Guidelines for using
Blue Light Cystoscopy with Cysview®

Blue Light Cystoscopy (BLC®) with Cysview is included in Canada, US, and international industry guidelines.

CUA Guidelines (2021):1

  • Patients presenting with a bladder tumour should undergo initial TURBT for diagnostic confirmation and pathological evaluation.
  • TURBT optimization: when available blue light cystoscopy (BLC) can increase tumor detection at first TURBT and reduce recurrence risk.
  • The quality of the initial TURBT is of utmost importance.
 

AUA/SUO Guidelines (2016, Amended 2020):2

  • In a patient with NMIBC, a clinician should offer BLC at the time of TURBT, if available, to increase detection and decrease recurrence. (Moderate Recommendation; Evidence Strength: Grade B)
 

Diagnosis

  • At the time of resection of suspected bladder cancer, a clinician should perform a thorough cystoscopic examination of a patient’s entire urethra and bladder that evaluates and documents tumor size, location, configuration, number, and mucosal abnormalities. (Clinical Principle)
  • At the initial diagnosis of a patient with bladder cancer, a clinician should perform a complete visual resection of the bladder tumor(s), when technically feasible. (Clinical Principle)
  • A clinician should perform upper urinary tract imaging as a component of the initial evaluation of a patient with bladder cancer. (Clinical Principle)
  • In a patient with a history of NMIBC with normal cystoscopy and positive cytology, a clinician should consider prostatic urethral biopsies and upper tract imaging, as well as enhanced cystoscopic techniques (blue light cystoscopy, when available), ureteroscopy, or random bladder biopsies. (Expert Opinion)
 

Risk stratification

  • At the time of each occurrence/recurrence, a clinician should assign a clinical stage and classify a patient accordingly as “low-,” “intermediate-,” or “high-risk.” (Moderate Recommendation; Evidence Strength: Grade C)
 

US Consensus Statement:3

  • Blue Light Cystoscopy with Cysview should be used “at initial TURBT on suspicion of NMIBC.”
  • BLC with Cysview increases tumour detection, which improves intra-operative4 and post-operative5 disease management.

References:

  1. Witjes JA, Babjuk M, Gontero P, et al. Clinical and Cost Effectiveness of Hexaminolevulinate-Guided Blue-Light Cystoscopy: Evidence Review and Updated Expert Recommendations. Eur Urol. 2014;66(5):863-871.
  2. Bhindi B, Kool R, Kulkarni GS, et al. Canadian Urological Association Guideline on the Management of Non-Muscle-Invasive Bladder Cancer – Full-Text. Can Urol Assoc J 2021;15(8): E424-457.
  3. Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016;196(4):1021-1029.
 
 
 

 
 
 
 
 
 

Required Equipment

Approved cystoscopic equipment with necessary filters to allow both White Light Cystoscopy (WLC) and Blue Light Cystoscopy (BLC®) is available in Canada through two manufacturers: KARL STORZ and RICHARD WOLF.

KARL STORZ was the first to provide BLC equipment in Canada. The IMAGE1 S™ Saphira™ system includes a camera-control-unit with camera head and resectoscope with a special light source that supports use of both white and blue light.

 
 
 
 
 

RICHARD WOLF launched its System Blue equipment in 2023. Visualization includes white light mode, bluePDD SIM mode, and bluePDD Color Contrast SIM mode. The camera head generated 4K UHD resolution.

 
 

Reconstitution and Instillation

A Step-By-Step Guide to the Reconstitution and Instillation
of Cysview Using the
Pre-filled Syringe

 
 
 
 
 

This video walks you through the steps of
Cysview reconstitution and instillation.

 
 
 
 
 

For non-muscle invasive bladder cancer Blue Light Cystoscopy with Cysview

This Reconstitution and Instillation guide provides step-by-step instructions for reconstituting and instilling Cysview

English Version:

Order Printed Copies

French Version:

Order Printed Copies

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

When to Use Cysview

Use Blue Light Cystoscopy (BLC®) with Cysview in patients with non-muscle invasive bladder cancer (NMIBC).

Use in first TURBT and the management of intermediate and high-risk patients.

 
 

Consider for patients:

  • At initial TURBT on suspicion of NMIBC
  • Having repeat TURBT
  • Being checked to assess response to BCG therapy 6 weeks after completion
  • Undergoing surveillance
  • Prior to intravesical therapy when the residual disease is suspected, and the patient has not previously had BLC with Cysview
  • With positive cytology and negative White Light Cystoscopy (WLC)
 
 

Guideline and expert consensus recommendations

At initial TURBT on suspicion of NMIBC

AUA/SUO Guideline:

In a patient with NMIBC, a clinician should offer BLC with Cysview, if available, to increase
detection and decrease recurrence. (Moderate Recommendation; Evidence Strength: Grade B).1

 
 
 
 

From Pivotal Clinical Study:

In a prospective, comparative, within-patient controlled, multicenter phase III study in the detection of Ta/T1 tumors in patients who had previously undergone a cystoscopy and had suspicion of or confirmed NMIBC: Out of 286 patients with at least one Ta or T1 tumor, 16% were detected only with BLC with Cysview (p=0.001).2

 
 

2018 Consensus Panel of NMIBC experts:

Strong recommendation to use BLC with Cysview.3

 

During Repeat TURBT

2018 Consensus Panel of NMIBC experts:

BLC with Cysview is strongly recommended in intermediate and high-risk patients.

 

Following treatment with BCG

2018 Consensus Panel of NMIBC experts:

The decision to use BLC with Cysview in this instance should be made on a patient-by-patient basis by taking into account the benefit from accurately diagnosing more clinically significant disease cases versus the risk of false positives. The incidence of false positives decreases as time from BCG therapy increases.4

 
 
 
 
 

2018 Consensus Panel of NMIBC experts:

This scenario is an important endpoint for BLC with Cysview in high-risk patients.3

 
 

In surveillance

2018 Consensus Panel of NMIBC experts:3

For intermediate-risk patients

  • At HCP-determined frequency during surveillance for 2 years
 

For high-risk patients

  • At every other follow-up for 2 years
 
 

Prior to intravesical therapy when residual disease is suspected when the patient has not previously had BLC® with Cysview®

2018 Consensus Panel of NMIBC experts:

A majority of the panel (13/17) thought that BLC with Cysview would be of benefit before initiating intravesical therapy in patients at intermediate risk or high risk of recurrence, based on the patient’s not having undergone a previous TURBT using BLC with Cysview.3

 

When positive cytology and negative WLC

AUA/SUO Guideline:

In patients with a positive cytology and negative WLC, a clinician should consider prostatic urethral biopsies and upper tract imaging, as well as enhanced cystoscopic techniques (BLC, when available), ureteroscopy, or random biopsies. (Expert Opinion).1

 

References:

  1. Chang SS Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016;196(4):1021–1029. Amended 2020.
  2. Stenzl A, Burger M, Fradet Y, et al. Hexaminolevulinate Guided Fluorescence Cystoscopy Reduces Recurrence in Patients with Nonmuscle Invasive Bladder Cancer. J Urol. 2010;184(5):1907–1914.
  3. Lotan Y, Bivalacqua TJ, Downs T, et al. Blue Light Flexible Cystoscopy with Hexaminolevulinate in Non-Muscle Invasive Bladder Cancer: Review of the Clinical Evidence and Consensus Statement on Optimal Use in the USA—Update 2018. Nat Rev Urol. 2019;16(6):377–386.
  4. Daneshmand S, Schuckman AK, Bochner BH, et al. Hexaminolevulinate Blue-Light Cystoscopy in Non-Muscle Invasive Bladder Cancer: Review of the Clinical Evidence and Consensus Statement on Appropriate Use in the USA Nat Rev Urol. 2014;11(10):589–596.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Expert Tips and Experience with Cysview®

Observation

Cause

Solutions

Visual

Resection Management with Blue Light

To avoid false-negative diagnoses

Ensure adequate time after instillation of Cysview

 
 
 
Pink fluorescence on bladder neck should always be seen if the instillation was administered properly

Bladder neck

Fluorescence is considered normal and not necessarily tumour

Want to learn more?

If you’d like more information about how and when to use Cysview, trouble-shooting tips, or anything else, request a visit from your Photocure Key Account Manager. Contact Us

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Indication for Cysview® (hexaminolevulinate HCl)

Cysview is indicated as an adjunct to White Light Cystoscopy in the diagnosis and follow up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection.

Only approved cystoscopic equipment should be used, equipped with necessary filters to allow both White Light Cystoscopy (WLC) and Blue Light (wavelength 360–450nm) fluorescence Cystoscopy (BLC®). Training in Blue Light Cystoscopy with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of Cysview.

 
 

Important Risk & Safety Information

Limitations of Use: Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. 


Contraindications: Cysview is contraindicated in patients with porphyria and/or hypersensitivity to the active substance or to any ingredient in the formulation or component of the container. False-positive fluorescence may result from tangential light, scope trauma from a previous cystoscopic examination, and/or bladder inflammation particularly from intravesical Bacillus Calmette–Guérin (BCG) or chemotherapy treatments. No specific drug interaction studies have been performed. 


Warnings and Precautions: Do not use in patients with gross hematuria. Do not use in patients at high risk of bladder inflammation, e.g., less than 90 days after intravesical BCG or chemotherapy. Do not use for retrograde uretero-renoscopy. Cysview has not been studied in pregnant women or pediatric populations. Cysview may not detect all malignant lesions. Very rare instances of hypersensitivity, including anaphylactic shock, have been reported during post-marketing use of Cysview. Advance life support facilities should be readily available. Biopsy/resect bladder mucosal lesions only following completion of both White Light and Blue Light Cystoscopy. 


Adverse Reactions: Most of the reported adverse reactions in clinical studies were transient and mild or moderate in intensity: bladder spasm 2.0%; dysuria 1.6%; bladder pain 1.4%; and hematuria 1.0%. The adverse reactions observed were expected based on previous experience with standard cystoscopy and TURBT procedures.

 

For additional information about Cysview, please refer to the product monograph.

 
 
 
 

BLC® and Cysview®
are registered trademarks of Photocure ASA.

 

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