Unique methodological issues facing randomized controlled trials of endourologic procedures

Randomized controlled trials provide the optimal design for evaluating the effectiveness of treatment but have not been widely accepted by surgical investigators. Although there are several methodological and ethical difficulties, none is insurmountable. In the United Kingdom, a regulatory agency has been established to supervise the introduction of new medical procedures, and something similar might be seen in the United States, particularly given the pressure from the government and third-party payors for proof of efficacy and cost effectiveness. Endourologists have responded to similar challenges in the past and must continue to do so.