Objectives. To investigate the long-term effects of finasteride on bother and health-related quality of life (HRQOL) in men with symptomatic benign prostatic hyperplasia.

Methods. A large prospective 4-year placebo-controlled trial (PLESS) of 3040 men with moderate to severe lower urinary tract symptoms and an enlarged prostate was performed that included self-administered questionnaires assessing HRQOL.

Results. Significantly greater reductions in bother score were seen for finasteride compared with placebo at every time point after 4 months. Analysis of bother scores by baseline serum prostate-specific antigen (PSA), as it is highly correlated with prostate volume, suggested greater differences from placebo for men with PSA 1.4 ng/mL or greater, primarily due to worsening after the first-year improvement in the placebo group. An activity interference domain score was significantly improved for finasteride over placebo at each time point (P <0.01), with greater treatment differences in men with higher baseline PSA levels. Comparable results were seen for worry at each time point and embarrassment due to urinary symptoms in the last 2 years of the trial. Mean changes in sexual interest and satisfaction were somewhat better for the placebo group overall, as has been previously reported, but little difference between treatments was found in sexual satisfaction measures for men with PSA 1.4 ng/mL or greater.

Conclusions. Compared with placebo, men receiving finasteride had significantly less bother, activity interference, and worry due to urinary symptoms, with more pronounced differences for men with baseline PSA 1.4 ng/mL or greater. As expected, sexual satisfaction and sexual drive were slightly worse for finasteride overall, but little difference in sexual satisfaction measures was found for men with a higher baseline PSA. Thus, HRQOL was improved for finasteride compared with placebo, especially for men with a baseline PSA 1.4 ng/mL or greater.