Lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) are one of the most common disorders of the aging U.S. male. Over the last decade significant advances have been made in characterizing this abnormality and treating it with medical therapy (such as alpha blockers and 5 alpha reductase inhibitors) and minimally invasive surgical techniques (such as stents, lasers, hyperthermia and others). Despite this, use of non-traditional medical therapies for LUTS has greatly increased in recent years. Most trials evaluating these agents are limited by small size, short study interval and absence of standardized testing instruments. For these reasons there is a need to evaluate non-traditional agents such as saw palmetto and pygeum Africanum in a large scale, randomized, placebo-controlled, long-term trial. In this application, we propose one such study, describe our clinical research environment, including patient population, facilities, personnel, experience with prior studies, and other methods to assure recruitment, protocol compliance, and retention for such a study. We describe our willingness to develop a final protocol and collaborate in performing it.
