Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
The CAMUS trial will test Saw palmetto in about 369 men. Men who decide to be part of the
 CAMUS trial will be given one out of two possible treatments at random. One out of every two
 men would get an inactive placebo treatment. One out of every two men would get Saw palmetto
 pills.

 This kind of scientific study is the best way to find out if the plant extracts really work
 to prevent men with benign prostatic hyperplasia (BPH) from getting worse. During the study,
 men will not know which of the two treatments they are assigned to. They will be followed
 very closely by a study team every 12 weeks to see how they are doing. Men in the CAMUS trial
 will be studied over 72 weeks. Tests and all medications needed as part of the study will be
 provided at no charge to the participant. Participants will be responsible for all other
 costs not associated with the study tests and medications. All information on study
 participants will be held in the strictest confidence and no one would have access to patient
 information other than the required authorized health care and research personnel.
The CAMUS trial is studying the outcomes using herbal therapy for benign prostatic
 hyperplasia (BPH).

 BPH is a common problem for older men. With BPH, the prostate grows larger. Over time, this
 growth can cause bothersome urinary symptoms. These symptoms can include frequent and/or
 urgent urination during the day or at night. Men with BPH can also have a weak urine stream,
 a stream that stops and starts, a feeling of not emptying the bladder all the way, and/or a
 need to strain to get urination started. BPH is NOT the same as prostate cancer.

 A number of natural products (extracts of different plants) seem to be able to reduce the
 bothersome symptoms of BPH with very few side effects over a few months. One of the plant
 extracts comes from the dwarf palm tree (Saw palmetto). The investigators do not know whether
 these plant extracts will reduce the symptoms of BPH over a longer period of treatment.
Inclusion Criteria:

 To be eligible for the study, potential participants must meet all of the following
 eligibility criteria:

 1. Male at least 45 years of age.

 2. Peak urinary flow rate at least 4 ml/sec with a voided volume of at least 125 ml.

 3. AUA symptom score ≥ 8 and ≤ 24 at both screening visits.

 4. Voluntarily signed informed consent agreement prior to the performance of any study
 procedures.

 Exclusion Criteria:

 Potential participants that meet any of the following exclusion criteria will be excluded
 from the full-scale trial:

 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.