The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.

Inclusion Criteria:

1. Patients with high suspicion/confirmed urothelial carcinoma by CT, CTU, MR and other imaging examinations and meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
2. Patients with highly suspected/confirmed recurrence of urothelial carcinoma who meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
3. The patient agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

• (1) Patients with urothelial carcinoma combined with other malignant tumors; (2) Patients with a history of other non-urothelial carcinoma cancers; (3) Samples that are not urothelial carcinoma in surgical pathology; (4) Samples of Ta/low-grade urothelial carcinoma shown by surgical pathology.

All urothelial carcinoma patients were not Ta stage or low-grade who met the indications for surgery. Surgical modalities include transurethral resection of bladder tumours (TURbt), partial cystectomy, radical nephroureterectomy, and kidney-sparing surgery. Urine samples were collected before and after surgery, and IUrisure methylation test was performed on each urine sample. The follow-up period was 24 months, and the patients underwent routine tests during the follow-up period. The gold standard for recurrence of urothelial carcinoma is surgical/biopsy pathology.