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INSTYLAN®

INSTYLAN® carton and 50 ml sterile polymer pack with urethral catheter adapter

Urological implants bladder irrigation

An advanced medical device featuring the highest ever Molecular weight Hyaluronic acid for treatment of interstitial Cystitis, Recurrent bacterial cystitis and chemical/ radiation cystitis.

With a molecular weight of 2 million dalton and High Concentration 80mg/50ml to accelerate repair and the NATURAL restoration of the Viscous barrier function of the urinary bladder. Comes in a safe ergonomic sterile polymer pack with a built in urethral catheter adapter that fits easily to any universal catheters.

Interstitial Cystitis / Painful Bladder Syndrome (IC/PBS)

Interstitial cystitis may be related to a loss in the high viscosity glycosaminoglycan (GAG) layer of the urothelium. What is needed is a highly viscous substance that can provide a protective coating and subsequent healing effect. In the absence of bladder enzyme hyaluronidase, it can be expected that high molecular weight HA delivered locally via catheter will be able to reform longer in the bladder and have a sustained and lasting effect.

Three stages of the bladder lining: defective layer, partially reconstructed layer and replenished GAG layer, showing reduced permeability from the coating effect of high molecular weight HA

Regeneration of the mucous membrane of the urinary bladder with INSTYLAN®

  • Hyaluronic acid (HA) located in the basal membrane of cells helps to strengthen the urine and tissue barrier. Unlike surface GAGs which can be washed away with urine, HA creates a more stable permeability barrier.
  • Its large size and unique structure fills the interstitial space, limits mobility and inhibits micro-organisms extension thereby reducing their pathogenicity, and by also facilitating the transport of nutrients promotes the regeneration of the urothelium.
  • The larger size of the hyaluronic acid molecules in INSTYLAN® in comparison with other GAG substitutes, implies a higher efficiency of the barrier function. Low molecular weight fragments of HA have been shown to be present in the urine of patients with interstitial cystitis and have been reported to induce pro-inflammatory cytokines such as IL-12 and TNF-α, and could potentially exacerbate existing inflammation. High molecular weight HA are components of extracellular matrices and are more pro-resolving, shown to decrease secretion of inflammatory cytokines.

Highest Molecular Weight and concentration

95% of patients with chronic cystitis showed pronounced positive clinical dynamics

  • Group 1, n = 10: pain severity before and after INSTYLAN® treatment, severe and intense pain fall sharply, insignificant pain rises
  • Group 2, n = 11: pain severity before and after INSTYLAN® treatment
  • Group 3, n = 9: pain severity before and after INSTYLAN® treatment

INSTYLAN® treatment study on severity of pain syndrome in nosological groups before and after treatment, scores *(p<0.05)1

Quality of Life Index

Index of quality of life from before treatment to week 12: the INSTYLAN® group improves by week 3 and holds, the control group improves less

83% of patients in INSTYLAN® treatment group rated satisfactory Quality of Life (quality of life index L = 2)

Recurrent Urinary Tract Infection

A damaged GAG layer may increase the possibility of bacterial adherence and infection. This damage is proposed to be a causative factor in the development of interstitial cystitis…2 A high molecular weight HA has high electronegativity and provides a better barrier protection.

Urothelial cells 24 hours after UPEC infection: without HA only scattered cells remain, with HA (MW 1500-1800 kDa) the cell monolayer stays intact
Fig 1. 24 hr post-UPEC infection of the urothelia: The monolayer of the HA-treated cells remained intact, suggesting that HA was functioning as a barrier and protecting the urothelium from bacterial adherence, and hence infection3.

Treatment of Hemorrhagic Radiocystitis

  • The best evidence exists for intravesical hyaluronic acid as effective preventative and active treatment of hemorrhagic cystitis (HC).2
  • Loss or defect in the glycosaminoglycan (GAG) layer which coats the uroepithelium is believed to be the first step in the development of HC.6
  • As a result of using INSTYLAN®, bleeding of the bladder wall significantly reduced, the intensity of pelvic pain and the frequency of urgent urination reduced in the absence of adverse reactions.2
“Improvement was generally observed in all patients during treatment, and persisted for 12 months.”
Relief of HC symptoms. Complete remission was defined as the disappearance of all symptoms; Partial response as cessation of blood clot discharges with the preservation of hematuria.
Relief of haemorrhagic cystitis symptoms: complete remission 87.5% and partial 12.5% at 6 months; complete 77% and partial 23% at 12 months
The INSTYLAN® 50 ml pre-filled sterile bag, labelled: 1 a 50 ml pre-filled disposable plastic bag in vacuum packed, 2 the protective connector, 3 the universal nozzle for an urethral catheter, 4 an additional port to add antiseptics, antibiotics, analgesics or hormones
For more information, please visit www.instylan.com.my

Mode of Administration & Treatment Regimen

The course of treatment includes 4 to 12 instillations.

  1. Warm the package to room temperature before use.
  2. Reduce water intake 4 hours before and after administration.
  3. Empty urinary bladder completely.
  4. INSTYLAN® is administered into the cavity of the urinary bladder via a urological catheter; the duration of therapeutic exposure is from 30 minutes to 2 hours.
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INSTYLAN® carton and 50 ml sterile polymer pack with urethral catheter adapter

Video

References:

  1. O.D. Nikitin, The modern approach to intravesical therapy of chronic cystitis. Mens Health NN4 (55) 2015 ISSN 2307-5090
  2. S.P. Pasechnikov Intravesical hyaluronic acid – An effective option in the treatment of hemorrhagic radiocystitis Medical aspects of men’s health No. 1 (20) ‘2016
  3. Stakhovsky E.O. Practical application INSTYLAN® – modern protector of urinary bladder mucosa. National Cancer Institute, Ministry of Health of Ukraine, Kyiv
  4. Lavazzo C, et al., Hyaluronic acid: an effective alternative treatment of interstitial cystitis, recurrent urinary tract infections, and hemorrhagic cystitis? Eur Urol. 2007 Jun;51(6):1534-40; discussion 1540-1. Epub 2007 Mar 20.
  5. Catherine A Mowbray et al., High molecular weight hyaluronic acid: a two-pronged protectant against infection of the urogenital tract? Clinical & Translational Immunology 2018; e1021. doi: 10.1002/cti2.1021
  6. Payne H. et al. “Chemical- and radiation-induced haemorrhagic cystitis: current treatments and challenges BJU international
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