Abstract

Lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction (BPO) are common in the aging male There are few well-designed, long term, multi-center, randomized clinical trials comparing the subjective and objective outcomes of physiotherapy of prostatic symptoms (POPS) AIM 1 To collaborate with a research consortium to design and conduct a multi-center randomized phase III clinical trial comparing saw palmetto, Pygeum africanum, or a placebo for treatment of symptomatic BPH AIM 2 To recruit and randomize 300 men (in two years) with symptomatic BPH who meet the protocol guidelines AIM 3 To design and implement a prospective randomized controlled trial for treatment of BPH that will determine which of the following predict successful treatment outcomes patient characteristics, AUA symptoms score, uroflow rate, and prostate size AIM 4 To design and implement recruitment interventions among racial and ethnic minority men and procedures for the maintenance of the long-term participation of study subjects.

  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 #
5U01DK063833-06
Application #
7418221
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
$269,801
Indirect Cost

  Institution

Name
University of Colorado Denver
Department
Surgery
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045

  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
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