The purpose of this request is to establish a cooperative group of approximately 10 prostate evaluation and treatment centers nationwide which will develop and conduct a prospective, randomized, double-blind, placebo controlled clinical trial to determine whether Saw Palmetto(SP) and/or Pygeum Africanum(AP) can prevent the clinical progression of benign prostatic hyperplasia (BPH). BPH is a common disease in men over 50 which can lead to bothersome voiding symptoms, urinary retention, permanent bladder damage, renal failure, urinary tract infections, urosepsis or urinary incontinence. Treatment options with documented efficacy include medication, several thermotherapy options, and surgical prostatectomy. Phytotherapy is another treatment option for BPH which is used widely in Europe and is experiencing increasing utilization in the United States. Two common phytotherapeutic agents SP and PA. Despite the widespread use of these substances, there is no convincing data in the literature which demonstrates efficacy for the treatment of BPH. These phytotherapeutic substances do appear to be safe from the patients' perspective. The objective of this trial is to determine if SP and/or PA can prevent the clinical progression of BPH, as defined by the development of: acute urinary retention, renal insufficiency due to BPH, recurrent urinary tract infections, urinary incontinence, or an increase in the international prostate symptom score (IPSS) of 4 or more points over a four year trial. Parameters to be assessed in the subjects enrolled in this trial include IPSS, peak urinary flow rate, post void residual volumes, quality of life and sexual health questionnaires, prostate size determined by prostatic ultrasound, blood count and blood chemistries, urinalysis, serum hormone levels, a history and physical examination. Patients will be assessed every 3 months over a four year trial period. The chosen group of collaborators will meet to design the protocol including diagnostic criteria, inclusion/exclusion criteria, safety measurements and quality of life outcome measurements. The trial will commence after the protocol has been developed, an operations manual has been completed and data collection techniques have been established. Each site will obtain IRB approval of the final protocol. When the study is complete and the data has been analyzed, publication of relevent results will be done.
