Subjects were first enrolled into the CAMUS trial in 2008. The project's end date will occur prior to the completion of all study-related activities. The purpose of this application is to gain approval and funding to complete all study-related procedures and activities for those subjects whose enrollment will exceed the current project end date. Completing and closing out the study will directly aid in preparation of the final dataset and planning publications based on the study results. Subjects in this trial suffer from benign prostatic hyperplasia and lower urinary tract symptoms, more commonly known as BPH/LUTS. The phytotherapy serenoa repens is being studied in this trial and its effectiveness will be compared to placebo. The project is jointly supported by the NIDDK/NCCAM as it meets the mission of both of these agencies. The NIDDK conducts and supports research on many chronic and costly diseases affecting the public health. In 2008, BPH/LUTS resulted in approximately 4.4 million visits to a doctor's office and accounted for over $1 billion in health care costs. Additionally, this trial is a direct response to the 2008 NIDDK Prostate Research Strategic Plan which aims to support research which might help determine clinical benefit to phytotherapeutics. The mission of NCCAM is to explore complementary and alternative healing practices in the context of rigorous science. The rigor of a double-blind, randomized, placebo-controlled trial on a widely available phytotherapy is certainly congruent with the mission of NCCAM. As aforementioned, the study design lends itself to being a rigorous, scientific trial. Both placebo and study drug were supplied by Madaus/Rottapharm. Randomization was accomplished via an internet-based system developed by the Data Coordinating Center (DCC). Going fonward, the completion ofthe trial and finalization ofthe database will hopefully yield generalizable knowledge regarding the use of serenoa repens for BPH/LUTS.
BPH/LUTS is a paramount public health concern. The prevalence of BPH/LUTS increases with a man's age, and contributes significantly to morbidity. Overall outcome measures of men with BPH/LUTS resemble those of other chronic health condition and treatment of this condition is of considerable expense to the U.S. health care sytem.
