Clinical trial NCT00603304: Complementary and Alternative Medicine for Urological Symptoms(CAMUS)
Official title: Complementary and Alternative Medicine for Urological Symptoms (CAMUS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urological
Keywords: Serenoa repens
Urological symptoms
hyperplasia
BPH
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Office of Dietary Supplements (ODS)
name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Cornell University
name: New York University
name: Kaiser Permanente
name: Northwestern University
name: Queen's University
name: University of Colorado, Denver
name: University of Iowa
name: University of Maryland
name: University of Texas
name: Washington University School of Medicine
name: Yale University
First posted: 2008-01-29
Enrollment: 369
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean and Standard Deviation of the Participant American Urological Association (AUA)Symptom Score Between Baseline and Week 72 for CAMUS Participants.
timeFrame: Baseline to 72 weeks
Secondary outcomes:
measure: Participants Global Assessments of Improvement and Satisfaction at End of Study.
timeFrame: Baseline to 72 weeks
measure: Benign Prostate Hyperplasia (BPH) Impact Index Score
timeFrame: Baseline to 72 weeks
measure: International Prostate Symptom Score Quality of Life (IPSS QOL) Score
timeFrame: Baseline to 72 weeks
measure: American Urological Association(AUA) Nocturia Item
timeFrame: Baseline to 72 weeks
measure: Peak Uroflow
timeFrame: Baseline to 72 weeks
measure: Post-void Residual
timeFrame: Baseline to 72 weeks
measure: Prostate Specific Antigen (PSA) Level
timeFrame: Baseline to 72 weeks
measure: International Index of Erectile Function (IIEF)Scale Score.
timeFrame: Baseline to 72 weeks
measure: Male Sexual Health Questionnaire - Ejaculatory Domain (MSHQ-EjD) Scale Score.
timeFrame: Baseline to 72 weeks.
measure: International Continence Society Male Incontinence Symptom (ICSmale IS) Score
timeFrame: Baseline to 72 weeks
measure: Jenkins Sleep Scale Score
timeFrame: Baseline to 72 weeks
measure: NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Pain Scale
timeFrame: Baseline to 72 weeks
measure: NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Urinary Symptom Scale
timeFrame: Baseline to 72 weeks
measure: NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) Quality of Life (QOL)Scale
timeFrame: Baseline to 72 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Division of Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: Dallas
country: United States
facility: University of Texas - Southwestern Medical Center
state: Texas
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Massachusetts General Hospital
name: Michael Barry, MD
role: STUDY_CHAIR
affiliation: The University of Alabama at Birmingham
name: Alan Cantor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee J, Andriole G, Avins A, Crawford ED, Foster H, Kaplan S, Kreder K, Kusek J, McCullough A, McVary K, Meleth S, Naslund M, Nickel JC, Nyberg L, Roehrborn C, Dale Williams O, Barry M. Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials. 2009 Dec;6(6):628-36. doi: 10.1177/1740774509352199. Epub 2009 Dec 9.
citation: Lee JY, Foster HE Jr, McVary KT, Meleth S, Stavris K, Downey J, Kusek JW. Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med. 2011 May;17(5):469-72. doi: 10.1089/acm.2010.0300. Epub 2011 May 9.
citation: Barry MJ, Avins AL, Meleth S; Complementary and Alternative Medicine for Urological Symptoms Study Group. Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology. 2011 Sep;78(3):550-4. doi: 10.1016/j.urology.2011.04.017. Epub 2011 Jul 8.
citation: Helfand BT, McVary KT, Meleth S, Sharp V, Foster H, Naslund M, Williams OD; CAMUS Study Group. The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol. 2011 Jun;185(6):2223-8. doi: 10.1016/j.juro.2011.02.012. Epub 2011 Apr 17.
citation: Barry MJ, Meleth S, Lee JY, Kreder KJ, Avins AL, Nickel JC, Roehrborn CG, Crawford ED, Foster HE Jr, Kaplan SA, McCullough A, Andriole GL, Naslund MJ, Williams OD, Kusek JW, Meyers CM, Betz JM, Cantor A, McVary KT; Complementary and Alternative Medicine for Urological Symptoms (CAMUS) Study Group. Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA. 2011 Sep 28;306(12):1344-51. doi: 10.1001/jama.2011.1364.
citation: Helfand BT, Lee JY, Sharp V, Foster H, Naslund M, Williams OD, McVary KT; CAMUS Study Group. Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol. 2012 Dec;188(6):2288-93. doi: 10.1016/j.juro.2012.07.104. Epub 2012 Oct 22.