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| Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Diagnostic Ultrasound Urologix Medtronic Merck Sanofi-Synthelabo |
| Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00064649 |
Purpose
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 |
|
Benign Prostatic Hyperplasia |
Device: Transurethral Microwave Thermotherapy (TUMT) Device: Transurethral Needle Ablation (TUNA) Therapy Drug: Finasteride and Alfuzosin |
Phase III |
| ChemIDplus related topics: | Finasteride Alfuzosin Alfuzosin hydrochloride |
| 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 |
|
2: Active Comparator
Transurethral Needle Ablation (TUNA)
|
Device: Transurethral Needle Ablation (TUNA) Therapy
type of minimally invasive surgical therapy for BPH
|
|
3: Active Comparator
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
|
Drug: Finasteride and Alfuzosin
finasteride in a daily dose of 5 mg and alfuzosin in a daily dose of 10 mg
|
|
1: Active Comparator
Transurethral Microwave Thermotherapy (TUMT)
|
Device: Transurethral Microwave Thermotherapy (TUMT)
type of minimally invasive surgical therapy for BPH
|
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion
Exclusion
Contacts and Locations| 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 | |||||
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Diagnostic Ultrasound |
| Urologix |
| Medtronic |
| Merck |
| Sanofi-Synthelabo |
| Study Chair: | Reginald Bruskewitz, M.D. | University of Wisconsin, Madison, WI |
More Information
| Responsible Party: | George Washington University Biostatistics Center ( Kathryn Hirst/Coordinating Center Principal Investigator ) |
| Study ID Numbers: | MIST, 5 U01 DK060817 |
| First Received: | July 10, 2003 |
| Last Updated: | December 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00064649 |
| Health Authority: | United States: Food and Drug Administration |
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