Management of PBS/IC (Painful Bladder Syndrome/Interstitial Cystitis) Abbreviated Prescribing Information can be found on the last slide of this presentation. PMR-SEP-2010-0508 Date of preparation: September 2010 www.uracyst.co.uk Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Definition of PBS/IC* Suprapubic pain related to bladder filling Increased daytime and night-time frequency Absence of infection or other pathology *The ICS reserves the term interstitial cystitis as being a ‘specific diagnosis and requires confirmation by typical cystoscopic features’. Nomenclature Interstitial cystitis Painful Bladder Syndrome PBS/IC Bladder Pain Syndrome Hypersensitive Bladder Syndrome Chronic Pelvic Pain Syndrome Prevalence of PBS/IC Incidence/ 100 000 10 Females 8 Males All patients 6 4 2 0 0-19 20-29 30-39 40-49 50-59 60-69 70-79 Age group, years Age-specific incidence rates for males, females and all patients with interstitial cystitis1 RAND IC Epidemiology Study (RICE) 1. Based on “high sensitivity” definition, 6.5% (95% CI 6.1 – 6.8%) of U.S. women have symptoms of PBS/IC 2. Based on “high specificity” definition, 2.7% (95% CI 2.5 – 2.9%) of U.S. women have symptoms of PBS/IC 3. This translates to between 3,376,317 and 7,851,094 U.S. women age 18 and over with PBS/IC symptoms 4. In the UK this represents approximately 675,500 to 1,600,000 women over the age of 18 years NSO statistics estimate a UK population of just over 25 million females over the age of 18 years http://www.statistics.gov.uk/statbase/Product.asp?vlnk=15106 – Last accessed 6th October 2010 Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Cardinal Symptoms of PBS/IC Pain Frequency Urgency Patient quote “IC affects your family life so much. Even with the simple basic things like taking a shopping trip, you have to realise that you can no longer do what you like, when you like, as you have to plan on finding toilets. My children know that wherever we are ‘Mummy will have to find a toilet soon’.” GALEN WOULD LIKE TO THANK MEMBERS OF THE CYSTITIS AND OVERACTIVE BLADDER FOUNDATION FOR SUPPLYING THESE QUOTES . Patient quote “Having IC has completely changed my working life. I went from working in a full-time, well paid job to being forced to work part-time, local to my home, as I couldn’t travel on public transport anymore.” GALEN WOULD LIKE TO THANK MEMBERS OF THE CYSTITIS AND OVERACTIVE BLADDER FOUNDATION FOR SUPPLYING THESE QUOTES . Patient quote “IC alters your intimate relationships. It’s very difficult to continue to have a fulfilling relationship when you are suffering with so much pain and discomfort.You really do need to have a very understanding partner who realises what you are going through.” GALEN WOULD LIKE TO THANK MEMBERS OF THE CYSTITIS AND OVERACTIVE BLADDER FOUNDATION FOR SUPPLYING THESE QUOTES . Impact on Quality of Life Pain, urinary urgency, and urinary frequency Limitations on Curtailed Sleep Reduced ability sexual intimacy activities deprivation to work Reduced QoL Economic Impact More data is required NHS incurs a considerable cost in treating PBS/IC Clemens et al (US):1 Direct cost per year per patient = $3,631 Indirect cost to the patient per year = $4,216 Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Causes of PBS/IC Irritating solutes GAG layer Urothelium Irritated nerve Inflammation Associated conditions 47% Percentage prevalence IC patients General population 25% 23% 23% 19% 18% 15% 15% 13% 13% 11% 11% 10% 9% 8% 6% 3% 1% Allergy Irritable Sensitive Vulvodynia Fibromyalgia Migraine Asthma Rheumatoid Sjogren's bow el skin arthritis syndrome syndrome Diagnosis Challenges of diagnosis Issues related to the diagnosis of PBS/IC No Restrictive Painful biological research-based invasive markers criteria techniques NIDDK inclusion criteria Bladder pain or urinary urgency Glomerulations or Hunner’s ulcer on cystoscopy Specific findings after hydrodistension Components of basic assessment Medical Urine Symptom History cultures scales Physical Voiding Examination diary Differential diagnosis Urinary Tract Infection Overactive Medication Bladder PBS/IC Bladder Endometriosis Carcinoma Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Management of PBS/IC Diet Oral therapy Intravesical therapy Diet Pharmacological management Epithelial insult More Epithelial inflammation layer damage Antihistamines Anti-inflammatory drugs GAG-like therapies Mast cell Potassium activation; leak into histamine release bladder wall Inhibit neurological Activation of C fibres activity Release of Substance P Oral therapy Amitriptyline Analgesics Antihistamines Anti-inflammatory agents Anticholinergics Oral therapy continued Anticonvulsants Cimetidine Immunosuppressive agents Pentosan polysulfate sodium Intravesical therapy Chondroitin sulfate Sodium hyaluronate Dimethyl sulfoxide Patient perception of intravesical therapy for PBS/IC Total no. of Made Agent Improved No effect patients worse 159/750 59 57 43 DMSO (21.2%) (37.1%) (35.8%) (27.1%) 28/750 15 3 10 Cystistat (3.7%) (53.6%) (10.7%) (35.7%) Heparin 25/750 16 5 4 sodium (3.3%) (64%) (20%) (16%) Surgery Usually last resort Bladder augmentation Urinary diversion Cystectomy Pelvic pain may continue even after the bladder is removed Roadmap What is PBS/IC? Symptoms and impact of PBS/IC Causes and diagnosis of PBS/IC Management of PBS/IC Supporting patients Supporting the patient1 Be understanding of the challenges facing the patient Reassure the patient Explore treatment options Support self-care Uracyst Prescribing Information The full Prescribing Information should be consulted prior to use. Uracyst® Abbreviated Prescribing Information. Description: Each ml of Uracyst contains 20mg sodium chondroitin sulfate (400mg of chondroitin sulfate per 20ml vial). Chondroitin sulfate is an acidic mucopolysaccharide and is one of the glycosaminoglycans (GAGs). The luminal surface of the bladder is coated with a layer of GAGs that provide a protective impermeable barrier to the bladder. Damage to this GAG layer may result in deficiencies to its protective barrier, inducing irritations in the bladder wall. Chondroitin sulfate is an important component of the bladder GAGs that can replenish the deficient GAG layer on the bladder epithelium. Indications: For replenishment of the glycosaminoglycan (GAG) layer in the bladder, for patients with damaged or GAG deficient bladder epithelium. Dosage and administration: Instil 20ml into the bladder after any residual urine has been removed. For optimum results, Uracyst should be used full strength without dilution, and retained in the bladder as long as possible (not less than 30 minutes). Repeat the instillation of 20ml weekly for 4 to 6 weeks, then, monthly thereafter until symptoms are relieved. Most patients benefit from 6 weekly 20ml instillations, then monthly instillations thereafter depending on their symptomatic response. Contraindications: Do not administer to patients with known hypersensitivity to the solution. Warnings: For Bladder Instillation only. Uracyst contains neither preservatives nor antimicrobials; therefore, any unused portion must be discarded. Precautions: Bring the contents of vial to room temperature before use. Adverse effects: No known adverse effects. Short-term discomfort may be caused by the catheterisation process. Legal category: Medical device. CE Number: CE 0473. CE Mark Holder: Stellar Pharmaceuticals Inc, 544 Egerton Street, London, Ontario, Canada N5W 3Z8. Package quantities and price: Single-dose glass vial of 20ml. Packages of four: £260 (UK), €300 (Ireland). Storage: Store 2 to 25oC. Do not freeze. Discard unused portions. Distributed by: Galen Limited. Date of preparation: May 2009. Adverse incidents should be reported. Reporting forms and information can be found at www.mhra.gov.uk or www.imb.ie. Adverse incidents should also be reported to Galen Limited on +44 (0)28 3833 4974 and select the customer services option, or e-mail email@example.com. Medical information enquiries should also be directed to Galen Limited. Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA. Galen Ireland, c/o Allphar Services Ltd, 4045 Kingswood Road, Citywest Business Park, Co Dublin, Ireland. Telephone: +44 (0) 28 3833 4974. Fax: +44 (0) 28 3839 1640. Website: www.galen.co.uk. Email: firstname.lastname@example.org.
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