This proposal provides detailed information on, and plans for, a clinical trial center in the Departments of Urology and Preventive Medicine at the University of Iowa for the full-scale trial of medical therapy in benign prostatic hyperplasia . The planning for this clinical trial center has been performed to ensure the center's success in meeting the long-term objectives of the multicenter trial. Specifically, this proposal provides detailed information to establish our ability to meet recruitment goals including minority populations, ensure eligibility of participants, perform accurate and efficient protocol follow-up, perform timely data entry and completion, effectively communicate with the data coordinating center and diagnostic center, and maintain patient interest and compliance. In order to ensure the ability of the clinical center to meet the above specific aims, a multi-disciplinary research team has been organized for this trial. Members of this team have been recruited based upon extensive prior experience in clinical research, expertise in the diagnosis, management and treatment of male voiding dysfunction, and well-established skills in patient recruitment for large-scale clinical trials. This core research team, in concert with additional study personnel, has been organized in an efficient administrative structure intended to meet the above specific aims. Through this structure, well-established and refined marketing strategies targeted at the desired patient population will be implemented to meet work accrual goals. Two satellite clinics in areas of higher density minority populations will enhance our ability to recruit these patients as well as broaden the catchment area through which we might access participants. Fail-safe mechanisms are outlined which are intended to ensure our ability to meet accrual goals, perform accurate and efficient follow-up, enter data in a timely fashion, and provide quality information to the data coordinating center. In addition, we have outlined our strategy for maintaining patient compliance throughout the protracted follow-up course of this trial. In summary, this proposal reviews both the qualifications of this clinical trial center, as well as the specific manner in which this center will function for the trial of medical therapy in benign prostatic hyperplasia.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK049971-04
Application #
2684271
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Kusek, John W
Project Start
1995-04-27
Project End
2002-03-31
Budget Start
1998-07-24
Budget End
1999-03-31
Support Year
4
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Iowa
Department
Urology
Type
Schools of Medicine
DUNS #
041294109
City
Iowa City
State
IA
Country
United States
Zip Code
52242
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Kaplan, Steven A; Lee, Jeannette Y; Meehan, Alan G et al. (2011) Long-term treatment with finasteride improves clinical progression of benign prostatic hyperplasia in men with an enlarged versus a smaller prostate: data from the MTOPS trial. J Urol 185:1369-73
Kaplan, Steven A; Roehrborn, Claus G; McConnell, John D et al. (2008) Long-term treatment with finasteride results in a clinically significant reduction in total prostate volume compared to placebo over the full range of baseline prostate sizes in men enrolled in the MTOPS trial. J Urol 180:1030-2;discussion 1032-3
Ullrich, Philip M; Lutgendorf, Susan K; Kreder, Karl J (2007) Physiologic reactivity to a laboratory stress task among men with benign prostatic hyperplasia. Urology 70:487-91;discussion 491-2
Johnson 2nd, Theodore M; Burrows, Pamela K; Kusek, John W et al. (2007) The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. J Urol 178:2045-50;discussion 2050-1
Crawford, E David; Wilson, Shandra S; McConnell, John D et al. (2006) Baseline factors as predictors of clinical progression of benign prostatic hyperplasia in men treated with placebo. J Urol 175:1422-6; discussion 1426-7
Kaplan, Steven A; McConnell, John D; Roehrborn, Claus G et al. (2006) Combination therapy with doxazosin and finasteride for benign prostatic hyperplasia in patients with lower urinary tract symptoms and a baseline total prostate volume of 25 ml or greater. J Urol 175:217-20; discussion 220-1
Ullrich, Philip M; Lutgendorf, Susan K; Leserman, Jane et al. (2005) Stress, hostility, and disease parameters of benign prostatic hyperplasia. Psychosom Med 67:476-82
McConnell, John D; Roehrborn, Claus G; Bautista, Oliver M et al. (2003) The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 349:2387-98