The main aim of this multicenter observational study was to assess the impact on quality of life (QoL) of 3 months' treatment with an alpha 1-blocker, alfuzosin, 2.5 mg t.i.d., in patients suffering from symptomatic benign prostatic hyperplasia (BPH). Safety and efficacy evaluations were secondary objectives. Nine hundred and ninety patients were enrolled; 940 were evaluable for per-protocol analysis. On day 84, all the three indices of the QoL self-questionnaire were significantly improved in comparison with baseline: mental health +0.4 (2.0%; p < 0.01); general health +0.6 (5.4%; p < 0.01, and, especially, activity +1.4 (13.4%; p < 0.01). Improvement was more marked in patients with severe symptoms at baseline (activity index: +25.6%). Alfuzosin also significantly relieved BPH symptoms according to the Maine Medical Assessment Program (total mean score: day 28 -3.07; day 84 -4.44) and Madsen-Iversen indexes (total mean score: day 28 -5.29; day 84 -7.98). Improvement was more marked in patients with severe symptoms at baseline. Subjective improvement was confirmed by objective measurements (uroflowmetry and residual volume). Fifty-two patients (5.2%) experienced one or more drug-related adverse medical events, mainly within the first 4 weeks of treatment (n = 46; 4.6%). Twenty-seven (2.7%) patients dropped out prematurely from the study for safety reasons. Forty vasodilatory events and 45 nonvasodilatory events were reported. Slight, not clinically significant decreases of blood pressure were observed but heart rate was not modified. In this study, 3 months' treatment with alfuzosin had a positive impact on patients' QoL by relieving their symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)