Treatment satisfaction of patients with lower urinary tract symptoms: randomised controlled trials vs. real life practice.

Abstract

Randomised controlled trials (RCTs) are an important scientific tool to determine the efficacy and tolerability of a given treatment relative to placebo or other treatment forms. However, due to strict inclusion and exclusion criteria the patient populations in RCTs may not be fully representative for those routinely consulting the physician. Moreover, participation in a formal study puts physician and patient in a situation where they may react different than in real life. In contrast real life practice (RLP) studies cannot determine treatment efficacy or tolerability in absolute terms since they typically do not include a control group and are purely observational. On the other hand, they tend to be more representative for real treatment outcomes. Thus, RCTs have high internal but less external validity whereas RLP studies have less internal and greater external validity. Hence, RCTs and RLP studies should not be considered as mutually exclusive but rather as complementing each other. Specific advantages and disadvantages of RCTs and RLP studies will be discussed using published evidence for the treatment of lower urinary tract symptoms suggestive of benign prostatic obstruction with alpha1-adrenoceptor antagonists and other treatments.