Evaluating the efficacy, safety, and cost of lasers for the treatment of benign prostatic hyperplasia.

This review highlights some of the caveats assessing the available clinical data base for determining the efficacy, safety, and cost of laser systems used to treat benign prostatic hyperplasia. Many new minimally invasive devices have recently been advanced in spite of the limited data base and the lack of properly designed clinical trials. There have been many claims regarding the effectiveness of laser prostatectomy based on the available clinical data. Some important general considerations for interpreting the clinical data base, critically analyzing the study design, and interpreting the data are discussed. Similarly, many claims have been made with respect to the cost of laser prostatectomy; however, insufficient objective data are available for clear determinations of cost. Some of the pertinent issues involved in the cost assessment of laser prostatectomy are also highlighted. It is hoped that this review will provide the reader with some additional insight into the critical assessment of the quality of studies that evaluate the safety, efficacy, and cost of new devices such as the laser.