The proposal is a response for a research project (cooperative agreement) by the NIH-NIDDK for consideration for one of 10 Clinical Evaluation and Treatment Centers (CETC) forming a consortium to develop and conduct a randomized placebo controlled trial to evaluate whether the use of Saw palmetto (SP) or Pygeum africanum (PA) can prevent the progression of BPH. Health Relatedness: BPH is the most common neoplastic condition afflicting men and constitutes a major factor impacting Americans. Current studies estimate 30% of American males will require a surgical procedure to correct this problem sometime in their life. Increasing attention has been paid to plant extracts (or phytotherapy) use by patients to self-treat medical ailments such as BPH. Until more appropriately conducted trials are undertaken, the efficacy of phytotherapeutic agents will remain unproven. This study will be crucial to answering that question as well as others pertaining to the progression of BPH.
Specific Aims : The primary aim of this study is to address whether SP or PA alter BPH progression or simply delay the time to surgical therapy. The data accumulated should provide evidence regarding long term effects of these therapies on objective parameters of BPH including the AUA symptom score, maximal urinary flow rates, or prostate size and how these medications compare in their impact on the same. Design and Method: In three treatment arms 1000 patients with symptoms of BPH will be assigned to either SP, PA or placebo and followed for 4-6 years. Progression parameters will include: 1) changes in the AUA symptom score, 2) urinary retention, 3) recurrent UTI, 4) renal insufficiency, 5) urinary incontinence or 6) crossover to known therapy. Objective parameters of BPH will include prostate size, maximal urinary flow rates, and AUA symptom score. Secondary Aim: Unique to this submission is whether a chief complaint analysis, sleep scale measures or direct/indirect healthcare costs analysis provides reliable or useful information.
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