Follow-up Of Non-muscle Invasive Bladder Cancer Research Articles

Photodynamic cystoscopy for bladder cancer diagnosis and for NMIBC follow-up: An overview of systematic reviews and meta-analyses

Currently, bladder cancer detection is based on cytology and cystoscopy. White light cystoscopy (WLC) is an invasive procedure and may under-detect flat lesions. Blue light cystoscopy (BLC) and narrow band imaging (NBI) cystoscopy are new modalities that could improve the detection of non-muscle invasive bladder cancer (NMIBC) and its recurrence or progression to muscle invasive bladder cancer. We present a systematic review on BLC and NBI cystoscopy for bladder cancer diagnosis and NMIBC follow-up. All available systematic reviews and meta-analyses on cystoscopy published in PubMed® between May 2010 and March 2021 were identified and reviewed. The main endpoints were clinical performance for bladder cancer diagnosis and for recurrence or progression detection during NMIBC follow-up, and additional value compared with cytology and/or WLC. Most of the meta-analyses and systematic reviews published suggest a better sensitivity of BLC and NBI cystoscopy compared to WLC, particularly for the detection of flat lesions (CIS). NBI- and BLC-guided TURBT could decrease the recurrence rates. However, their clinical utility to reduce progression rate and increase survival is still unclear. BLC and NBI cystoscopy are efficient techniques for bladder cancer diagnosis and NMIBC follow-up. However, their clinical benefit remains to be confirmed.

MP08-04 USE OF ANTIBIOTICS IN PATIENTS UNDERGOING FOLLOW-UP FOR NON-MUSCLE INVASIVE BLADDER CANCER WITH EITHER FLEXIBLE CYSTOSCOPY OR THE URINARY BIOMARKER TEST XPERT® BLADDER CANCER MONITOR: A SECONDARY OUTCOME FROM A RANDOMISED CLINICAL TRIAL

You have accessJournal of UrologyCME1 Apr 2023MP08-04 USE OF ANTIBIOTICS IN PATIENTS UNDERGOING FOLLOW-UP FOR NON-MUSCLE INVASIVE BLADDER CANCER WITH EITHER FLEXIBLE CYSTOSCOPY OR THE URINARY BIOMARKER TEST XPERT® BLADDER CANCER MONITOR: A SECONDARY OUTCOME FROM A RANDOMISED CLINICAL TRIAL Thomas Dreyer, Simone Brandt, Knud Fabrin, Nessn Azawi, Juan Luis Vásquez, Andreas Ernst, Lars Dyrskjøt, and Jørgen Bjerggaard Jensen Thomas DreyerThomas Dreyer More articles by this author , Simone BrandtSimone Brandt More articles by this author , Knud FabrinKnud Fabrin More articles by this author , Nessn AzawiNessn Azawi More articles by this author , Juan Luis VásquezJuan Luis Vásquez More articles by this author , Andreas ErnstAndreas Ernst More articles by this author , Lars DyrskjøtLars Dyrskjøt More articles by this author , and Jørgen Bjerggaard JensenJørgen Bjerggaard Jensen More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003223.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with non-muscle-invasive bladder cancer (NMIBC) have a high recurrence rate, which leads to frequent flexible cystoscopies (FC). Aside from the burden of undergoing FC, there is a risk of urinary tract infection (UTI) following FC. Follow-up of NMIBC with non-invasive urinary biomarker tests could reduce the number of FCs, and thus potentially the need for antibiotics due to UTI. Furthermore, because UTIs are among the most common infections, any reduction in incidence could reduce development of multiresistant uropathogenic bacteria.In this study, a secondary outcome from the DaBlaCa-15 trial is reported. The objective was to compare the number of patients with collected prescriptions for antibiotics for UTI in patients followed with FC versus patients followed primarily with the urinary biomarker test Xpert® Bladder Cancer Monitor (XBCM) (CE-IVD. In Vitro Diagnostic Medical Device. May not be available in all countries. Not available in the United States.). METHODS: A two-arm randomised non-inferiority trial enrolling 392 patients with previous high-grade NMIBC was conducted. In the intervention arm, patients were followed with XBCM every four months with only one yearly pre-scheduled FC. Patients in the control arm underwent FC every four months for two years. The number of patients who collected prescriptions for UTI during the study period was compared both peri- and post-FC and for visits where a FC was not pre-scheduled. RESULTS: During follow-up, 23.7% of patients in the intervention arm collected a prescription compared to 31.0% in the control arm (RR 0.76; 95% CI 0.55-1.06; p=0.11). When analysing visits without a pre-scheduled FC, 6.3% of patients in the intervention arm collected a prescription in the 14 days after a visit versus 13.4% in the control arm (RR 0.47; 95% CI 0.25-0.90; p=0.02). Similarly, the peri-FC use of antibiotics was 7.9% in the intervention arm, compared to 15.0% in the control arm (RR 0.53; 95% CI 0.29-0.94; p=0.03). A reduction in the number of FCs performed in the intervention arm was observed (39.1% versus 98.3%; p<0.0001). CONCLUSIONS: The findings of the present study support the hypothesis that replacing cystoscopy with XBCM can reduce the use of antibiotics for UTI during follow-up of NMIBC. Thus, the morbidity of follow-up of NMIBC with FC can be reduced, resulting perhaps in less development of multiresistant uropathogenic bacteria and increased quality of life. Source of Funding: Supported by Cepheid Inc. © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e94 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Thomas Dreyer More articles by this author Simone Brandt More articles by this author Knud Fabrin More articles by this author Nessn Azawi More articles by this author Juan Luis Vásquez More articles by this author Andreas Ernst More articles by this author Lars Dyrskjøt More articles by this author Jørgen Bjerggaard Jensen More articles by this author Expand All Advertisement PDF downloadLoading ...

Adherence to guidelines in the follow-up of non-muscle-invasive bladder cancer among urology trainers and trainees in Jordan: a cross-sectional study.

An electronic questionnaire containing, in addition to demographic data, four questions regarding the follow-up of NMIBC was sent by e-mail to 115 urologists (53 residents and 62 specialists) selected randomly by stratified random sampling from different clinical institutions, 105 of them were returned complete. In all, 105 out of 115 (91%) questionnaires were returned complete. All of the candidates are male. For low-risk NMIBC follow-up, 46 of the specialists (79%) and 35 of the trainees (74%) decided to do a follow-up cystoscopy at 3 months after diagnosis, followed by a check cystoscopy 9 months later than yearly, while for high-risk patients, all of the specialists and 45 of the trainees (96%) decide to do a check cystoscopy every 3 months in the first 2 years after diagnosis. For upper tract follow-up in high-risk NMIBC, all of the urologists in the survey (specialists and trainees) routinely perform upper tract imaging in the form of a computed tomography scan with contrast in the first year after diagnosis. On the other hand, in the follow-up of the upper urinary tract in low-risk NMIBC, 16 of the trainees (34%) and 19 of the specialists (33%) still perform a yearly scan. Because of the high recurrence rate for NMIBC, this raises the importance of adherence to guidelines in the follow-up for these patients and, at the same time to avoid overdoing unnecessary cystoscopies or upper tract scans.

Bladder EpiCheck urine test in the follow-up of NMIBC: a cost analysis.

In the Netherlands yearly more than 5000 patients are diagnosed with non-muscle invasive bladder cancer (NMIBC). With a specificity of 88.0% and a negative predictive value (NPV) for high grade NMIBC of 99.3%, the Bladder EpiCheck (BE) urine test may be used in NMIBC to reduce the burden of follow-up cystoscopies. In this study a cost analysis of the BE follow-up strategy in the Dutch healthcare system was performed. In half of the follow-up appointments, BE was used as a rule-in for cystoscopy. In addition, the possible delay in recurrence detection was estimated. A cost calculation tool was developed using Microsoft Excel. The BE strategy results in an estimated cost reduction of 8%, 4% and 9% in low, intermediate and high risk patients, respectively. In the Netherlands this may result in a cost reduction of approximately 1.6 million euro per year. The estimated delay in the detection of recurrent disease would be 3.9, 1.7 and 1.3months in low, intermediate and high risk NMIBC patients respectively. To conclude, the BE can be used to reduce the costs of NMIBC follow-up, with a small delay in diagnosis of recurrent disease.

Noninvasive studies may have potential to replace cystoscopy in non-muscle invasive bladder cancer follow-up

Bladder cancer has a high recurrence rate which requires frequent follow-up. Cystoscopy is currently the gold standard for follow-up which is invasive and undesirable procedure for patients. We aimed to investigate the feasibility of noninvasive studies for follow-up of non-muscle invasive bladder cancer. This retrospective study was done for non-muscle invasive bladder cancer patients with abnormal lesion at follow up cystoscopy, therefore those needed transurethral resection of bladder tumor (TUR-BT). Inclusion criteria was patients who had preoperative bladder magnetic resonance imaging (MRI) within 1 month to TUR-BT and urine cytology results. MRI, urine cytology, and surgical pathology results were analyzed for sensitivity, specificity, positive and negative predictive values, accuracy, diagnostic odds ratio, and number needed to misdiagnose for the diagnostic performance of non-invasive studies. From total of 2,258 TUR-BT cases, 1,532 cases of primary TUR-BT and 481 cases which bladder MRI were not done was excluded. Finally, 245 cases of TUR-BT were included. Combined urine cytology and bladder MRI showed 96% sensitivity, 43% specificity, 89% positive and 67% negative predictive values, 87% accuracy, 16.2 diagnostic odds ratio, and 7.4 number needed to misdiagnose values. Among nine false-negative cases, three (1.2%) were missed by the radiologist, two (0.8%) had an empty bladder during magnetic resonance imaging, and three (1.2%) had gross hematuria which needed cystoscopy despite of bladder MRI or urine cytology result. Only one case (0.4%) was missed based on symptoms and noninvasive tests. However, none of the false-negative cases showed rapid extensive progression requiring radical or partial cystectomy. The combination of bladder MRI and urine cytology was comparable to cystoscopy for the follow-up of recurred lesions in non-muscle invasive bladder cancer patients for sensitivity, but not for specificity. However, it may reduce the need for cystoscopy and allowing patients to have choices for follow up diagnostic methods. Also, additional imaging tests to evaluate kidney, ureter and peri-vesical lesions can be reduced.

Optimizing treatment for non muscle-invasive bladder cancer with an app

ObjectivesTo evaluate overall and recurrence-progression rate-adjusted concordance of treatment prescription in non-muscle-invasive bladder cancer (NMIBC) of an app based on the best available scientific evidence and the urologist's opinion. MethodsDevelopment of an app (APPv) specifically designed for the treatment and follow-up of NMIBC and validation of the proposed APPv treatment endpoint by means of a prospective double-blind observational concordance study of related samples in 100 patients with initial or successive histological diagnosis of NMIBC. ResultsThe treatment prescribed by the urologist agrees with that proposed by the APPv in 64% of cases (kappa index 0.55, P < 0.0001). Regarding low risk, the agreement is 77% (kappa 0.55, P = 0.002), 63% (kappa 0.52, P < 0.0001) for intermediate risk, 17% (kappa 0.143, P = 0.014) in high risk and 66% (kappa 0.71, P = 0.01) for very high risk. Of patients receiving adjuvant intravesical treatment according to APPv, 89.1% remain free of recurrence vs. 61.1% of those with disagreement (P = 0.0004), with a RR 0.46 (95%CI: 0.25-0.86) vs. RR 2.4 (95%CI: 1.5-3.8, P = 0.001). In the APPv-urologist agreement group, 100% of patients are free of progression and 88.9% in the disagreement group (P = 0.004) with a RR 1 vs. RR 1.125 (95%CI: 1-1.26, P = 0.004). ConclusionsAPPv can improve adherence to treatment recommendations according to clinical practice guidelines and health outcomes at NMIBC.

Optimización del tratamiento del cáncer de vejiga no músculo invasivo mediante una app

ObjectivesTo evaluate overall and recurrence-progression rate-adjusted concordance of treatment prescription in non-muscle-invasive bladder cancer (NMIBC) of an app based on the best available scientific evidence and the urologist's opinion. MethodsDevelopment of an app (APPv) specifically designed for the treatment and follow-up of NMIBC and validation of the proposed APPv treatment endpoint by means of a prospective double-blind observational concordance study of related samples in 100 patients with initial or successive histological diagnosis of NMIBC. ResultsThe treatment prescribed by the urologist agrees with that proposed by the APPv in 64% of cases (kappa index 0.55, P<0.0001). Regarding low risk, the agreement is 77% (kappa 0.55, P=0.002), 63% (kappa 0.52, P<0.0001) for intermediate risk, 17% (kappa 0.143, P=0.014) in high risk and 66% (kappa 0.71, P=0.01) for very high risk. Of patients receiving adjuvant intravesical treatment according to APPv, 89.1% remain free of recurrence vs. 61.1% of those with disagreement (P=0.0004), with a RR 0.46 (95%CI: 0.25-0.86) vs. RR 2.4 (95%CI: 1.5-3.8, P=0.001). In the APPv-urologist agreement group, 100% of patients are free of progression and 88.9% in the disagreement group (P=0.004) with a RR 1 vs. RR 1.125 (95%CI: 1-1.26, P=0.004). ConclusionsAPPv can improve adherence to treatment recommendations according to clinical practice guidelines and health outcomes at NMIBC.

Assessment of Xpert Bladder Cancer Monitor test performance for the detection of recurrence during non-muscle invasive bladder cancer follow-up

PurposeTo assess the performance of the Xpert Bladder Cancer (BC) Monitor during the follow-up of patients with non-muscle invasive bladder cancer (NMIBC).MethodsPatients with previously diagnosed NMIBC and followed up in clinical practice settings in two French urology departments between September 2017 and July 2019 were consecutively enrolled in this prospective observational study. Patients with a positive cystoscopy or computed tomography urogram underwent subsequent transurethral resection of the bladder, and/or biopsy, and the specimens were pathologically assessed. Cytology and Xpert BC Monitor tests were performed on urine samples. Xpert BC Monitor performance was assessed versus cystoscopy for disease-negative patients or versus histology for disease-positive patients, and was compared to that of cytology.ResultsOverall, 500 patients with a median age of 70.0 years were included. NMIBC recurrence was diagnosed in 44 cases (8.8%). Overall sensitivity, specificity, and negative predictive values (NPVs) were 72.7% (32/44), 73.7% (330/448) and 96.5% (330/342) for the Xpert BC Monitor, and 7.7% (2/26), 97.8% (310/317) and 92.8% (310/334) for cytology, respectively. The Xpert BC Monitor detected 92.3% (12/13) of the high-grade tumours and ruled out their presence in 99.7% (330/331) of cases. Analysis of the areas under the receiver operating characteristic curves demonstrated the superior performance of the Xpert BC Monitor over that of cytology.ConclusionXpert BC Monitor performance was superior to that of cytology in the follow-up of NMIBC. The exclusion of aggressive tumours with a very high NPV (99.7%) supports the use of this urinary test in daily practice.

Developments in the follow-up of nonmuscle invasive bladder cancer

Purpose of review Patients with nonmuscle invasive bladder cancer (NMIBC) have a high risk of recurrent tumors, even in spite of contemporary guideline recommended therapy. Follow-up recommendations are also clear (cystoscopy with cytology and upper urinary tract imaging in high-risk patients), but frequency and duration of follow-up are well defined. However, recent developments in follow-up tools might be of interest for clinical practice. Recent findings Enhanced endoscopy improves detection and treatment of recurrences, and it can help in tailoring follow-up. However, it remains an invasive procedure. Most recently cystoscopy augmented with artificial intelligence has shown some promising results. Active surveillance, frequently done in prostate cancer patients, is also gaining attention in NMIBC follow-up. Finally markers are being studied and launched. Although not recommended by guidelines, and not used in clinical practice, recent studies have shown marker combinations with very high negative predictive values for (high risk) recurrences in follow-up of NMIBC patients. Summary New tools for follow-up such as enhanced cystoscopy and urinary markers might help to individualize follow-up, which will result in decreasing patient discomfort, workload and costs while quality of care is maintained.

Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Nonmuscle Invasive Bladder Cancer Followup: A Blinded, Prospective Cohort, Multicenter European Study.

Detection of MCM5 containing cells in urine has been shown to be indicative of the presence of a bladder tumor on primary diagnosis. In this study we evaluate diagnostic performance of ADXBLADDER in patients undergoing cystoscopic surveillance in nonmuscle invasive bladder cancer followup. A multicenter prospective blinded study was performed at 21 European centers with patients undergoing cystoscopy for nonmuscle invasive bladder cancer surveillance, diagnosed in the preceding 2 years. Urine was collected from all eligible patients and ADXBLADDER-MCM5 testing was performed. Performance characteristics were calculated by comparing MCM5 results to the outcome of cystoscopy plus pathological assessment. Of 1,431 eligible patients enrolled 127 were diagnosed with a bladder cancer recurrence. The overall sensitivity for the ADXBLADDER-MCM5 test in detecting bladder cancer recurrence was 44.9% (95% CI 36.1-54) with a 75.6% sensitivity for nonpTaLG tumors (95% CI 59.7-87.6). Specificity was 71.1% (95% CI 68.5-73.5). The overall negative predictive value was 93% (95% CI 91.2-94.5). However, ADXBLADDER was able to rule out the presence of a nonpTaLG recurrent tumor with a negative predictive value of 99.0% (95% CI 98.2-99.5). No statistically significant differences in the performance of ADXBLADDER were observed as a result of age or sex. This large blinded prospective study demonstrates that in the followup of patients with nonmuscle invasive bladder cancer ADXBLADDER is able to exclude the presence of the most aggressive tumors with a negative predictive value of 99%. These results indicate that ADXBLADDER could be incorporated in the followup strategy of nonmuscle invasive bladder cancer.

Validation of a Novel, Sensitive, and Specific Urine-Based Test for Recurrence Surveillance of Patients With Non-Muscle-Invasive Bladder Cancer in a Comprehensive Multicenter Study.

Bladder cancer (BC), the most frequent malignancy of the urinary system, is ranked the sixth most prevalent cancer worldwide. Of all newly diagnosed patients with BC, 70–75% will present disease confined to the mucosa or submucosa, the non-muscle-invasive BC (NMIBC) subtype. Of those, approximately 70% will recur after transurethral resection (TUR). Due to high rate of recurrence, patients are submitted to an intensive follow-up program maintained throughout many years, or even throughout life, resulting in an expensive follow-up, with cystoscopy being the most cost-effective procedure for NMIBC screening. Currently, the gold standard procedure for detection and follow-up of NMIBC is based on the association of cystoscopy and urine cytology. As cystoscopy is a very invasive approach, over the years, many different noninvasive assays (both based in serum and urine samples) have been developed in order to search genetic and protein alterations related to the development, progression, and recurrence of BC. TERT promoter mutations and FGFR3 hotspot mutations are the most frequent somatic alterations in BC and constitute the most reliable biomarkers for BC. Based on these, we developed an ultra-sensitive, urine-based assay called Uromonitor®, capable of detecting trace amounts of TERT promoter (c.1-124C > T and c.1-146C > T) and FGFR3 (p.R248C and p.S249C) hotspot mutations, in tumor cells exfoliated to urine samples. Cells present in urine were concentrated by the filtration of urine through filters where tumor cells are trapped and stored until analysis, presenting long-term stability. Detection of the alterations was achieved through a custom-made, robust, and highly sensitive multiplex competitive allele-specific discrimination PCR allowing clear interpretation of results. In this study, we validate a test for NMIBC recurrence detection, using for technical validation a total of 331 urine samples and 41 formalin-fixed paraffin-embedded tissues of the primary tumor and recurrence lesions from a large cluster of urology centers. In the clinical validation, we used 185 samples to assess sensitivity/specificity in the detection of NMIBC recurrence vs. cystoscopy/cytology and in a smaller cohort its potential as a primary diagnostic tool for NMIBC. Our results show this test to be highly sensitive (73.5%) and specific (93.2%) in detecting recurrence of BC in patients under surveillance of NMIBC.

Performance of the Bladder EpiCheck™ Methylation Test for Patients Under Surveillance for Non–muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial

BackgroundThe highly frequent strategy of surveillance for non–muscle-invasive bladder cancer (NMIBC) involves cystoscopy and cytology. Urine assays currently available have not shown performance sufficient to replace the current gold standard for follow-up, which would require a very high negative predictive value (NPV), especially for high-grade tumors. Bladder EpiCheck (BE) is a novel urine assay that uses 15 proprietary DNA methylation biomarkers to assess the presence of bladder cancer. ObjectiveTo assess the performance of BE for NMIBC recurrence. Design, setting, and participantsThis was a blinded, single-arm, prospective multicenter study. The inclusion criteria were age ≥22 yr, urothelial carcinoma (UC) being monitored cystoscopically at 3-mo intervals, all UC resected within 12 mo, able to produce 10ml of urine, and able to consent. Outcome measurements and statistical analysisThe BE test characteristics were calculated and compared to cytology and cystoscopy results confirmed by pathology. Results and limitationsOut of 440 patients recruited, 353 were eligible for the performance analysis. Overall sensitivity, specificity, NPV, and positive predictive value were 68.2%, 88.0%, 95.1%, and 44.8%, respectively. Excluding low-grade (LG) Ta recurrences, the sensitivity was 91.7% and NPV was 99.3%. The area under receiver operating characteristic (ROC) curves with and without LG Ta lesions was 0.82 and 0.94, respectively. ConclusionsIn follow-up of NMIBC patients, the BE test showed an overall high NPV of 95.1%, and 99.3% when excluding LG Ta recurrences. With high specificity of 88.0%, the test could be incorporated in NMIBC follow-up since high-grade recurrences would be instantly detected with high confidence. Thus, the current burden of repeat cystoscopies and cytology tests could be reduced. Patient summaryThe Bladder EpiCheck urine test has a clinically relevant and high negative predictive value. Its use in clinical routine could reduce the number of follow-up cystoscopies, and thus associated patient and financial burdens.

Voided urine versus bladder washing cytology for detection of urothelial carcinoma: which is better?

Objective: Cytology is recommended as part of the follow-up of high-grade non-muscle-invasive bladder cancer (NMIBC). However, currently there are no solid guideline recommendations regarding the use of voided urine versus bladder washing for cytology as part of the diagnosis or follow-up of NMIBC. The aim of this study was to investigate whether the cytological outcome was equal regarding the two techniques.Materials and methods: The authors reviewed all outpatient flexible cystoscopies carried out in their department in 2013. Patient records in the registry of pathology were examined and those with simultaneous urine and bladder washing cytology were included. Previous urothelial disease and positive histology within 3 months after the cystoscopy were registered.Results: A total of 1458 patients had both voided urine and bladder washing cytology and were included in the study, of whom 643 (44%) had a history of urothelial disease. An equal outcome of urine and bladder washing cytology was found in 1447 patients (99.2%). For the remaining 11 patients, only four patients underwent further examinations based on cytology findings in addition to what had already been planned after cystoscopy. Of the included patients, 100 (6.9%) had a positive histological outcome within 3 months.Conclusions: In most patients, no relevant difference between voided urine and bladder washing cytology was observed. Therefore, if cytology is indicated, it is recommended to use the test that is most readily available locally. The additional gain in using both urine and bladder wash is minimal, and can therefore be discarded.

Anesthésie locale pour fibroscopie chez l’homme : étude de non-infériorité comparant le Xylocaine® gel à l’Instillagel® Lido

Local anesthesia using urethral gel has been proven to reduce discomfort of male patients during flexible cystoscopy. This study was a non-inferiority study between two lidocain-containing urethral gel (Instillagel® Lido and Xylocaine® gel). A prospective single center study was conducted between June2014and November2014. Male patients seen in the office and in whom a flexible cystoscopy was planned were included in the present study and received urethral instillation of either Xylocaine® gel or Instillagel® Lido at least 5minutes before flexible cystoscopy. No other anesthetic agent was used. Primary endpoint was pain during the procedure, assessed through visual analog scale (VAS) from 0to 10. Four hundred and sixty-one men were included: 233in the Instillagel® Lido group and 228in the Xylocaine® gel group. Indications of flexible cystoscopy non-muscle invasive bladder cancer follow-up in 44% of cases, hematuria work-up in 21% of cases and lower urinary tract symptoms work-up in 35%. Patients' age was comparable betwwen both groups: 64.5years (±1.1) in the Instillagel® Lido group and 66.2years (±1.1) in the Xylocaine® gel group (P=0.29). The mean VAS was 0.8 (±0.1) in the Instillagel® Lido group and 0.6 (±0.1) in the Xylocaine® gel group (P=0.10). The non-inferiority criterion was reached (P<0.001) as the average difference in VAS between the two groups was 0.2with a confidence interval not comprising 1 (CI97.5%: -0.47; 0.07). In this prospective study, Instillagel® Lido was not inferior to Xylocaine® gel for local analgesia during flexible cystoscopy in male patients. 4.

Hexaminolevulinate hydrochloride blue-light flexible cystoscopy in the detection and follow-up of nonmuscle-invasive bladder cancer: cost consequences during outpatient surveillance in Sweden.

This study explored the cost consequences of introducing hexaminolevulinate hydrochloride-guided blue-light flexible cystoscopy (HAL BLFC) as an adjunct to white-light flexible cystoscopy compared with white-light flexible cystoscopy alone, for the detection and management of nonmuscle invasive bladder cancer in Sweden. The model evaluated 231 patients in the outpatient setting after successful initial transurethral resection of the bladder tumor. HAL BLFC introduction across all risk groups resulted in minimal budget impact (+1.6% total cost/5 years, or 189 Swedish Krona [SEK] per patient/year), and translated to cost savings in intermediate- and high-risk groups from year 2. HAL BLFC allowed more outpatient treatment with improved recurrence detection and reduced transurethral resection of the bladder tumors, cystectomies, bed days and operating room time, with minimal cost impact across all risk groups, demonstrating the economic benefits of introducing HAL.

1054 Adequacy and usefulness of EAU guidelines recommendation of routine upper tract imaging in high risk non-muscle invasive bladder cancer follow-up

1054 Adequacy and usefulness of EAU guidelines recommendation of routine upper tract imaging in high risk non-muscle invasive bladder cancer follow-up

Use of Fluorescence In Situ Hybridization to Predict Response to Bacillus Calmette-Guérin Therapy for Bladder Cancer: Results of a Prospective Trial

No reliable methods currently exist to predict patient response to intravesical immunotherapy with bacillus Calmette-Guérin given after transurethral resection for high risk nonmuscle invasive bladder cancer. We initiated a prospective clinical trial to determine whether fluorescence in situ hybridization results during bacillus Calmette-Guérin immunotherapy can predict therapy failure. Candidates for standard of care bacillus Calmette-Guérin were offered participation in a clinical trial. Fluorescence in situ hybridization was performed before bacillus Calmette-Guérin, and at 6 weeks, 3 months and 6 months during bacillus Calmette-Guérin therapy with maintenance. Cox proportional hazards regression was used to assess the relationship between fluorescence in situ hybridization results and tumor recurrence or progression. The Kaplan-Meier product limit method was used to estimate recurrence-free and progression-free survival. A total of 126 patients participated in the study. At a median followup of 24 months 31% of patients had recurrent tumors and 14% experienced disease progression. Patients who had positive fluorescence in situ hybridization results during bacillus Calmette-Guérin therapy were 3 to 5 times more likely than those who had negative fluorescence in situ hybridization results to experience recurrent tumors and 5 to 13 times more likely to have disease progression (p <0.01). The timing of positive fluorescence in situ hybridization results also affected outcomes. For example, patients with a negative fluorescence in situ hybridization result at baseline, 6 weeks and 3 months demonstrated an 8.3% recurrence rate compared to 48.1% for those with a positive result at all 3 points. Fluorescence in situ hybridization results can identify patients at risk for tumor recurrence and progression during bacillus Calmette-Guérin immunotherapy. This information may be used to counsel patients about alternative treatment strategies.

The prognostic value of cytology and fluorescence in situ hybridization in the follow-up of nonmuscle-invasive bladder cancer after intravesical Bacillus Calmette-Guérin therapy

The prognostic value of cytology and fluorescence in situ hybridization in the follow-up of nonmuscle-invasive bladder cancer after intravesical Bacillus Calmette-Guérin therapy

Bladder tumor markers: a review of the literature

Bladder cancer is among the top eight most frequent cancers. Its natural history is related to a combination of factors that impact on its aggressiveness. Cystoscopy and urine cytology are the currently used techniques for the diagnosis and surveillance of non-invasive bladder tumors. The sensitivity of urine cytology for diagnosis is not high, particularly in low-grade tumors. The combination of voided urine cytology and new diagnostic urine tests would be ideal for the diagnosis and follow-up of bladder cancer. However, in order to have some clinical utility, new diagnostic and/or prognostic markers should achieve better predictive capacity that the currently used diagnostic tools. None of the markers evaluated over the last years showed remarkable sensitivity or specificity for the identification of any of the diverse types of bladder cancer in clinical practice. The limitations of the known prognostic markers have led to the research of new molecular markers for early detection of bladder cancer. This research focused in particular on the discovery of biomarkers capable of reducing the need for periodic cystoscopies or, ideally, offering a non-invasive examination instead. In this review, we will examine various new markers of bladder cancer and their value in the diagnosis and follow-up of non-muscleinvasive bladder cancer. When compared with urine cytology, which showed the highest specificity, most of these markers demonstrated an increased sensitivity.

Recent improvements in the detection and treatment of nonmuscle-invasive bladder cancer

In total, 70–80% of newly diagnosed bladder cancers are confined to the mucosa and staged as Ta, T1 or carcinoma in situ according to the 2002 tumor, lymph nodes and metastasis classification. The standard treatment for these nonmuscle-invasive bladder cancers is transurethral tumor resection with or without adjuvant intravesical chemotherapy or intravesical immunotherapy and subsequent follow-up. Diagnosis and follow-up of nonmuscle-invasive bladder cancer offers two main problems. First, approximately 10–20% of all tumors are not seen in standard cystoscopy. Additionally, frequently repeated follow-up cystoscopies are bothersome for the patient. As an adjunct to standard cystoscopy, fluorescence-guided cystoscopy has demonstrated significantly higher tumor detection rates and optimized patient treatment in recent Phase III studies. Second, routinely performed urine cytology is characterized by high specificity but low sensitivity. Today, several urine tests are available that may increase diagnostic accuracy and potentially prolong intervals of follow-up cystocopy. Owing to rather high recurrence rates after transurethral tumor resection in most tumors and high progression rates in poorly differentiated tumors, adjuvant intravesical chemotherapy or intravesical immunotherapy has gained widespread use in patients with nonmuscle-invasive bladder cancer. Only a few further immunomodulatory drugs, such as recombinant cytokines, have shown significant clinical effectiveness. Additional approaches, such as photodynamic therapy with different photosensitizers and thermotherapy in combination with intravesical chemotherapy, have been evaluated in Phase III studies.