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Guidelines

Health Care Professionals

Guidelines

Acknowledged by
Prominent Organizations

The clinical value of Blue Light Cystoscopy with Cysview® (BLC™ with Cysview®) has been included in several national and international guidelines as being more sensitive than conventional white light cystoscopy for detecting tumors.

American Urological Association (AUA)/Society of Urologic Oncology (SUO) (2016)17

Principles of the Guidelines

  • 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 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)
  • Incomplete transurethral resection of bladder tumor (TURBT) is likely a significant contributing factor to early bladder cancer recurrences, as tumors are seen at first surveillance cystoscopy in up to 45 percent of patients.
  • 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)

AUA Risk Stratification System

Low Risk

Intermediate Risk

High Risk

LGa solitary Ta ≤ 3cm
Recurrence within 1 year, LG Ta
HG T1
PUNLMPb
Solitary LG Ta > 3cm
Any recurrent, HG Ta
LG Ta, multifocal
HG Ta, >3cm (or multifocal)
HGc Ta, ≤ 3cm
Any CISd
LG T1
Any BCG failure in HG patient
Any variant histology
Any LVIe
Any HG prostatic
urethral involvement
aLG = low grade; bPUNLMP = papillary urothelial neoplasm of low malignant potential; cHG = high grade; dCIS = carcinoma in situ; eLVI = lymphovascular invasion

Enhanced Cystoscopy

In a patient with non-muscle invasive bladder cancer (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)

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Modified Image

Diagnosis

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)

BLC with Cysview helps your facility implement the new AUA/SUO guidelines and improve NMIBC detection, which leads to more thorough resection. Complete TURBT is critical in NMIBC management for accurate tumor type, staging, grading and optimization of patient outcomes.

An incomplete TURBT can lead to understaging, misdiagnosis and incomplete resection; over-reliance on intravesical therapy may lead to less optimal treatment, worse outcomes and increased costs for patients. TURBT procedures with BLC with Cysview have been shown to increase diagnostic accuracy and optimize patient care management decisions.

Watch the presentation of the updated AUA/SUO guidelines announcement at AUA 2016, and then download the guidelines for your facility.

National Comprehensive Cancer
Network (NCCN) (2016)

Use of BLC with Cysview is recommended (category 2A) for transurethral resection (TUR) for papillary appearing tumors and suspected or known carcinoma in situ (CIS).18

Existing European Guidelines and consensus statements on the use of BLC

Prescribing Information

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLCTM) as an adjunct to the white light cystoscopy.

Important Safety Information About Cysview® (hexaminolevulinate HCl)

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

Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain. 

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Cysview may fail to detect some malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy and recent BCG therapy or intravesical chemotherapy. No specific drug interaction studies have been performed. 

Safety and effectiveness have not been established in pediatric patients. There are no available data on Cysview use in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal. There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cysview and any potential adverse effects on the breastfed infant from Cysview or from the underlying maternal condition. 

Cysview is approved for use with the KARL 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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Prescribing Information

Cysview is an optical imaging agent indicated for use in the cystoscopic detection of carcinoma of the bladder, including carcinoma in situ (CIS), among patients suspected or known to have lesion(s) on the basis of a prior cystoscopy, or in patients undergoing surveillance cystoscopy for carcinoma of the bladder. Cysview is used with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system to perform Blue Light Cystoscopy (BLCTM) as an adjunct to the white light cystoscopy.

Important Safety Information About Cysview® (hexaminolevulinate HCl)

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

Anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain. 

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid. Cysview may fail to detect some malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy and recent BCG therapy or intravesical chemotherapy. No specific drug interaction studies have been performed. 

Safety and effectiveness have not been established in pediatric patients. There are no available data on Cysview use in pregnant women. Adequate reproductive and developmental toxicity studies in animals have not been performed. Systemic absorption following administration of Cysview is expected to be minimal. There are no data on the presence of hexaminolevulinate in human or animal milk, the effects on a breastfed infant, or the effects on milk production. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cysview and any potential adverse effects on the breastfed infant from Cysview or from the underlying maternal condition. 

Cysview is approved for use with the KARL 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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