The biodistribution and resulting pattern of transgene expression were determined following intravesical administration of an adenoviral vector carrying the luciferase reporter gene (AdLuc). Female BALB/c mice were subjected to intravesical instillation of 1 x 10(9) or 5 x 10(9) plaque-forming units of AdLuc. After sacrifice, transgene expression was detected in tissues using luciferase assays; vector DNA was detected by vector-specific polymerase chain reaction. These experiments showed very little vector dissemination outside of the bladder by this route of administration. High-level expression of the vector transgene in the bladder was found to diminish by severalfold after 3 days. In a supporting study, vector dissemination and resulting transgene expression were determined following tail vein injection of 5 x 10(9) plaque-forming units of AdLuc. Vector was distributed to and expressed in every organ analyzed, with the highest concentration and level of expression observed in the liver.