A total of 112 patients with recurrent lower urinary tract infection (UTI) completed the 6-month period of the trial. Patients were treated for 3 months, under double-blind conditions, with one capsule daily of either Uro-Vaxom (UV) or placebo, together with an antibiotic or chemotherapeutic agent when necessary, and observed for a further 3 months. During the 6 months of the trial a significant decrease in the number of recurrences (p < 0.0005) was noted in the UV group as compared to the placebo group. A total of 67.2% of the patients had no recurrences (p < 0.0005). The incidence of bacteriuria (germs > or = 10(5)/ml), dysuria and leukocyturia was significantly reduced. UV was well tolerated, no side effects were recorded during the trial. The drug is a useful adjuvant for the management of UTIs and for the prevention of recurrences.