Guidance for clinical investigations of devices used for the treatment of benign prostatic hyperplasia

For nearly a century surgery was the only therapeutic option in the treatment of obstructive uropathy induced by benign prostatic hyperplasia (BPH). The last few years have witnessed an array of new emerging strategies of management-pharmacological, hormonal, thermal and device. Much of the present existing data concerning the outcomes of these new therapies remain unpublished and are of relatively short followup intervals, and few of these studies use common or comparable protocols. This plethora of study methodology makes comparison of these therapies, with each other and with existing therapies, difficult. However, some of these therapies are being advocated and are in current use nationwide, while others await introduction. Our nation's health care delivery system is entering a new era. It will no longer be adequate merely for a new emerging therapy to be safe and to have a benefit. Food and Drug Administration clearance will no longer be the only requirement for access to the marketplace. In this new era it will be increasingly important to document that new therapies are not only effective but how effective compared with existing established therapies and compared with other new competing therapies. Furthermore, the cost-effectiveness of each therapy will be a vital factor, particularly in issues of duration of response and need for subsequent treatment. These later factors will in the long term have enormous impact on the total definitive cost of any treatment. This will be especially true in the management of nonlethal diseases, such as BPH, in which the majority of therapy is directed at improvement in quality of life and not at preservation of life. In view of the foregoing facts, and in an effort to bring about some standardization to the assessment of BPH therapies, the American Urological Association (AUA) New Technology Assessment Committee, chaired by Dr. Jeffrey Dann and working in cooperation with Dr. Jerry Blaivas, developed the following parameters for the evaluation of therapies for BPH. The Board of Directors of the AUA endorsed these parameters. Investigators studying new BPH treatments can adopt, modify or reject them as they see fit. Their publication in The Journal of Urology provides these parameters a quotable source in the peer-reviewed literature creating a resource that will hopefully assist in bringing to the literature clinical trials that allow proper assessment and effective comparison of the treatment strategies.