A medical device for the temporary replacement of the glycosaminoglycan (GAG) layer in the bladder. Cystistat is indicated for Painful Bladder Syndrome/Interstitial Cystitis (PBS-IC).
Cystistat® is a clear colourless solution presented in a 50 ml glass vial containing 40 mg sodium hyaluronate. The glycosaminoglycan (GAG) layer on the luminal surface of the bladder wall is believed to provide a protective barrier against microorganisms, carcinogens, crystals and other agents present in the urine and has been identified as the primary defence mechanism in protecting the transitional epithelium from urinary irritants(1). Deficiencies in this GAG layer of the bladder epithelium may destroy its barrier function and allow the adherence of bacteria, microcrystals, proteins and ions, or the movement of ionic and nonionic solute residues (i.e. urea) across the epithelium(2). Cystistat® has been developed to temporarily replenish the deficient GAG layer on the bladder epithelium. The active substance is a highly purified sodium salt of hyaluronic acid.
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Efficacy and Tolerability is confirmed by a wide clinical experience (5,9)
Cystistat® is Hyaluronic Acid with high molecular weight
How effective is Cystistat®?
- Cystistat® acts primarily by protecting the bladder barrier (3)
- Cystistat® has also a regenerative role (4)
Cystistat® has a wide range of published papers supporting the treatment of cystitis
- Bladder Pain Syndrome / Interstitial Cystitis (BPS / IC) (5)
- Radiation Induced Cystitis (RIC) (6)
- Recurrent Bacterial Cystitis (RBC) (7,8)
Proven significant improvement of patients‘ quality of life (3)
Significant symptom reduction from the primary therapy of Cystistat® (9)
A high response rate was maintained long term with a very good tolerability (5)
50% of the patients may be regarded as cured after only primary therapy of Cystistat® (5)
Cystistat is cost-effective (10)
Pharmacoeconomic evaluation/cost-effectiveness (10)
High Molecular Weight Hyaluronic Acid was significantly superior in cost-effectiveness and cost efficacy to all other instillation regimes (10)
BLADDER PAIN SYNDROME/INTERSTITIAL CYSTITIS (BPS/IC)
The cause of this disorder is still not clear but different hypotheses include subclinical infection, inflammation, mast cell activation and autoimmune mechanisms. BPS/IC is a chronic inflammation of the bladder wall. It is not believed to be caused by bacteria and does not respond to conventional antibiotic treatment. BPS/IC is found in all countries around the world and in all races. It is mainly found in women but many men may in fact be underdiagnosed due to a misdiagnosis.
RECURRENT BACTERIAL CYSTITIS (RBC)
Bacterial cystitis is an inflammation of the bladder caused by bacteria entering the bladder via the urethra. Escherichia Coli are the most common type of bacteria responsible for causing urinary tract infections (UTI). If repeated recurrent bacterial infections occur i.e. one infection every three months or more frequently, this is classed as recurrent bacterial cystitis (RBC).
RADIATION-INDUCED CYSTITIS (RIC)
Haemorrhagic cystitis is a frequent complication in patients receiving Radiation therapy to the pelvic area (radiation-induced cystitis (RIC). Administration of treatments directly into the bladder (e.g. bacillus Calmette-Guérin) Haemorrhagic cystitis has been defined as ‘the presence of sustained haematuria and lower urinary tract symptoms (e.g. dysuria, frequency, urgency) in the absence of active tumour and other conditions’.
References:
- Messing, E.M. Interstitial cystitis and related syndromes, In: Campell’s Urology, 6th edition. Edited by P.C. Walsh, A. B. Retik, T. A. Stamey and E.D. Vaughan, Jr., Philadelphia: W. B. Saunders Co., Vol.1, Sect VII, Chapter 24, pp 982-1005, 1992.
- Parsons, C.L., D. Boychuk, S. Jones, R. Hurst and H. Callahan. Glycosaminoglycans: An Epithelial Permeability Barrier. J.Urol. 143: 139-142, 1990.
- Riedl et al. Hyaluronan treatment of interstitial cystitis/painful bladder syndrome. Int. Urogynecol J Pelvic Floor Dysfunct 2008 May; 19(5): 717-21.
- Searles, J., MacKinnon, A.B.: Effect of sodium hyaluronate bladder irrigation., BJU Intern., 87, Supp.1: 67, 2001.
- Engelhardt P F et al. Long-term results of intravesical hyaluronan therapy in bladder pain syndrome/interstitial cystitis. Int Urogynecol J. 2011 Apr;22(4):401-5.
- Sommariva et al. Efficacy of sodium hyaluronate in the management of chemical and radiation cystitis. Minerva Urol Nefrol 2010;62:145-50.
- Constantinides et al. Prevention of recurrent bacterial cystitis by intravesical administration of hyaluronic acid: a pilot study, 2004, BJU International, 93, 1262: 1266.
- Vedanayagam M, et al. The role of hyaluronic acid in the management of uncomplicated recurrent female urinary tract infections: literature review and practical.
- Kallestrup et al. Treatment of interstitial cystitis with Cystistat: A hyaluronic acid product. Scan J Urol & Neph, 2005; 39:143.
- Barua et al. A systematic review and meta-analysis on the efficacy of intravesical therapy for BPS/IC. Int Urogynecol J (2015).
**Internal data
***Quality of Life
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