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Objective: Intravesical bacillus Calmette-Guéin (BCG) is an established treatment in superficial bladder cancer, however its local and systemic toxicity continues to be a cause for concern. This trial was conducted using three different doses of BCG to determine whether lowering the dose of BCG could reduce toxicity without compromising its efficacy. Materials and Methods: From July 2002 to June 2006, 152 patients with superficial bladder cancer entered the trial. The patients were randomized to receive three different doses of BCG: 40, 80 and 120 mg respectively. There were no significant differences in clinical and pathological characteristics among the three groups. 24 patients could not be followed till the end of the study due to poor compliance. At completion of the study, 40 patients could be evaluated in group A (40 mg), 48 in group B (80 mg) and 40 in group C (120 mg). Results: Following treatment, patients were evaluated for a mean follow-up of 36 (range 18 to 52) months. No significant difference in recurrence rate (20 vs. 25 vs. 20% respectively; P >0.05) was observed among the groups and no progression of the disease was seen. Significant differences were observed among groups A, B and C in local toxicity (30 vs. 41.7 vs. 70% respectively; P <0.01). Systemic toxicity was more common in group C as compared to groups B and A ( P <0.01). Conclusion: Reduction in the dose of intravesical BCG can reduce the toxicity associated with the treatment without affecting the effificacy of therapy. [ABSTRACT FROM AUTHOR]