Effect of finasteride on bother and other health-related quality of life aspects associated with benign prostatic hyperplasia

Objectives. To investigate the long-term effects of finasteride on bother a nd health-related quality of life (HRQOL) in men with symptomatic benign pr ostatic hyperplasia. Methods. A large prospective 4-year placebo-controlled trial (PLESS) of 304 0 men with moderate to severe lower urinary tract symptoms and an enlarged prostate was performed that included self-administered questionnaires asses sing HRQOL. Results. Significantly greater reductions in bother score were seen for fin asteride 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 fr om placebo for men with PSA 1.4 ng/mL or greater, primarily due to worsenin g after the first-year improvement in the placebo group. An activity interf erence domain score was significantly improved for finasteride over placebo at each time point (P <0.01), with greater treatment differences in men wi th higher baseline PSA levels. Comparable results were seen for worry at ea ch time point and embarrassment due to urinary symptoms in the last 2 years of the trial. Mean changes in sexual interest and satisfaction were somewh at better for the placebo group overall, as has been previously reported, b ut little difference between treatments was found in sexual satisfaction me asures for men with PSA 1.4 ng/mL or greater. Conclusions. Compared with placebo, men receiving finasteride had significa ntly less bother, activity interference, and worry due to urinary symptoms, with more pronounced differences for men with baseline PSA 1.4 ng/mL or gr eater. As expected, sexual satisfaction and sexual drive were slightly wors e for finasteride overall, but little difference in sexual satisfaction mea sures was found for men with a higher baseline PSA. Thus, HRQOL was improve d for finasteride compared with placebo, especially for men with a baseline PSA 1.4 ng/mL or greater. UROLOGY 54: 670-678, 1999. (C) 1999, Elsevier Sc ience Inc.