To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH. To assess the safety of alfuzosin in this population and health care consumption.
Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal. Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
800
Successful voiding in initial period (using an active voiding trial)
No relapse during the 6 month treatment period
No need / indication for surgery during the initial or 6 month treatment periods
To assess the safety of alfuzosin in this population, and health care consumption
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