Abstract

The proposal is a response for a research project (cooperative agreement) by the NIH-NIDDK for consideration for one of 10 Clinical Evaluation and Treatment Centers (CETC) forming a consortium to develop and conduct a randomized placebo controlled trial to evaluate whether the use of Saw palmetto (SP) or Pygeum africanum (PA) can prevent the progression of BPH. Health Relatedness: BPH is the most common neoplastic condition afflicting men and constitutes a major factor impacting Americans. Current studies estimate 30% of American males will require a surgical procedure to correct this problem sometime in their life. Increasing attention has been paid to plant extracts (or phytotherapy) use by patients to self-treat medical ailments such as BPH. Until more appropriately conducted trials are undertaken, the efficacy of phytotherapeutic agents will remain unproven. This study will be crucial to answering that question as well as others pertaining to the progression of BPH.
Specific Aims : The primary aim of this study is to address whether SP or PA alter BPH progression or simply delay the time to surgical therapy. The data accumulated should provide evidence regarding long term effects of these therapies on objective parameters of BPH including the AUA symptom score, maximal urinary flow rates, or prostate size and how these medications compare in their impact on the same. Design and Method: In three treatment arms 1000 patients with symptoms of BPH will be assigned to either SP, PA or placebo and followed for 4-6 years. Progression parameters will include: 1) changes in the AUA symptom score, 2) urinary retention, 3) recurrent UTI, 4) renal insufficiency, 5) urinary incontinence or 6) crossover to known therapy. Objective parameters of BPH will include prostate size, maximal urinary flow rates, and AUA symptom score. Secondary Aim: Unique to this submission is whether a chief complaint analysis, sleep scale measures or direct/indirect healthcare costs analysis provides reliable or useful information.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK063866-06
Application #
7418363
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2002-09-30
Project End
2010-03-31
Budget Start
2008-04-01
Budget End
2009-03-31
Support Year
6
Fiscal Year
2008
Total Cost
$136,949
Indirect Cost

  Institution

Name
Northwestern University at Chicago
Department
Urology
Type
Schools of Medicine
DUNS #
005436803
City
Chicago
State
IL
Country
United States
Zip Code
60611

  Publications

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
Cakir, Omer Onur; McVary, Kevin T (2012) LUTS and sleep disorders: emerging risk factor. Curr Urol Rep 13:407-12
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
McVary, Kevin T (2011) Sleep disturbances and lower urinary tract symptoms. Curr Urol Rep 12:243-4
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

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