Effect of intravenous alfuzosin on urethral pressure in patients with neurogenic bladder dysfunction. DORALI Study...

In order to assess the ability of a single intravenous (i.v.) injection of alfuzosin, a selective alpha-1 blocker, in reducing high urethral tone in patients with symptomatic neurogenic bladder dysfunction (NBD), 163 patients (mean maximal urethral pressure [MUP] 108 +/- 46 cm H2O) were enrolled in a double-blind, placebo-controlled, parallel-group trial and were randomly allocated to receive 0.5 mg (n = 45), 1 mg (n = 41), 2 mg (n = 39) alfuzosin or placebo (n = 38). The decrease in MUP was dose-dependent and statistically significant (P < or = 0.05) for 1 and 2 mg alfuzosin (respectively, 43 +/- 28 cm H2O and 46 +/- 27 cm H2O decreases vs. baseline) in comparison with placebo (23 +/- 30 cm H2O). The 2 mg dose level was the most effective leading to a > or = 30 or 50% decrease in MUP in, respectively, 69 and 44% of patients. The safety of all three alfuzosin dose levels was satisfactory and comparable to placebo. I.v. alfuzosin induces, in a dose-related manner, a clinically significant decrease in urethral pressure in patients with NBD and high urethral tone, and may be safely used as a pharmacological test as part of an urodynamic investigation.