Repeated 5-aminolevulinic Acid Instillations During Follow-up in Non-muscle-invasive Bladder Cancer: A Randomized Study

Abstract

Background/aim: Non-muscle invasive bladder carcinoma (NMIBC) is highly recurrent. We studied if 5-aminolevulinic acid (5-ALA) instillations before transurethral resection of bladder tumours (TURBT) and cystoscopy extend the time to recurrence during follow-up with NMIBC patients.

Patients and methods: A prospective multicenter study enrolled 328 NMIBC patients. All TURBTs and control cystoscopies during the one-year study period were done with or without 5-ALA instillations. The primary endpoint was time to recurrence. The secondary endpoints were time to recurrence after 7.5, 10.5, and 13.5 months and the number of patients with progressive disease.

Results: The overall median follow-up time was 80.4 and 87.0 months for the control and study groups, respectively. There was no statistical difference in time to first recurrence between the two groups.

Conclusion: We could not obtain significant differences between the control and 5-ALA groups in tumour recurrence among patients with NMIBC.

Keywords: 5-aminolevulinic acid; Non-muscle-invasive bladder cancer; fluorescence cystoscopy; photodynamic diagnosis; tumour detection.