Prospective study of men with clinical benign prostatic hyperplasia treated with alfuzosin by general practitioners: 1-year results.

OBJECTIVES

To investigate in men with benign prostatic hyperplasia (BPH) treated in the general practitioner setting (1) the magnitude and durability of symptom score improvement with alfuzosin; (2) the effect on patients perceived health-related quality of life (HRQL) and sexuality, (3) adverse outcomes and treatment failure; and (4) progression to acute urinary retention and prostate surgery.

METHODS

A large, open outcome study was undertaken in the general practitioner setting in France, and a cohort of men with symptomatic BPH who received alfuzosin for 12 months was established. A total of 5849 patients (mean age 66.7 years) were enrolled by 1508 general practitioners in France. Men were examined at baseline and at 3 months, 6 months, and 1 year. To produce standardized outcome measures of disease-specific health status, under the conditions of routine care in the community, patients in the study completed a self-administered symptom questionnaire (score range 0 to 40) and a new, validated BPH-specific HRQL questionnaire (score range 0 to 200). Questionnaires were completed at baseline and during follow-up at 3, 6, and 12 months.

RESULTS

Alfuzosin was effective in reducing symptoms; 98% (420) of severely and 85% (2479) of moderately symptomatic patients experienced improvement. At 3 months, the global symptom score was reduced by 9.49 +/- 0.08 (-53%), and this reduction persisted for the remainder of the study (-9.76 +/- 0.11). In contrast to the global reduction of symptom scores, there was a time-dependent improvement (+18.41 +/- 0.32 [+30%], +18.45 +/- 0.54 [+37%], and +23.42 +/- 0.57 [+43%] at 3, 6, and 12 months, respectively), in patients' perception of HRQL status. The magnitude of the improvement in HROL status was significantly more pronounced for those patients who had moderate or severe nocturia and daytime frequency at baseline than for those who had mild levels of the same symptoms. Sexuality score at baseline was significantly related to age and was significantly (P < 0.0001) higher in patients less than 70 years old than in older patients. Improvement in patients' perceived sexuality was significant at 12 months (P < 0.0001) and was correlated with age.

CONCLUSIONS

The results of this large cohort study demonstrate the effectiveness of alfuzosin in reducing symptom severity and improving HRQL status over a 12-month period in men with BPH. It also suggests that HQRL and symptom severity are different and complementary entities. The results of the present study highlight the improvement in HRQL and patients' perceived sexuality that can be achieved in symptomatic patients with BPH receiving a 12-month course of alfuzosin therapy.