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Management of PBS_IC _Painful Bladder Syndrome_Interstitial Cystitis_

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					        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
 info@galen.co.uk. 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: info@galen.co.uk.

				
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