PBS/IC (Painful Bladder Syndrome/Interstitial Cystitis) Unravelling the Enigma PMR-MAY-2009-0239 Date of preparation: May 2009 Slides prepared by Galen Limited as a service to medicine Uracyst® (Chonroitin Sulfate, 2%) Prescribing Information is available on the last slide of this presentation
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PBS/IC (Painful Bladder Syndrome/Interstitial Cystitis) Unravelling the Enigma PMR-MAY-2009-0239 Date of preparation: May 2009 Slides prepared by Galen.
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Patient perception of intravesical therapy for PBS/IC
AgentTotal no. of
patientsImproved
Made worse
No effect
DMSO159/750 (21.2%)
59
(37.1%)
57
(35.8%)
43
(27.1%)
Cystistat28/750 (3.7%)
15
(53.6%)
3
(10.7%)
10
(35.7%)
Heparin sodium
25/750 (3.3%)
16
(64%)
5
(20%)
4
(16%)
Surgery
Usually last resort
Bladder augmentation
Urinary diversion
Cystectomy Pelvic pain may continue even after the bladder is removed
What is PBS/IC?
Symptoms and impact of PBS/IC
Management of PBS/IC
Causes and diagnosis of PBS/IC
Uracyst
Agenda
The role of GAGs
Uracyst
2% solution of sodium chondroitin sulfate
Medical device
Physically restores the GAG layer
Alleviates symptoms, significantly improving patient quality of life
Uracyst may provide the optimum dose of chondroitin sulfate1
Nickel et al 20081
Aim To assess the efficacy and safety of intravesical chondroitin
sulfate (Uracyst) in the treatment of patients with a clinical diagnosis of IC
Method Fifty-three patients with IC were enrolled in a multicentre,
community-based, open-label study, and received intravesical instillations of Uracyst once a week for six weeks, then once a month for 16 weeks
Endpoints The primary endpoint - the percentage of responders to
treatment at week 10*
* assessed by a Global Response Assessment (GRA) scale
Uracyst - 47% response rate after 6 treatments1
53 patients were treated with Uracyst via urinary catheter • Weekly for 6 weeks • Then monthly for 16 weeks*Responders to treatment are indicated by a marked or moderate improvement on a seven-point Global Response Assessment (GRA) scale.
47%
60%
Pe
rce
nta
ge
of
pa
tie
nts
wh
o r
es
po
nd
ed
* to
Ura
cy
st
6 treatments
10 treatments
Uracyst – effectively relieves the symptoms of PBS/IC1
Pain, urgency and frequency were measured using a 0-10cm visual analogue pain scale
0
1
2
3
4
5
6
7
8
9
Pain Urgency Frequency
Mea
n (
SD
) S
core
s
Baseline
6 treatments
10 treatments
n = 53p<0.001
Uracyst – significantly improves patient quality of life1
Symptom and bother scores were measured using the O’Leary-Sant Symptom/Problem Index
0
2
4
6
8
10
12
14
16
Symptom Bother
Mea
n (
SD
) S
core
s
Baseline
6 treatments
10 treatments
n = 53p<0.001
Instillation of Uracyst
Catheter
Uracyst in bladder
Suggested Uracyst treatment plan
Weekly instillations for 4-6 weeks, then monthly thereafter
Optimum response in 4-6 months Revert back to weekly treatment in cases of
symptom flare-up More frequent therapy may be required in patients
with severe PBS/IC No adverse effects are expected with Uracyst2
Pain/discomfort/infection associated with the catheter are possible
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 protected]. Medical information enquiries should also be directed to Galen Limited.