At the authors' institution, as part of the on-going Dornier National Biliary Lithotripsy Study, 174 patients with gallstones were randomly assigned to receive either ursodeoxycholic acid (UDCA) or placebo for 6 months after undergoing extracorporeal shock wave lithotripsy (ESWL). Six weeks after ESWL, 40 (23%) patients were re-treated for gallstone fragments larger than 5 mm in diameter. No significant difference in the UDCA- and placebo-treated patients was noted. The overall 6- and 12-month stone-free rates for all patients with initially noncalcified stones were as follows: UDCA patients, 31% and 36%, respectively, and placebo patients, 21% and 23%, respectively (P less than .05). In patients with a single, noncalcified gallstone that was at most 20 mm in diameter, the 12-month stone-free rates were as follows: UDCA patients, 60%, and placebo patients, 33% (P less than .01). Patients with noncalcified stones that were 11-20 mm in diameter who were treated with UDCA had a higher rate of stone clearance than placebo patients. At 6 months, the authors' previous study demonstrated no significant difference in the two groups of patients. However, the stone-free rate at 12 months was noted to be significantly higher for patients with a single, noncalcified stone that was at most 20 mm in diameter begun on UDCA than for all other groups of patients.