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| Sponsored by: |
Asan Medical Center |
| Information provided by: | Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT00696761 |
Purpose
Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.
It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.
| Condition | Intervention | Phase |
|
BPH |
Drug: alfuzosin |
Phase IV |
| ChemIDplus related topics: | Alfuzosin Alfuzosin hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
| Official Title: | The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility |
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2006 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
group1: Active Comparator
BOOI≥ 20, BCI≥ 100
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Drug: alfuzosin
10mg, once daily, 12months
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group2: Active Comparator
BOOI≥ 20, BCI<100
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Drug: alfuzosin
10mg, once daily, 12months
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group 3: Active Comparator
BOOI<20, BCI≥ 100)
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Drug: alfuzosin
10mg, once daily, 12months
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group 4: Active Comparator
BOOI<20, BCI<100
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Drug: alfuzosin
10mg, once daily, 12 months
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Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Asan Medical Center ( Myung-Soo Choo, Professor ) |
| Study ID Numbers: | L9990 |
| First Received: | June 11, 2008 |
| Last Updated: | June 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00696761 |
| Health Authority: | Korea: Food and Drug Administration |
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