Complementary and Alternative Medicine for Urological Symptoms(CAMUS)

Exclusion Criteria

• •1. Any prior invasive intervention for BPH.
• •2. Phytotherapy for BPH or a 5-alpha reductase inhibitor within 3 months.
• •3. Alpha blocker within one month.
• •4. Reported allergic reaction to Serenoa repens.
• •5. Taken phenylephrine, pseudoephedrine, tricyclic antidepressants, and anticholinergic or cholinergic medication within 4 weeks of the first screening visit, with the following exception: topical anticholinergic eye drops used for glaucoma.
• •6. Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 6 months.
• •7. Known clinically significant renal impairment (i.e., creatinine greater than 2.0 mg/dl).
• •8. Alanine aminotransferase(ALT)serum glutamic pyruvic transaminase(SGPT), aspartate aminotransferase(AST)serum glutamic oxaloacetic transaminase (SGOT) or gamma-glutamyltranspeptidase (GGT) value greater than 3 times the upper limit of normal in the clinical center lab at SV1.0; confirmed on a second measurement.
• •9. Prothrombin time greater than 3 seconds above the upper limit of normal, or more than 3 seconds above the control value in the clinical center at SV1.0; confirmed on a second measurement.
• •10. Electrocardiogram (ECG) reading at the clinical center at SV1.0 suggesting active ischemia or recent myocardial infarction until appropriate consultation confirms the absence of an acute coronary syndrome.
• •11. Prostate-specific antigen (PSA) level greater than 10 ng/ml at the first screening visit.
• •12. Requires the daily use of a pad or device for incontinence, or International Continence Society male incontinence symptom (ICSmaleIS) score \>14 at screening.
• •13. Unstable medical condition within the past 3 months.
• •14. History or current evidence of carcinoma of the prostate or bladder, pelvic radiation or surgery, urethral stricture, or prior surgery for bladder neck obstruction.
• •15. Active urinary tract disease or has undergone cystoscopy or biopsy of the prostate within one month prior to the first screening visit or has an imminent need for urologic surgery.
• •16. Known primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function.
• •17. Documented bacterial prostatitis within the past year.
• •18. Two documented independent urinary tract infections of any type in the past year.
• •19. Known severe bleeding disorder or need for ongoing therapeutic anticoagulation with coumadin or heparin.
• •20. Cancer, which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years of randomization. A history of bladder cancer or prostate cancer is exclusionary whether the participant is considered cured or not.
• •21. Unable to follow protocol directions due to organic brain or psychiatric disease.
• •22. History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
• •23. Any serious medical condition likely to impede successful completion of the study.