[Efficacy of an alpha-blocker, alfuzosin, on urinary disorders in men with prostatic adenoma. Intermediate results of a European multicenter study]

Author(s): Jardin A

Affiliation(s): Service d'Urologie, Hopital Universitaire de Bicetre, Le Kremlin Bicetre.

Publication date & source: 1988, Ann Urol (Paris)., 22(5):333-40.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

The use of alfuzosin (a competitive post-junctional alpha-blocker) is based on the finding of alpha-adrenoceptors in trigone, urethra and adenoma tissue. Thirty-one European centers participated in this randomized study with parallel groups (alfuzosin versus placebo). The treatment period lasted 6 months with assessments on D14 and every 6 weeks thereafter. The dose was either 7.5 mg or 10 mg/day. Four hundred and seventeen patients were included (alfuzosin = 205, placebo = 212). The demographic data and the characteristics of the benign prostatic hypertrophy were comparable in both groups. There were 30 drop-outs due to inefficacy in the placebo group and 15 in the alfuzosin group. The difference is significant (p = 0.01). Five patients had to leave the study for emergency treatment of acute urinary retention (4 in the placebo group and 1 in the alfuzosin group). Early improvement was observed in the total score (urgency (p = 0.001) and quality of the stream), assessed on the basis of the functional symptoms (diurnal frequency and nocturia, hesitancy, post-void dribbling, urgency, sensation of incomplete emptying of the bladder and quality of the stream). Alfuzosin was demonstrated to be effective with respect to out-flow obstructive symptoms (quality of the stream, hesitancy, sensation of incomplete emptying of the bladder) and other functional symptoms (diurnal frequency and nocturia). The good total score results favor alfuzosin primarily because of its action on urgency and dysuria. The drug was well tolerated clinically. In conclusion, alfuzosin is useful in moderate dysuria in young subjects, during acute episodes in elderly patients and in patients when surgery has to be delayed.