March 3, 2011 — A greater understanding of interstitial cystitis/bladder pain syndrome (IC/BPS) has led to the development of the first-ever clinical guideline on the diagnosis and treatment of the condition.
The full text of the evidence-based guideline, issued by American Urological Association, is available on the association's Web site. An executive summary will be published in an upcoming issue of the Journal of Urology.
"IC/BPS affects a significant number of patients whose quality of life is severely diminished by this complicated, frustrating condition," Philip Hanno, MD, who chaired the multidisciplinary panel that developed the guideline, said in a statement from the American Urological Association.
"This population has historically been both under-recognized and under-served, and it is our hope that this guideline provides physicians with a much-needed road map to help treat these patients," he noted.
Evolving Science Behind ICS/BPS
In an interview with Medscape Medical News, Dr. Hanno noted that an attempt was made back in 1999 to develop a guideline for IC/BPS, "but after doing a literature search, we realized we didn't have enough data to put a guideline together." That has changed.
"Over time," Dr. Hanno explained, "interest in the disorder exploded, and the prevalence seemed to be increasing because of better epidemiology studies, and we felt that there was a lot of mismanagement of the symptom complex and failure to recognize it. We felt it was really important to put together a guideline for clinicians, and luckily at this time there was enough data to do it."
However, in terms of diagnosis, the panel says "insufficient evidence" was retrieved; therefore, this portion of the guideline is based on clinical principles and expert opinion. The key recommendations are as follows:
- The basic assessment should include a careful history, physical examination, and laboratory examination to rule in characteristic IC/BPS symptoms (including sensations of pain, pressure and discomfort perceived by the patient to be related to the bladder, and absence of infection, as well as marked urinary urgency and frequency), and rule out easily mistakable disorders (such as overactive bladder or, specifically in men, chronic prostatitis).
- Baseline voiding symptoms and pain levels should be obtained to measure subsequent treatment efficacy.
- Cystoscopy and/or urodynamic studies should be considered as an aid to diagnosis only for complex presentations; these tests are not necessary for making the diagnosis in uncomplicated presentations. Although there are no existing cystoscopic or urodynamic findings specific for IC/BPS, the guideline states that these tests can be valuable in identifying lesions or alterations (Hunner's lesions) in the bladder in patients with symptoms, and in ruling out other entities such as bladder cancer or urethral diverticula.
Dr. Hanno made the point that IC/BPS is often misdiagnosed as overactive bladder or prostatitis in men, and that therefore the diagnosis is delayed. "Some patients are treated as if they have recurrent urinary tract infections, and they will be on antibiotics for months or years without proper diagnosis, or on anticholinergics for years if it is diagnosed as overactive bladder and they don't get better. Identifying IC/BPS early and treating it early can certainly impact a patient's quality of life," Dr. Hanno said.
Best Treatment Unclear
At this time, there is no cure for IC/BPS, and for most patients, no single treatment works well over time, the panel notes. Their review yielded an evidence base of 86 treatment articles. When sufficient evidence existed, the body of evidence for a particular treatment was given a strength rating of A (high), B (moderate), or C (low). As with diagnosis, when the evidence for a particular treatment was insufficient, the information was provided as clinical principles and expert opinion. Guidance for overall management of IC/BPS includes the following:
- Strategies should start with the most conservative treatments first before moving to less conservative therapies.
- Initial treatment type and level should be related to symptom severity, clinical judgment, and patient preferences. Patients should be counseled with regard to reasonable expectations for treatment outcomes.
- Some patients may benefit from multiple, concurrent treatments; baseline symptom measurement and regular assessment are critical to document the efficacy of combined vs single treatments.
- Ineffective treatments should be stopped once a clinically meaningful interval has elapsed.
- Pain management and its effect on a patient's quality of life should be regularly assessed and considered. If pain management is inadequate, then consideration should be given to a multidisciplinary approach, and the patient referred appropriately.
- If no improvement in symptoms occurs after multiple treatment approaches, the diagnosis of IC/BPS should be reconsidered.
First-Line Treatment: Education
The guideline states that the following first-line treatments "should be performed on all patients."
- ”Patients should be educated about normal bladder function, what is known and unknown about IC/BPS, the benefits vs risks/burdens of available treatment alternatives, the fact that no single treatment has been found effective for most patients, and the fact that acceptable symptom control may require trials of multiple therapeutic options (including combination therapy) before it is achieved,” the authors write.
- Patients should be counseled on how certain self-care practices, behavioral modifications, and coping techniques such as stress management may help manage their IC/BPS symptoms.
- The guideline also outlines second-, third-, fourth-, fifth-, and sixth-line treatment options and includes an algorithm outlining a hierarchy of physical and medical therapies, as well as surgical options for IC/BPS. "There is a lot of leeway in the guidelines, so people have the ability to do what they think is right," Dr. Hanno said.
What Not to Do as Important as What to Do
However, according to the guideline, the following treatments should not be offered because of lack of efficacy and/or unacceptable adverse effects:
- long-term oral antibiotics,
- intravesical instillation of bacillus Calmette-Guerin outside of a study setting,
- intravesical instillation of resiniferatoxin,
- high-pressure, long-duration hydrodistension, and
- systemic (oral) long-term glucocorticoid administration.
"This guideline will improve the ability of primary care physicians and specialty physicians (urologists, gynecologists) to diagnose IC/BPS, and then it will aid them in treatment options, as well as avoid certain treatments that have been proven to not be worthwhile," Dr. Hanno told Medscape Medical News.
"It's directed at all physicians," he emphasized, noting that "primary care physicians need to recognize this condition and then make the appropriate referrals to physicians who have some expertise in managing it."
The Interstitial Cystitis Panel was created in 2008 by the American Urological Association Education and Research, Inc. Funding of the panel and the Practice Guideline Committee was provided by the American Urological Association. Members of the Guideline Committee have disclosed financial relationships with Abby Moore Medical, Afferent Pharma, Allergan, AMS, Antreras, Astellas, Astra Zeneca, Bayer Corporation, Bioform, Eli Lilly, Ferring Inc, GlaxoSmith, Hollister, Johnson and Johnson, Lipella, Merck, NeurAxon, Pfizer, SCA Personal Products, Taris Biomedical, Trillium Therapeutics Inc, United Biosource Corporation, Verathon Medical, and Watson.
Medscape Medical News © 2011