The role of randomized controlled trials in evidence-based urology

To review the current and future role of randomized controlled trials (RCTs) in urology. A review of the urological literature was performed to assess the current role of RCTs in urology. These findings were put in context of current practice, and methodologic limitations of observational study design were discussed. Several RCTs have improved treatment of urology patients. However, overall, few studies in the urologic literature convey high-level evidence. RCTs represent the only study design that can assess causality, thus are the only means to significantly advance knowledge about therapy and improve patient care. Increased incidence and improved quality of RCTs may be achieved through education, community outreach, and better access to research infrastructure. RCTs have significantly improved urologic practice. RCTs are superior to observational studies because of decreased risk of bias and confounding. To further advance clinical practice, clinical trials must play a predominant role and should be embraced by the urology community.