Using
Cysview®
Professional Guidelines
Guidelines recommend using Blue Light Cystoscopy (BLC®) with Cysview1,2
The American Urological Association (AUA)/Society of Urologic Oncology (SUO) state in their joint 2016 guideline (amended 2020):1
"In a patient with NMIBC, a clinician should offer blue light cystoscopy at the time of TURBT, if available, to increase detection and decrease recurrence. (Moderate Recommendation; Evidence Strength: Grade B)."1
AUA/SUO Guideline1
Diagnosis
1“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).”
2“At initial diagnosis of a patient with bladder cancer, a clinician should perform complete visual resection of the bladder tumor(s), when technically feasible. (Clinical Principle).”
3“A clinician should perform upper urinary tract imaging as a component of the initial evaluation of a patient with bladder cancer. (Clinical Principle).”
4“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
5“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).”
National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer (Updated 2023)2
The NCCN Guidelines state:
Enhanced cystoscopy may be helpful in identifying lesions not visible using white light cystoscopy.
Consider enhanced cystoscopy (if available) for initial evaluation or when positive urine cytology.
Required Equipment
Cysview® is FDA-approved for use with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system3
Blue Light Powered by SAPHIRA™
Launched in September 2022, the Blue Light Powered by SAPHIRA™ PDD system offers state-of-the-art image quality and practical features to make the technology more user friendly.
Equipment features and benefits:
Procedure benefits:
Equipment components
To perform Blue Light Cystoscopy (BLC®) with Cysview as an adjunct to White Light Cystoscopy, you will need the KARL STORZ system components listed below.
Support resources
Urologists who perform BLC with Cysview receive training on both the imaging solution and the technology. Staff involved in the process also receive appropriate training.
While there is a learning curve associated with gaining expertise in this technology, there are help and resources always available. Please see below:
The Operating Room Guide
The Operating Room Guide
The Operating Room Guide provides important information on the set-up and use of the non-SAPHIRA™ equipment, including troubleshooting steps.
The PDD Reprocessing Guide
The PDD Reprocessing Guide
The PDD Reprocessing Guide is a quick and easy reference tool for understanding which reprocessing methods are premarket-approved for which PDD-related medical devices.
Reconstitution and instillation
This video walks you through the steps of Cysview reconstitution and instillation.
See our additional resources below:
Hover over materials below to download or order printed copies.
Click materials below to download or order printed copies.
Reconstitution and Instillation Guide
The Reconstitution and Instillation Guide provides step-by-step instructions for reconstituting and instilling Cysview.
Reconstitution Poster
The Reconstitution Poster can hang on your wall to provide easy reference to the step-by-step instructions for reconstituting Cysview.
For questions about or assistance with the Cysview reconstitution and instillation process, speak with your Cysview Account Manager or contact us.
Nurse Support Team for Blue Light Cystoscopy (BLC®) with Cysview®
Photocure: The Bladder Cancer Company has a Nurse Support Team available to respond one-on-one to your individual needs.
You can connect directly with our nurses for help with all your Cysview questions.
The goal of the Cysview Nurse Support Team is to help ensure that you have everything you need to make BLC with Cysview procedures run smoothly at your facility. They are available to answer your questions and patient questions.
Tara CummingMSN, AGACNP-BC
Texas Urology Group
Sarah ParkRN, BSN
Atlantic Urology Clinics
When to use Cysview®
Recommended use cases4-6
Use Blue Light Cystoscopy with Cysview in patients with non-muscle invasive bladder cancer.
Use in first TURBT and the management of intermediate and high-risk patients.
Example use cases from bladder cancer experts consensus publications
Guideline and expert consensus recommendations
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
Pivotal clinical study:
From 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% had additional Ta or T1 tumors only detected with BLC with Cysview (p=0.001).7
2018 Consensus Panel of NMIBC experts:
Strong recommendation to use BLC with Cysview.6
2018 Consensus Panel of NMIBC experts:
BLC with Cysview with either flexible or rigid scope is strongly recommended in intermediate and high-risk patients.6
2014 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.5
2018 Consensus Panel of NMIBC experts:
This scenario is an important endpoint for flexible and rigid BLC with Cysview in high-risk patients.6
Pivotal clinical study:
From a prospective, comparative, open-label, within-patient controlled, multicenter phase III study in the detection of bladder cancer during surveillance (n=63):
At surveillance, 21% of recurrent patients were only found with BLC with Cysview (p<0.0001).8
Cysview® may not detect all bladder tumors and is not a replacement for random biopsies.
2018 Consensus Panel of NMIBC experts:6
For intermediate-risk patients
- At 3-month surveillance with flexible scope
- At HCP-determined frequency during surveillance for 2 years
For high-risk patients
- At 3-month surveillance with flexible scope
- At 6-month follow-up surveillance with flexible scope
- At every other follow-up for 2 years
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.6
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
2018 Consensus Panel of NMIBC experts:
Flexible BLC with Cysview may be used in low, intermediate and high-risk patients. The panel agreed with the AUA/SUO NMIBC Guideline on the need for biopsy, but also considered that flexible BLC could be helpful in determining which operative procedure might be necessary.6
Expert tips and experience with Cysview®
A quick overview of tips and tricks for Blue Light Cystoscopy (BLC®) with Cysview®
Observation | Cause | Solution | Visual | |
|---|---|---|---|---|
| Weak fluorescence | ||||
| No fluorescence | ||||
| Green hue | ||||
| Entire bladder appears red under white and blue light | ||||
| Photobleaching | ||||
| Uncertainty around a large pink/red area | ||||
| Trouble finding orifice or suspicion that orifice might have been resected |
Resection management
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 tumor.
For more information, please access the program below.
Shining a light on Blue Light Cystoscopy with Cysview®: What you need to know
Access this exclusive educational program focusing on the pros and cons of BLC of Cysview for the evaluation, diagnosis, and management of patients with non-muscle invasive bladder cancer (NMBIC).
This program comprises two modules.
Module One:
Blue light vs. White Light Cystoscopy in the Management of Bladder Cancer — An expert roundtable discussion in which our expert panel share their views and experience and present thought-provoking case studies.
Roundtable participants:
- Badrinath Konety, MD, MBA [chair/moderator]
- Sia Daneshmand, MD
- Per-Uno Malmström, MD, PhD
Module Two:
NMIBC: A Patient’s Journey. Introduction to Blue Light Cystoscopy with Cysview with Tips and Tricks — An eSeries presentation featuring a patient case. This multi-modular program offers real-world tips and tricks from experts, delivers comprehensive discussions concerning management of NMIBC, and imparts valuable knowledge, particularly how Cysview integrates into the evaluation, diagnosis, surveillance and follow-up of patients with NMIBC.
Access module two
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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer. Version 3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 28, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 3. Cysview [prescribing information]. 2019:1–4. 4. Witjes JA, Babjuk M, Gontero P, et al. Clinical and Cost Effectiveness of Hexaminolevulinate-Guided Blue-Light Cystoscopy: Evidence Review and Updated Expert Recommendation. Eur Urol. 2014;66(5):863–871. 5. 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. 6. 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. 7. 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. 8. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate (HAL) in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multi-Center Study. J Urol. 2018;199(5):1158–1165.