Interstitial Laser Coagulation and High-Intensity Focused Ultrasound for the Treatment of Benign Prostatic Hyperplasia

Abstract

Medical therapies for benign prostatic hyperplasia (BPH) have been critically investigated by well-designed clinical trials, which is the current model for assessing the safety and efficacy of any treatment for BPH. Pivotal medical studies for BPH are prospective, multicenter, randomized, double-blind, and placebo-controlled (1,2). This study design is the accepted standard to assess clinical safety and efficacy. For ethical and practical reasons, it is often more difficult to design surgical studies that meet all of these criteria. Many of the sponsoring companies do not have adequate financial resources to perform multicenter clinical trials. Designing a trial to minimize bias is essential, particularly because of the public’s somewhat automatic acceptance of new technology, in particular laser therapy, as state-of-the-art treatment. Many patients enroll in clinical trials specifically because of the favorable perception that new technology conveys, and this bias is likely to influence subjective outcome parameters. Few studies control for these important biases. There is not a single device trial that is equivalent in design when compared with the pivotal medical trials.