The long-term objectives and specific aims of this proposal are to establish the University of Iowa Department of Urology and Preventive Medicine trials group as a Clinical Evaluation and Treatment Center (CETC) in a multi-institutional research consortium. The purpose of this consortium is to study the effect of phytotherapy using Sernoa repens (saw palmetto) and Pygeum africanum in men with benign prostatic hyperplasia (BPH). A large segment of the United States population uses phytotherapy for treatment of symptoms of BPH, yet there is little scientific data regarding long-term treatment with these agents. Our proposal here at the CETC will enroll 300 patients in this trial during the enrollment period and follow them for the duration of the trial for a minimum of four years and a maximum of six years. The primary outcome measure will be the clinical progression of BPH. The recruitment, marketing, and retention strategies outlined in the following sections will ensure this level of participation as well as maximize the center's ability to recruit minority populations. This center has all the clinical and laboratory support required as stated in the protocol. The following sections outline innovative methods to recruit a large number of men with BPH as well as multiple strategies to ensure long-term compliance and completion of all scheduled follow-up visits. In summary, this proposal outlines what we believe are the outstanding credentials of the University of Iowa Department of Urology and Preventive Medicine to serve as a Clinical Evaluation and Treatment Center for this multi-institutional clinical trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK063840-07S1
Application #
8147503
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2010-09-30
Project End
2011-09-29
Budget Start
2010-09-30
Budget End
2011-09-29
Support Year
7
Fiscal Year
2010
Total Cost
$98,880
Indirect Cost
Name
University of Iowa
Department
Urology
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
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