Detection and clinical outcome of urinary bladder cancer with 5-aminolevulinic acid-induced fluorescence cystoscopy : A multicenter randomized, double-blind, placebo-controlled trial.

Background: The medical community lacks results from prospective controlled multicenter studies of the diagnostic efficacy of 5-aminolevulinic acid (5-ALA) cystoscopy on tumor recurrence in patients with superficial bladder tumors.

Methods: A prospective randomized, double-blind, placebo-controlled study was conducted in 370 patients with nonmuscle-invasive urinary bladder carcinoma who received either 5-ALA (n = 187) or a placebo (n = 183) intravesically before cystoscopy. Each group underwent cystoscopy under visible white light and under fluorescent light followed by transurethral tumor resection.