The specific aim of this proposal is to determine the efficacy of 4 regimens of medical therapy in the treatment and prevention of disease progression of benign prostatic hyperplasia. The 4 regimens are: 1) doxazosin; 2) finasteride; 3) doxazosin + finasteride, and 4) placebo. As part of a large, double-blind, randomized, cooperative trial this Clinical Center will evaluate, treat, and closely monitor 200 male volunteers of all races. The patients will be recruited into the study over 2 years and monitored for an additional 4 years. Patient eligibility criteria require an age of 50 years or greater, a uroflow between 4 and 15 ml/sec, and an AUA symptom score index of 8 or greater. End points for analysis include the occurrence of urinary retention, renal insufficiency, urinary tract infection, incontinence, and increase in American Urological Association symptom score index. This Clinical Center will analyze further economic costs of the treatment arms in a double-blind manner. The cooperative protocol has been developed following a Pilot Study and is subject to modifications by the Steering Committee. This Clinical Center will submit protocol data expeditiously to the Data Coordinating Center which will implement procedures for data audit and quality control procedures.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK049880-03S1
Application #
2698227
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Project Start
1995-04-27
Project End
2002-03-31
Budget Start
1997-12-19
Budget End
1998-03-31
Support Year
3
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Maryland Baltimore
Department
Surgery
Type
Schools of Medicine
DUNS #
003255213
City
Baltimore
State
MD
Country
United States
Zip Code
21201
Kaplan, Steven A; Lee, Jeannette Y; O'Neill, Edward A et al. (2013) Prevalence of low testosterone and its relationship to body mass index in older men with lower urinary tract symptoms associated with benign prostatic hyperplasia. Aging Male 16:169-72
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
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
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