Cystoscopy

A cystoscope is a specialized endoscope allowing for direct visual inspection of the urothelium. The cystoscope is inserted through the urethra into the bladder. The endoscopy can be performed immediately after the cystoscope has been introduced into the bladder and the pictures generated by the integrated camera are transmitted onto a nearby video screen. Cystoscopy can be performed with a local anaesthetic - usually for outpatients - and under general anaesthesia. Most cystoscopes have extra tubes to guide other instruments for taking a biopsy of a bladder tumor or removal of non-muscle invasive bladder tumors. 

There are two different types of cystoscope; the standard rigid cystoscope and the flexible cystoscope.  The three major manufacturers of cystoscopes and cystoscopy equipment are Olympus, KARL STORZ, and Richard Wolf. All three provide the necessary equipment for both standard white light cystoscopy, however, only KARL STORZ has a bluelight PDD system approved in the US1

Standard White Light Cystoscopy 
Standard white light cystoscopy is used in the diagnosis and monitoring of bladder cancer. Illumination for standard white light cystoscopy is provided by special light sources integrated with the cystoscope, which emit bright, white light. Cystoscopy-guided biopsy, ie, transurethral resection (TUR) of suspicious lesions and areas, remains the standard procedure for verification of bladder cancer.

Visual inspection using standard white light cystoscopy is particularly good at detecting large three-dimensional, ie, papillary, lesions.

Cysview Blue Light Cystoscopy
In order to assist the early and accurate diagnosis of bladder cancer, methods to improve cystoscopy such as fluorescence cyctoscopy have been investigated. Intravesical porphyrin-based fluorescence cystoscopy involves instilling a photosensitising agent - such as Cysview - into the bladder.  Cysview induces preferential accumulation of fluorescent - photoactive - endogenous porphyrins in malignant cells as opposed to nonmalignant cells of urothelial origin.  Under subsequent blue-light illumination, neoplastic lesions fluoresce red, enabling visualisation of tumors.2,3  Significant improvements in detection of malignant lesions with Cysview Blue Light cystoscopy compared to standard white light cystoscopy have been observed.4  Overall, Cysview Blue Light cystoscopy shows a statistically significant superiority over white light cystoscopy regarding sensitivity for the detection of papillary lesions.3,4,5

“Cysview Bluelight cystoscopy is a new diagnostic tool with improved sensitivity for detecting bladder tumors [over standard white light cystoscopy]. 


References

  1. Klem B. Cysview Bluelight cystoscopy - equipment needed. Cysview Product Monograph:31. 
  2. Frampton JE, Plosker GL. Hexyl Aminolevulinate in the Detection of Bladder Cancer. Drugs 2006;66:571-8. 
  3. Schmidbauer J, Witjjes F, Schmeller N et al. Improved Detection of Urothelial Carcinoma In Situ with Hexaminolevulinate Fluorescence Cystoscopy. J Urol 2004;171:135-8. 
  4. Jocham D, Witjes F, Wagner S et al. Improved Detection and Treatment of Bladder Cancer Using Hexaminolevulinate Imaging: A Prospective, Phase III Multicenter Study. J Urol 2005;174:862-6. 
  5. Jichlinski P, Guillou L, Karlsen SJ et al. Hexyl Aminolevulinate Fluorescence Cystoscopy: A New Diagnostic Tool for the Photodiagnosis of Superficial Bladder Cancer - A Multicenter Study. J Urol 2003;170:226-9. 
  6. van der Meijden APM, Sylvester R, Oosterlink W et al. EAU Guidelines on the Diagnosis and Treatment of Urothelial Carcinoma in Situ. Eur Urol 2005;48:363-71. 
     

Licensed from Photocure ASA. 
Cysview is a trademark of Photocure ASA. 


Scan courtesy of Dirk Zaak, Associate Professor, 
Dept. of Urology, University of Munich, Germany.

 
View of bladder with white light cystoscope followed by view of bladder with blue light
cystoscope
Photo credit - Dr. Maximilian Burger, University of
Regensburg
 

Indications and Usage

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of non-muscle invasive  papillary cancer of the bladder among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.  Cysview is used with the KARL STORZ  D-Light C Photodynamic Diagnostic (PDD)™ system to perform cystoscopy with the blue light setting (Mode 2) as an adjunct to the white light setting (Mode 1).

Cysview is not for repetitive use and is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer.


Product Risk Information:

Safety and effectiveness have not been established in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue light cystoscopy, nor in pediatric patients.

The following adverse reactions have been identified during post-approval use of Cysview. Because these reactions are reported voluntarily
from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cases of anaphylactoid shock, bladder pain, cystitis and abnormal urinalysis have uncommonly been reported.

Cysview should not be used in patients with porphyria or with known hypersensitivity to hexaminolevulinate. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed.
 
Cysview must be used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the Karl Storz instruction manuals for each of the components.

 

Prior to Cysview administration, read the Full Prescribing Information and follow the preparation and reconstitution instructions.

 

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