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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Collaborators: |
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: 2
Transurethral Needle Ablation (TUNA)
|
Device: Transurethral Needle Ablation (TUNA) Therapy
type of minimally invasive surgical therapy for BPH
|
|
Active Comparator: 3
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
|
|
Active Comparator: 1
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 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Study Chair: | Reginald Bruskewitz, M.D. | University of Wisconsin, Madison, WI |
More Information
| Responsible Party: | Kathryn Hirst/Coordinating Center Principal Investigator, George Washington University Biostatistics Center |
| ClinicalTrials.gov Identifier: | NCT00064649 History of Changes |
| Other Study ID Numbers: | MIST (terminated), 5 U01 DK060817 |
| Study First Received: | July 10, 2003 |
| Last Updated: | January 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
prostate benign disease TUNA TUMT medical therapy |
|
Prostatic Hyperplasia Hyperplasia Prostatic Diseases Genital Diseases, Male Pathologic Processes Alfuzosin Finasteride Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs 5-alpha Reductase Inhibitors Enzyme Inhibitors |