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Sponsors and Collaborators: |
Samsung Medical Center GlaxoSmithKline |
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Information provided by: | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00827814 |
Treatment of lower urinary tract symptoms due to benign prostate hyperplasia aims at improving patient quality of life by reducing symptom-related bother. Treatment of bladder outlet obstruction aims at relieving benign prostate hyperplasia complications, such as chronic renal failure, hydronephrosis, bladder diverticula, and acute and chronic retention of urine, but also aims at relieving lower urinary tract symptoms associated with detrusor dysfunction.
Increased bladder mass occurs as a consequence of bladder outlet obstruction in animals and patients, and relief of bladder outlet obstruction reverses an increased bladder mass. Whether increased bladder mass is not only a consequence of bladder outlet obstruction but also a relevant risk factor for the progression of lower urinary tract symptoms associated with benign prostate hyperplasia cannot be decided due to a lack of appropriate data, most likely because bladder wall thickness is not routinely measured in clinical studies and/or routine clinical practice. Despite this lack of data, many urologists feel that increased bladder mass should be prevented or decreased to reduce the occurrence of serious complications.
The possibility of using bladder wall thickness data as criteria for benign prostate hyperplasia intervention and as outcome criteria for benign prostate hyperplasia treatment has been proposed. Detrusor hypertrophy associated with bladder outlet obstruction can be imaged on suprapubic ultrasound, and bladder mass can be quantified from the evaluation of bladder wall thickness and bladder volume. Bladder wall hypertrophy has been found to be correlated with detrusor function.
Independent studies have shown that surgical treatment of benign prostatic obstruction results in a significant decrease of bladder mass. Preliminary data suggest the possibility that medical treatment with alpha-adrenergic antagonists might also produce a reduction of bladder wall hypertrophy.
The investigators assume that the prevention of benign prostate hyperplasia progression by alpha-adrenergic antagonists and 5 alpha reductase inhibitors may be result of bladder function protection. To our knowledge there have been no studies that evaluated the effects of a 5 alpha reductase inhibitors on bladder function. Therefore, the investigators plan to conduct a prospective trial evaluating the effects of 5 alpha reductase inhibitors on bladder function by the evaluation of bladder wall thickness and lower urinary tract symptoms.
Condition | Intervention | Phase |
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Benign Prostatic Hyperplasia |
Drug: Dutasteride |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Effect of Dutasteride on Bladder Wall Hypertrophy in Patients With Benign Prostatic Obstruction: A 24-Week Open-Label, Single-Arm Pilot Study |
Estimated Enrollment: | 50 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Dutasteride: Experimental |
Drug: Dutasteride
Dutasteride 0.5 mg od.
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Ages Eligible for Study: | 50 Years to 79 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kyu-Sung Lee, Ph.D | 82-2-3410-3554 | ksleedr@skku.edu |
Korea, Republic of | |
Samsung Medical Center | Recruiting |
Seoul, Korea, Republic of, 135-710 | |
Contact: Kyu-Sung Lee, Ph.D, MD 82-2-3410-3554 ksleedr@skku.edu |
Principal Investigator: | Kyu-Sung Lee, Ph.D | Samsung Medical Center |
Responsible Party: | Samsung Medical Center ( Kyu-Sung Lee/Professor ) |
Study ID Numbers: | SMC IRB 2006-06-022-001 |
Study First Received: | January 22, 2009 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00827814 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Dutasteride Pathological Conditions, Anatomical Hypertrophy Hyperplasia |
Prostatic Diseases Prostatic Hyperplasia Genital Diseases, Male |
Dutasteride Pathological Conditions, Anatomical Hypertrophy Hyperplasia Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Prostatic Diseases Prostatic Hyperplasia Enzyme Inhibitors Genital Diseases, Male Pharmacologic Actions |