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Painless hematuria has remained a diagnostic challenge in daily urological practice. Key problem in the assessment of these patients is the discrimination between malignant and non-malignant conditions. In this prospective study the role of immunocytology in the evaluation of patients with hematuria was investigated. Ucyt is a commercially available immunocytological assay based upon microscopical detection of tumor-associated antigens on the membrane of urothelial cells by immunofluorescence. Between October 2000 and July 2007, 301 consecutive patients with a first episode of painless hematuria without prior transitional cell carcinoma were included. Urine samples were obtained from all patients and examined cytologically and immunocytologically. Clinical assessment by physical examination, laboratory tests, endoscopy and imaging in 228 cases with microhematuria and 66 cases with gross hematuria yielded bladder cancer in 10 (4.6%) and 17 (27%) patients, respectively. Clinical workup demonstrated that composition of both groups was entirely different. Sensitivity of cystoscopy and immunocytology was similar in both groups. Furthermore, a negative finding in cystoscopy and immunocytology virtually excluded the presence of urothelial cancer. However, while predictive values of immunocytology were clearly superior to cytology in gross hematuria, cytology performed better in the microhematuria cohort. Combination of cystoscopy and immunocytology yield 100% sensitivity in the assessment of patients with painless hematuria. Based upon performance characteristics the authors recommend to replace urine cytology by a more sensitive marker like immunocytology in gross hematuria. In patients with microhematuria immunocytology could be used to select for patients at risk for urothelial cancer and thus spare negative patients from further examinations.

No abstract

, 61 consecutive patients with a first episode of painless gross haematuria, but no previous transitional cell carcinoma, were included. Urine samples were obtained from all patients and examined cytologically and immunocytologically. RESULTSClinically (by physical examination, laboratory tests, endoscopy and imaging) there was bladder cancer in 17 patients (28%); further diagnoses were benign prostatic enlargement (20, 33%), urinary tract infection (seven, 12%), urolithiasis (two, 3%), and 'further conditions' (seven, 12%). In 10 patients (16%) the reasons for haematuria were not disclosed. Of the 61 samples, 59 (97%) were assessable by cytology and immunocytology. For cystoscopy, immunocytology and conventional urine cytology the sensitivity was 76%, 88% and 47%, and the specificity 100%, 77% and 95%, respectively. Two bladder tumours were not detected by cystoscopy and immunocytology (one each), and two upper urinary tract tumours were diagnosed by imaging and immunocytology. CONCLUSIONSThe combination of cystoscopy and immunocytology gave 100% sensitivity, while combining cystoscopy and cytology only marginally improved the sensitivity of cystoscopy alone. As sensitivity appears to be of key relevance in assessing patients with gross haematuria, we suggest adding immunocytology to the diagnostic protocol in this situation. KEYWORDS gross haematuria, bladder cancer, immunocytologyStudy Type -Diagnostic (exploratory cohort study) Level of Evidence 1b

The high sensitivity and good specificity of immunocytology is comparable with that reported in the literature despite a very low disease prevalence in this population. If assessment of these patients would have only been based on immunocytology, 180 costly and invasive diagnostic procedures would have been saved, with only 29 individuals (14%) undergoing these examinations unnecessarily. The authors conclude that these findings justify further investigation of this issue.