A medical device for the temporary replacement of the glycosaminoglycan (GAG) layer in the bladder. It is indicated for Painful Bladder Syndrome/Interstitial Cystitis (PBS-IC)
Cystistat® is a pioneer in the treatment of Cystitis
Cystistat contains sodium hyaluronate (HA), which is the major component of the protective layer of the bladder. It is a solution that is instilled in a safe and simple procedure directly into the bladder. It acts as a temporary replacement for the defective GAG layer. The GAG layer is deficient in cystitis and Cystistat®alleviates symptoms associated with Painful Bladder Syndrome/Interstitial Cystitis (PBS-IC).
What is Painful Bladder Syndrome/Interstitial Cystitis (PBS-IC)?
Painful Bladder Syndrome/Interstitial Cystitis (PBS-IC), one of the chronic pelvic pain disorders, is a condition resulting in recurring discomfort or pain in the bladder and the surrounding pelvic region. The disease has a significant negative impact on patients’ general lifestyles with frequent need to urinate and chronic pain.
Chronic cystitis is mainly linked to a damaged GAG layer (1)
Changes in the bladder mucosa
What is the GAG layer and what is its function?
There is a protective layer of the bladder, called the glycosaminoglycan (GAG) layer, providing a bio-barrier against microorganisms, carcinogens, crystals and other agents present in the urine. This biofilm, on the inner surface of the bladder wall, is identified as the primary defence mechanism in protecting the transitional epithelium (outermost layer of tissue or organ) from urinary irritants. However, studies show that in PBS-IC patients this protective layer is deficient, allowing substances in the urine to penetrate the bladder wall and trigger PBS-IC symptoms.
Studies show a high response in BPS/IC treatment with Cystistat®
85% of patients observed symptom improvement after initial treatment(2)
Wide range of published papers supporting the treatment of cystitis
- Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)(2)
- Recurrent Bacterial Cystitis (RBC)(5,6)
- Radiation Induced Cystitis (RIC)(7,8)
Why Cystistat®?
- Cystistat® is a high molecular weight HA. High molecular weight HA is capable of binding higher amounts of water compared to low molecular weight HA substitutes
- Cystistat® acts primarily by protecting the bladder barrier. It reduces pain and provides improvement of patient’s quality of life(3)
- Cystistat® has a regenerative role(4); exogenous hyaluronate stimulates endogenous HA synthesis
- Tolerability is confirmed by an extensive clinical experience with more than 1,500,000 instillations worldwide*
References
- Lv YS, et al. Intravesical hyaluronic acid and alkalinized lidocaine for the treatment of severe painful bladder syndrome/interstitial cystitis. International Urogynecology Journal, 23(12), pp.1715-1720, 2012
- 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
- Kallestrup et al. Treatment of interstitial cystitis with Cystistat®: A hyaluronic acid product. Scan J Urol & Neph, 2005; 39:143
- Racine Molecular Regulation of Endocytosis 2012 (Chapter 1)
- Constantinides, C., et al: Preliminary results from the use of HA as a preventative agent for recurrent cystitis in female. BJU Intern., 93: 1262-1266, 2004.
- Vedanayagam, M. et al. The role of hyaluronic acid in the management of uncomplicated recurrent female urinary tract infections: literature review and practical experience. Journal of Clinical Urology, 6(4), pp.243-248, 2013
- Samper P. et al. Vesical instillations of hyaluronic acid to reduce the acute vesical toxicity caused by high-dose brachytherapy do not affect the survival: A five year follow-up study. Clin Transl Oncol 2009; 11:828-834).
- Sommariva et al. Efficacy of sodium hyaluronate in the management of chemical and radiation cystitis. Minerva Urol Nefrol 2010;62:145-50.
*Internal Data – Mylan/Viatris
CONTACT US TODAY