To what extent do real life practice studies differ from randomized controlled trials in lower urinary tract...

To compare the real-life practice studies and randomized controlled trials on benign prostatic hyperplasia in order to understand the applications of the data from the two types of study.

Until recently, much of the available information on benign prostatic hyperplasia has come from randomized controlled trials conducted by secondary care urologists on selected populations of patients, who are likely to represent the more symptomatic among the cohort of men with lower urinary tract symptoms in the community. The strict inclusion criteria in these trials led to uncertainty about the applicability of the results to community populations. Moreover, as patients in randomized controlled trials are specially recruited, rather than being drawn from a general population of men with lower urinary tract symptoms, the calculations of incidence and prevalence rates may not be possible. In the last few years, there have been a few important real-life practice studies such as the Triumph project, the Quadraet study and the ALF-ONE study, which have provided very useful data regarding the incidence and prevalence of lower urinary tract symptoms/benign prostatic hyperplasia, the incidence of acute urinary retention, the impact of therapy on the risk of surgery related to benign prostatic hyperplasia and the predictors of disease progression during treatment with alpha-blocker.

As the results from randomized controlled trials cannot always be generalized to daily urological practice, it is important to complement them with data made available by the real-life practice studies. In order to do that, the salient features in the methodology of both types of study must be understood.