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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Diagnostic Ultrasound Urologix Medtronic Merck Sanofi-Synthelabo |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00064649 |
The primary objective of this randomized clinical trial is to determine the efficacy and safety of three treatments for benign prostatic hyperplasia (BPH): transurethral needle ablation (TUNA), transurethral microwave therapy (TUMT), and medical therapy with alfuzosin and finasteride.
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Device: Transurethral Microwave Thermotherapy (TUMT) Device: Transurethral Needle Ablation (TUNA) Therapy Drug: Finasteride and Alfuzosin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Minimally Invasive Surgical Therapy Consortium for Benign Prostatic Hyperplasia |
Enrollment: | 49 |
Study Start Date: | April 2004 |
Study Completion Date: | June 2006 |
Arms | Assigned Interventions |
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2: Active Comparator
Transurethral Needle Ablation (TUNA)
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Device: Transurethral Needle Ablation (TUNA) Therapy
type of minimally invasive surgical therapy for BPH
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3: Active Comparator
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
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Drug: Finasteride and Alfuzosin
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
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1: Active Comparator
Transurethral Microwave Thermotherapy (TUMT)
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Device: Transurethral Microwave Thermotherapy (TUMT)
type of minimally invasive surgical therapy for BPH
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80010 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Columbia University | |
New York, New York, United States, 10032 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | Reginald Bruskewitz, M.D. | University of Wisconsin, Madison, WI |
Responsible Party: | George Washington University Biostatistics Center ( Kathryn Hirst/Coordinating Center Principal Investigator ) |
Study ID Numbers: | MIST, 5 U01 DK060817 |
Study First Received: | July 10, 2003 |
Last Updated: | December 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00064649 |
Health Authority: | United States: Food and Drug Administration |
prostate benign disease TUNA TUMT medical therapy |
Finasteride Hyperplasia Alfuzosin |
Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Neurotransmitter Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Adrenergic Antagonists Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Pharmacologic Actions |