Evidence
and
patient
cases
Cysview® key clinical studies
There are two pivotal studies that show:
Blue Light Cystoscopy (BLC®) with Cysview® improves detection vs. White Light Cystoscopy (WLC) alone in surgery and surveillance1
Stenzl A, et al. – BLC® with Cysview® in the surgery setting2
Study design:
A prospective, multicenter, within-patient controlled, clinical trial in adult patients with known or suspected bladder cancer who were randomized to either WLC (control group, n=384) or WLC followed by BLC (study drug group, n=395).
Only the study drug group patients received Cysview by bladder instillation prior to cystoscopy. After bladder evacuation of Cysview, bladder lesion mapping was performed initially using the KARL STORZ Photodynamic Diagnostic (PDD) system in the white-light mode followed by lesion mapping in the blue-light mode. Control group patients underwent only WLC with lesion mapping.
The study’s primary detection endpoint was the number of patients with histologically confirmed Ta/T1 tumors in the BLC with Cysview group who had at least one additional histologically confirmed Ta/T1 tumor detected with blue but not white light.
Results:
16% of patients had additional Ta/T1 tumors only found with Cysview
Table of results 1
Bladder Tumor Detection within the Study Drug Group by WL and/or BL Cystoscopy1
| Number of lesions | Detected by Both WL & BL | Detected by WL Only | Detected by BL Only |
|---|---|---|---|
| CIS, n = 66 | 33 | 6 | 27 |
| Ta, n = 580 | 472 | 52 | 56 |
| T1, n = 95 | 76 | 10 | 9 |
| T2 - T4, n = 47 | 38 | 8 | 1 |
Among the lesions detected only by BL, 23% were negative for any carcinoma-related pathology, including dysplasia. Among the lesions detected by only WL, 17% were negative for any carcinoma-related pathology, including dysplasia.
Safety considerations from clinical evidence
Risks and adverse effects2
Percent of patients who experienced adverse effects after receiving Cysview
Treatment-related renal and urinary disorders in Cysview patients (n=421)
| Hematuria | 11 | 2.6% |
| Dysuria | 5 | 1.2% |
| Bladder spasm | 4 | 1.0% |
| Bladder retention | 4 | 1.0% |
| Bladder pain | 4 | 1.0% |
Daneshmand S, et al. – BLC® with Cysview® in the surveillance setting3
Study design:
A prospective, open-label, within-patient controlled, clinical trial using BLC with Cysview in the detection of bladder cancer during surveillance cystoscopy. Patients with bladder cancer in follow-up for tumor recurrence (n=304) received Cysview by bladder instillation.
After bladder evacuation of Cysview, a standard WLC was performed, followed by BLC with Cysview using the KARL STORZ D-Light C PDD system with the flexible PDD videoscope system. Suspected malignant lesions were counted and evaluated.
Patients with suspected recurrence (n=103) underwent a Cysview instillation followed by WLC and BLC with Cysview in the OR using the KARL STORZ D-Light C PDD system with the rigid PDD cystoscope system. Lesion mapping was also done. The suspicious lesions were biopsied and surgically removed by TURBT.
The study's primary efficacy endpoint was the proportion of patients with histologically confirmed malignancy that was detected only by BLC and not by WLC during surveillance.
Results:
21% of recurrent patients were only found with Cysview
35% of patients with CIS were only found with Cysview
Table of results 2
Lesion Detection by Type of Malignancy as Verified in the OR
| Malignancy Type | Detected by Both WL & BL | Detected by WL Only | Detected by BL Only |
|---|---|---|---|
| CIS, n = 43 | 24 | 3 | 16 |
| Ta, n = 94 | 61 | 9 | 24 |
| T1, n = 10 | 7 | 0 | 3 |
| T2 - T4, n = 5 | 5 | 0 | 0 |
| PUNLMP** n = 3 | 2 | 0 | 1 |
| False positive n = 160 | 65 | 22 | 73 |
| Total number of lesions | 164 | 34 | 117 |
** papillary urothelial neoplasm of low malignant potential
Safety considerations from clinical evidence
Risks and adverse effects3
Percent of patients who experienced adverse effects after receiving Cysview
Adverse events in Cysview patients at surveillance (n=304)
| Dysuria | 2 | 0.7% |
| Urethral pain | 2 | 0.7% |
| Bladder discomfort | 1 | 0.3% |
| Erythema | 1 | 0.3% |
| Pruritus | 1 | 0.3% |
Case studies
Select an image to enlarge the view below.
Residual tumor
Low-grade Ta
High-grade T1
High-grade papillary
Residual tumor
Patient profile: 69-year-old Caucasian female.
Reason for consultation: Recent diagnosis of Ta urothelial cancer of the bladder.
Status: Post-TURBT at an outside hospital.
Past medical history: Former flight attendant with a history of second-hand smoke exposure.
Previous adjuvant treatments: None.
Indication for TURBT: Evidence of residual disease during Blue Light Cystoscopy (BLC®) with Cysview.
TURBT outcome: TURBT pathology of fluorescing region revealed residual tumor.
Treatment plan: Mitomycin C once a week for eight weeks, followed by cystoscopic re-evaluation.
Cysview may not detect all malignant lesions. False-positive fluorescence may occur due to inflammation, cystoscopic trauma, scar tissue, previous bladder biopsy, recent BCG immunotherapy or intravesical chemotherapy.
Cysview is not a replacement for random biopsies or other procedures used in the detection of bladder cancer. Please see Full Prescribing Information.
For more information review the Important Risk & Safety Information at the bottom of this page.
Video library
Urology expert video vignettes
Showing 3/18 See all
Productivity with Flexible Blue Light Cystoscopy
Dr. Jayram describes his experience with flexible Blue Light Cystoscopy in the office setting and discusses considerations for and benefits of its use.
Tom Jayram, MDTURBT & Risk Categorization with Blue Light Cystoscopy
Dr. Jacob describes his experience with BLC for TURBTs and the impact it can have on patient care.
Joseph Jacob, MDAUA/SUO Guideline Effects
Dr. Steinberg describes the work that was involved in creating the 2016 AUA/SUO Non-Muscle Invasive Bladder Cancer Guideline. He points out several additions and updates that make the guideline more useful in clinical practice. He also discusses some of the specifics around Blue Light Cystoscopy with Cysview in the guideline and in his practice.
Gary Steinberg, MDAUA SUO Guideline Treatment Algorithm
Dr. Steinberg discusses how the AUA/SUO guideline for non-muscle invasive bladder cancer includes a treatment algorithm that outlines steps that urologists can take prior to and following a TURBT to better predict and manage disease progression.
Gary Steinberg, MDAUA SUO Guideline Effects
Dr. O’Donnell explains how the AUA/SUO Guideline is written with the patient in mind. He also discusses how to use the guideline in non-muscle invasive bladder cancer patient care.
Michael O'Donnell, MDEnhanced Cystoscopy Benefits the Patient
Dr. Porten discusses the AUA/SUO guideline for non-muscle invasive bladder cancer and the benefits for patients. She also explains the importance of training residents on how to do a complete resection.
Sima Porten, MDEfficacy and Safety of Flexible BLC with Cysview
The approval of Blue Light Cystoscopy with Cysview in the office setting creates improved opportunity for patient care. In this short video, Dr. O’Donnell discusses the advantages and what patients should ask their urologists. He also shares the impact on his practice, including non-muscle invasive bladder cancer patient types for surveillance using Blue Light Cystoscopy with Cysview.
Michael O'Donnell, MDEfficacy and Safety of Flexible BLC with Cysview
Dr. Daneshmand explains the objectives of the Cysview Flexible Cystoscopy Clinical Study and reports on how they were met. He describes, in detail, how the study was conducted and the resulting data. He also discusses the study results and implications for clinical use with non-muscle invasive bladder cancer patients.
Sia Daneshmand, MDEfficacy and Safety of Flexible BLC with Cysview Pt 1
Dr. Konety describes the Blue Light Cystoscopy with Cysview Prospective Registry Study and its objectives. In addition, he discusses what patients think about Blue Light Cystoscopy with Cysview.
Badrinath Konety, MDEfficacy and Safety of Flexible BLC with Cysview Pt 2
Dr. Konety defines the primary and secondary objectives of the Cysview Flexible Cystoscopy Clinical Study and presents the endpoint data. He also discusses the findings related to repetitive use and safety of Blue Light Cystoscopy with Cysview. In addition, he describes the potential impact of having flexible Blue Light Cystoscopy with Cysview available in the office setting.
Badrinath Konety, MDEfficacy and Safety of Flexible BLC with Cysview
Dr. Steinberg explains the Cysview Flexible Cystoscopy Clinical Study and discusses the resulting data and implications for patient care. He describes the impact of Blue Light Cystoscopy with Cysview related to detection of carcinoma in situ (CIS) and also discusses use of BCG alone in the treatment of CIS. Dr. Steinberg presents the impact of Blue Light Cystoscopy with Cysview on the management of non-muscle invasive bladder cancer patients in the office setting and shares how he uses Blue Light Cystoscopy with Cysview in his practice. He also explains the study data related to false negatives and false positives.
Gary Steinberg, MDThe Role of Repeat TURBT
A TURBT is a visual operation. Dr. Steinberg relates how using white light and blue light with Cysview is almost like the difference between watching TV in black-and-white versus in color and high definition. He also defines use of repeat TURBT.
Gary Steinberg, MDFalse Positive Rates with WLC and BLC with Cysview
Before the introduction of enhanced cystoscopy, the realities about white light false positives were not really considered. Dr. Lotan discusses false-positive rates with both White Light and Blue Light Cystoscopies. He also explains Patient-Reported Outcomes related to a Cysview clinical trial.
Yair Lotan, MDHow I Use BLC with Cysview and Why
Dr. Lotan discusses how he uses Blue Light Cystoscopy with Cysview in his practice for his intermediate and high-risk patients. He also explains how urologists might incorporate guidelines that recommend Blue Light Cystoscopy with Cysview and describes how that practice might benefit non-muscle invasive bladder cancer patients.
Yair Lotan, MDCytology
Historically, cytology was regarded as being highly sensitive for high-grade disease and was used as a back-up to White Light Cystoscopy. In this short video, Dr. Lotan explains how enhanced cystoscopy finds carcinoma that is not indicated by cytology and the resulting impact on use of cytology.
Yair Lotan, MDTrends in Bladder Cancer Management
This is a great time for the field of bladder cancer. Dr. Kamat discusses several developments and their impact on patient care. He also describes the importance of using Blue Light Cystoscopy with Cysview to improve the completeness of TURBTs. In addition, he addresses the topic of BCG-unresponsive disease.
Ashish Kamat, MDBCG and the Role of BLC with Cysview
Dr. Kamat defines the patient types appropriate for BCG treatment and how they might also be appropriate for Blue Light Cystoscopy with Cysview. He describes the best way to incorporate Blue Light Cystoscopy with Cysview in these patients and the critical impact it might have. He also discusses use in both the OR and office settings to deliver personalized patient care.
Ashish Kamat, MDChallenges and Treatment of Unresponsive Disease
It is a big clinical challenge when bladder cancer is unresponsive to BCG treatment. Dr. Kamat presents a short overview on how an incomplete TURBT could be what’s making BCG ineffective.
Ashish Kamat, MDAllied Health Professional videos
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Blue Light Cystoscopy with Cysview: Working with Patients
Tips for Allied Health Professionals
Anne Calvaresi, DNP, CRNP, RNFA from Thomas Jefferson University (Philadelphia, PA) shares her experience with and tips on working with patients undergoing a Blue Light Cystoscopy with Cysview procedure.
Anne Calvaresi, DNP, CRNP, RNFAGetting Started with Rigid Blue Light Cystoscopy with Cysview
Tips for Allied Health Professionals
Tara Cumming, MSN, AGACNP-BC from Texas Urology Group (San Antonio, TX) formerly of Vanderbilt University (Nashville, TN) shares her experience and tips on incorporating the rigid Blue Light Cystoscopy with Cysview procedure into your processes.
Tara Cumming, MSN, AGACNP-BCGetting Started with Flexible BLC
Tips for Allied Health Professionals
Sarah Park, RN, BSN from Atlantic Urology Clinics (Myrtle Beach, SC) shares her experience with getting a urology office ready to offer the flexible Blue Light Cystoscopy with Cysview procedure.
Sarah Park, RN, BSNProcess Tips Related to Flexible Blue Light Cystoscopy with Cysview
Tips for Allied Health Professionals
Sarah Park, RN, BSN from Atlantic Urology Clinics (Myrtle Beach, SC) shares tips on supporting flexible Blue Light Cystoscopy with Cysview procedures in the office setting.
Sarah Park, RN, BSNThird-party videos related to Blue Light Cystoscopy (BLC®) with Cysview®
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Blue Light Cystoscopy with Cysview® in the Surveillance of Bladder Cancer: An Interview with Dr. Siamek Daneshmand
Dr. Sia Daneshmand joins Dr. Ashish Kamat in a conversation about the phase III trial that compared flexible Blue Light Cystoscopy with Cysview with flexible White Light Cystoscopy for the detection of bladder cancer during surveillance. This study showed that Blue Light Cystoscopy with Cysview offers significant improvement in the detection of recurrent bladder cancer and the detection of carcinoma in situ, over White Light Cystoscopy alone.
Blue Light Cystoscopy for Diagnosis of Bladder Cancer – A Journal Club Review by Badrinath Konety
Badrinath Konety, MD, MBA presents key finding from Blue Light Cystoscopy for the diagnosis of bladder cancer: Results from the US prospective multi-center registry published in Urologic Oncology: Seminars and Original Investigations, August 2018. This study evaluated the detection of malignant lesions in patients and documented the change in risk category due to upstaging or upgrading. The authors concluded that Blue Light Cystoscopy with Cysview significantly increases detection rates of CIS and papillary lesions compared to White Light Cystoscopy alone and can result in upstaging or upgrading in about 14% of patients. They also confirmed that repeat use of Cysview is safe.
Blue Light Cystoscopy: What Urologists Want to Know Anne Schuckman, MD
Anne Schuckman, MD, presents the information that supports her decision to use Blue Light Cystoscopy with Cysview in the clinic setting. She takes viewers through the study data and her personal experiences.
Everything You Wanted to Know About Blue Light Cystoscopy with Cysview for Surveillance But Were Afraid to Ask Sia Daneshmand, MD
Dr. Sia Daneshmand discusses use of Blue Light Cystoscopy (BLC) with Cysview in the office/clinic as part of the disease management process. This state-of-the-art procedure started in the operating room using a rigid cystoscope and is now expanding into the office/clinic setting with the approval of Cysvew use with a flexible cystoscope. Dr. Daneshmand focuses on the flex story but also answers questions about his rigid experience as well.
Blue Light Cystoscopy with Cysview for NMIBC: Case Studies and How It Can Change Disease Management Sima Porten, MD
Dr. Sima Porten discusses her experience using Cysview with both flex and rigid cystoscopes in the clinic and OR, respectively. She shares some of her case experiences and discusses how the use of Blue Light Cystoscopy with Cysview has made a difference in the categorization and management of non-muscle invasive bladder cancer. Not only is this state-of-the-art technology helping her current patients, she explains how it is also shaping the care of new patients as well.
Patient and Caregiver Guide to Bladder Cancer
This healthcare segment appeared on the interview TV program called The Balancing Act, which is broadcast on Lifetime TV. It features Dr. Neal Shore of Atlantic Urology Clinic in Myrtle Beach, SC and Cysview Patient Ambassador Cameron Todd from Southern California.
References:
1. Cysview [prescribing information]. 2019:1–4. 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. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018;199(5):1158–1165.