Prospective follow-up of 3,228 patients suffering from clinical benign prostatic hyperplasia (BPH) treated by alfuzosin in general practice for 3 years.

Objective: To determine (a) the amplitude and duration of reduction of the symptom score and improvement of the HRQL score (including sexual function) , (b) the adverse effects and (c) the incidence of acute urinary retention and prostatic surgery during the 3 years of alfuzosin treatment. Material and Methods: 3,228 patients suffering from BPH were included by 81 2 centers in a 3-year open prospective study and were treated with alfuzosi n (immediate release) at the recommended dosage. A symptom score (modified Boyarsky) and a specific HRQL score, comprising 20 items including 3 questi ons on sexuality (Urolife(TM) BPH Qol20) were self-administered on inclusio n and after 3, 6, 12, 18, 24, 30 and 36 months. Results: 2,579 patients (79.9%) completed the 3 years of the study. The sym ptom score was significantly decreased by 54% at 3 months and this reductio n was maintained after 36 months (-48.4%): the HRQL score was significantly improved by 45.4% at 12 months (+43.4%). Alfuzosin was well tolerated: the qualitative and quantitative distribution of adverse effects was identical to that previously observed in placebo-controlled trials (vertigo-dizzines s: 2.1%). Adverse effects were responsible for 4.2% of drop-outs from the t rial. 120 patients (3.7%) were operated for BPH and 9 patients (0.3%) devel oped acute urinary retention. Conclusion: This prospective study confirms the long-term safety use of alf uzosin under routine general practice conditions and emphasizes the need to measure HRQL in the context of the patients's opinion.