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.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
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Washington University
Schools of Medicine
Saint Louis
United States
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Lee, Jeannette Y; Moore, Page; Kusek, John et al. (2014) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. J Altern Complement Med 20:48-52
Barry, Michael J; Cantor, Alan; Roehrborn, Claus G et al. (2013) Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J Urol 189:987-92
Andriole, Gerald L; McCullum-Hill, Christie; Sandhu, Gurdarshan S et al. (2013) The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. J Urol 189:486-92
Barry, Michael J; Meleth, Sreelatha; Lee, Jeannette Y et al. (2011) Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 306:1344-51
Andriole, Gerald L; Kibel, Adam S (2011) Editorial for ""Prediction of significant prostate cancer diagnosed 20 to 30 years later with a single measure of prostate-specific antigen at or before age 50"". Cancer 117:1110-2
Lee, Jeannette Y; Foster Jr, Harris E; McVary, Kevin T et al. (2011) Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med 17:469-72
Lee, Jeannette; Andriole, Gerald; Avins, Andrew et al. (2009) Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials 6:628-36