on negative urine cultures. This is explained succinctly in ‘Cystitis Unmasked’: “All definitions of IC/PBS/BPS stipulate a crucial step—the absence of UTI. Unfortunately, the tests used to rule out UTI cannot rule out UTI and the risk of a missed infection is substantial” (Malone-Lee, 2020, p.73).
As explained by Professor Curtis Nickel, urine culture is an inferior diagnostic tool: “The microbiologic diagnosis of infection in the bladder has traditionally been based on cultivation techniques in which bacteria are grown from voided urine spread on culture plates, which does not have the nutritive and environmental conditions required to support the growth of many microorganisms. We now understand that these traditional tools used to study bacteria, not only in IC/BPS patients but also in patients with presumed bacterial cystitis, are inadequate as a means to survey the microorganisms present in patient samples” (Nickel, 2019).
It is hard to ascertain how many Australians suffer from a ‘urinary syndrome’ such as IC/PBS. Some estimates indicate that there are 65,000 people in Australia with IC/PBS, with 90 percent being female. Others have used population-based studies from the United States to suggest there could be 1.3 million Australian sufferers. There is a stark difference between those figures, which reflects the inconsistency and confusion from the lack of standardised diagnostic criteria, definitions and terminology.
In the United States, it is said that three to eight million women and one to four million men suffer with IC.
IC/PBS is considered an incurable, and sometimes progressive, condition. Various accepted pharmacological and surgical treatments are offered with the aim of attempting to manage symptoms. Many of these treatments are reported to have unpleasant side effects and low success rates, in addition to being highly costly. Patients commonly report these treatments worsen their symptoms.
In Australia, the mainstream treatments offered regularly include: dietary changes (to avoid triggers), pelvic floor physiotherapy, hydro-distension to stretch the bladder, anti-histamines to reduce inflammation, fulguration, Amitriptyline/Nortriptyline for pain, Elmiron designed to restore the bladder lining—also known as the glycosaminoglycan (GAG) layer—(long term Elmiron use is now understood to be toxic to the retina and can cause serious and permanent eye damage), Gabapentin to modify pain, DMSO (Dimethyl Sulfoxide, a chemical solvent), heparin, steroid bladder instillations, hyaluronic acid and chondroitin sulphate instillations (iAluRil) and Chlorpactin bladder rinses.
Surgical treatments are offered for worst case scenarios and include sacral neuromodulation to block nerves, urinary diversion and/or bladder removal (cystectomy) with a bag to collect urine outside the body, or bladder reconstruction using part of the bowel to form a larger bladder for those with reduced capacity and extreme frequency.
None of the accepted mainstream treatments for those with a diagnosed urinary syndrome, like IC/PBS, are targeted at addressing the cause of the symptoms. They are mostly invasive, expensive, on-going, and highly questionable considering there is little consistency within the evidence-base for their use. The side-effects are often extreme, intolerable and/or life-changing and, in some cases, proven to cause irreversible harm.
It cannot be ignored that the symptoms used to define IC/PBS (as described above) are the same distressing and painful symptoms associated with acute and chronic UTI.
IC/PBS is a diagnosis of exclusion. Yet, we know there are significant, serious shortcomings with the gold standard tests used to exclude the most common cause of bladder symptoms—urinary tract infection. This means it is currently impossible to use these tests to accurately exclude infection as a cause of LUTS. If UTI is not able to be ruled out (which is a stipulation for diagnosing IC/PBS), an IC/PBS diagnosis is not an acceptable outcome.
Until more reliable testing methods are developed, researchers have indicated that the patient’s symptoms, medical history and signals in the urine (white blood cells and epithelial cells)—as supported by the most current scientific evidence—should be introduced as first level diagnostic criteria.
So, is it possible that IC/PBS be an undiagnosed chronic UTI? In one word, yes. When looking for the cause of someone who presents with LUTS, we believe: