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 ¼ 187) or a placebo (n ¼ 183) intravesically before cystoscopy. Each group underwent cystoscopy under visible white light and under fluorescent light followed by transurethral tumor resection. The primary study objective was to evaluate the 12-month recurrence-free survival. RESULTS: Slightly more patients with tumors were detected by using 5-ALA than by using the placebo (88.5% vs 84.7%). The mean numbers of tumor specimens per patient were 1.8 (5-ALA) and 1.6 (placebo). Intrapatient comparison of fluorescent light versus white light cystoscopy in patients randomized to receive 5-ALA showed a higher tumor detection rate with fluorescent light than with white light cystoscopy. In patients receiving 5-ALA cystoscopy, the percentage of lesions that would not have been detected in these patients by white light cystoscopy ranged between 10.9% (pT1) and 55.9% (atypia). Progression-free survival was 89.4% (5-ALA) and 89.0% (placebo) (P ¼ .9101), and recurrence-free survival 12 months after tumor resection was 64.0% (5-ALA) and 72.8% (placebo) (P ¼ .2216). CONCLUSIONS: In comparison to the placebo, 5-ALA cystoscopy did not increase the rates of recurrence-free or progression-free survival 12 months after tumor resection. Although more tumors per patient were detected in the 5-ALA group, the higher detection rate did not translate into differences in long-term outcome.

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. The primary study objective was to evaluate the 12-month recurrence-free survival. Results: Slightly more patients with tumors were detected by using 5-ALA than by using the placebo (88.5% vs 84.7%). The mean numbers of tumor specimens per patient were 1.8 (5-ALA) and 1.6 (placebo). Intrapatient comparison of fluorescent light versus white light cystoscopy in patients randomized to receive 5-ALA showed a higher tumor detection rate with fluorescent light than with white light cystoscopy. In patients receiving 5-ALA cystoscopy, the percentage of lesions that would not have been detected in these patients by white light cystoscopy ranged between 10.9% (pT1) and 55.9% (atypia). Progression-free survival was 89.4% (5-ALA) and 89.0% (placebo) (P = .9101), and recurrence-free survival 12 months after tumor resection was 64.0% (5-ALA) and 72.8% (placebo) (P = .2216). Conclusions: In comparison to the placebo, 5-ALA cystoscopy did not increase the rates of recurrence-free or progression-free survival 12 months after tumor resection. Although more tumors per patient were detected in the 5-ALA group, the higher detection rate did not translate into differences in long-term outcome.

THE JOURNAL OF UROLOGy® analysis of NMP22 protein marker prior to cystoscopy. Testing was blinded.RESULTS: Of the 1328 patients; 545 had no urinary tract disease, 704 had benign disease and 79 had cancer. Patients with no disease included 39% males, 30% smokers and 93% with hematuria (11% gross and 89% micro). Patients with benign disease included 69% males, 40% smokers and 90% with hematuria (19% gross and 81% micro). Patients with cancer included 80% males, 48% smokers and 98% with hematuria (51% gross and 49% micro). Overall positive predictive value (PPV) of the BladderChek test was 20% and negative predictive value (NPV) was 97%. Higher incidence rate improves PPV, thus PPV was higher in men (24%) than women (13%). Among men, PPV increased with smoking (35%), gross hematuria (51%) and both factors (71%). Among women the impact on PPV of smoking (10%) and gross hematuria (29%) was less. The highest PPV was 78% in men aged 65 or older with smoking history and gross hematuria. Low incidence rate improves NPV, so for all women under age 65 the NPV was 100%, even among those who smoked or had gross hematuria.CONCLUSIONS: The positive predictive value of the NMP22 BladderChek Test improves in patients at higher risk for bladder cancer, and can be as high as 78% in older men with gross hematuria who smoke. Negative predictive value is enhanced in lower risk patients, up to 100% in women under age 65.