Abstract: Objective：To systematically review the significance of urine cytokeratin 20 (CK20) mRNA determined by RT-PCR and urinary cytological examination (UCE) in the diagnosis of bladder cancer. Methods：The literatures on the studies which compared the value of urine CK20 mRNA determined by RT-PCR with UCE in the diagnosis of bladder cancer were systematically retrieved from PubMed, Web of Science, The Cochrane Library (before Issue 1, 2014), Embase, CNKI, VIP and CBM databases. The QUADAS items were used to evaluate the quality of the literatures. The software Meta-Disc 1.4 was used to analyze the data. Results：Eleven case control studies involving in 1 631 subjects were included. The results of meta-analysis showed that the pooled sensitivity, specificity, positive likelihood ratio (LR), negative LR of urine CK20 mRNA and UCE for the diagnosis of bladder cancer were 0.80 (0.78, 0.83) vs 0.53 (0.49, 0.56), 0.93 (0.91, 0.95) vs 0.90 (0.88, 0.93), 12.46 (5.22, 29.75) vs 6.04 (3.37, 10.84) and 0.22 (0.18, 0.28) vs 0.51 (0.42, 0.63), respectively. The sensitivity of urine CK20 mRNA and UCE for the diagnosis of bladder cancer increased with the increasing of bladder cancer grade and stage. The areas under summary receiver operating characteristic (SROC) curve were 0.872 6 and 0.795 4, respectively, and Q* indices were 0.803 0 and 0.731 9, respectively. Conclusion：The sensitivity of urine CK20 mRNA determined by RT-PCR for the diagnosis of bladder cancer is superior to that of UCE, and it is more suited to the early diagnosis of bladder cancer.