Clinical effects of terodiline hydrochloride on urinary frequency and sense of residual urine--a double blind clinical trial using flavoxate hydrochloride as a control

A double blind clinical trial was performed as a multicenter study to determine the usefulness of terodiline hydrochloride (HCl), an anticholinergic and calcium antagonistic agent, for urinary frequency or sense of residual urine in patients with psychogenic diseases, chronic prostatitis or chronic cystitis. Either 24 mg of terodiline HCl a day or 600 mg of flavoxate HCl a day was given for 4 weeks. One hundred and ninety-nine patients completed the test. The final global improvement rating was 70% in patients given terodiline HCl and 48% in patients given flavoxate HCl. The difference was statistically significant (p less than 0.01). Diurnal and nocturnal urinary frequency and urinary incontinence were less in patients given terodiline HCl than in patients given flavoxate HCl (p less than 0.01). No difference was noted between the two agents in relieving sense of residual urine. Compared with the control period, the average urinary frequency decreased 2.0 times a day in patients given terodiline HCl and 0.7 times in patients given flavoxate HCl. The difference was statistically significant (p less than 0.01). Adverse effects were observed in 12% of the patients given terodiline HCl and in 16% of the patients given flavoxate HCl. They included thirst, difficult urination, constipation, slight increase of serum GOT, GPT or alkaline phosphatase, and so forth. They disappeared with discontinued use of the agent. The global utility rating was 68% in patients given terodiline HCl and 45% in patients given flavoxate HCl, the difference being significant (p less than 0.01). These results indicate that terodiline HCl is useful for the treatment of urinary symptoms in patients with psychogenic diseases, chronic prostatitis or chronic cystitis.