Benign prostatic hyperplasia (BPH) is the most common affliction of men over the age of 50. There has been a rapid increase in the use of alternative therapies and specifically, phytotherapuetic agents, to treat BPH. Published studies have focused on the relative efficacy, i.e. symptoms, urinary flow rate and nocturia and side effect profile of these therapies. To date, there have been no studies which have described the natural history of BPH progression in those who are treated with phytotherapeutic agents such as Serenoa repens (Saw palmetto berry) or Pygeurn africanum (African plum tree). Moreover, the natural history of BPH in various age and ethnic groups have been poorly characterized. The Prostate Canter and the The Center for Holistic Urology at The New York Presbyterian Hospital evaluates and treats an ethnically diverse group of more than 3,200 men per year with lower urinary tract symptoms secondary to BPH. It is well positioned to meet the recruitment and patient retention goals as a CETC in this important multi - center, 7 year trial. This trial will provide enormous insight into the progression of BPH and related symptoms in both an untreated population, i.e. placebo versus one treated with phytotherapeutic agents. This is of particular importance because efficacy can be truly determined only with an understanding of the untreated natural history of BPH. Our primary objective is to ascertain if Serenoa repens or Pygeum africanum delays or prevents the clinical progression of BPH. Patients will be classified as 1) Progression of disease as defined by one of the following: rise in baseline AUA Symptom Score of 4 points; urinary retention; incontinence; or recurrent urinary tract infections; 2) Crossover to known therapy, i.e. medical or invasive prior to clinical progression; 3) non - compliance with the coded medication treatment regimen including patients who elect watchful waiting or open - label phytotherapy. Secondary outcomes include comparative efficacy between Serenoa repens and Pygeum africanum as defined by symptoms and urodynamic measurements. Through this full scale BPH trial, we hope to ascertain: A) the effects, if any, of phytotherapeutic agents on the clinical progression of BPH, B) the optimal temporal intervention in the treatment of BPH, C) whether specific ethnic groups manifest various forms of BPH resulting in different rates of progression and differential response to therapy? and, D) whether concomitant prostate conditions such as prostatitis are effected by phytotherapeutic intervention for BPH?

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK063831-01
Application #
6587499
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2002-09-30
Project End
2009-03-31
Budget Start
2002-09-30
Budget End
2003-03-31
Support Year
1
Fiscal Year
2002
Total Cost
$135,000
Indirect Cost
Name
Columbia University (N.Y.)
Department
Urology
Type
Schools of Medicine
DUNS #
167204994
City
New York
State
NY
Country
United States
Zip Code
10032
Lee, Jeannette Y; Moore, Page; Kusek, John et al. (2014) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. J Altern Complement Med 20:48-52
Barry, Michael J; Cantor, Alan; Roehrborn, Claus G et al. (2013) Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J Urol 189:987-92
Andriole, Gerald L; McCullum-Hill, Christie; Sandhu, Gurdarshan S et al. (2013) The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. J Urol 189:486-92
Helfand, Brian T; Lee, Jeanette Y; Sharp, Victoria et al. (2012) Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol 188:2288-93
Barry, Michael J; Avins, Andrew L; Meleth, Sreelatha et al. (2011) Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology 78:550-4
Barry, Michael J; Meleth, Sreelatha; Lee, Jeannette Y et al. (2011) Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 306:1344-51
Helfand, Brian T; McVary, Kevin T; Meleth, Sreelatha et al. (2011) The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol 185:2223-8
Lee, Jeannette Y; Foster Jr, Harris E; McVary, Kevin T et al. (2011) Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med 17:469-72
Lee, Jeannette; Andriole, Gerald; Avins, Andrew et al. (2009) Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials 6:628-36