ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male aged over 50 years
- Having given his written consent
- Presenting with a first episode of painful acute urinary retention related to BPH
- With a catheterized urine volume between mL and mL at the time of retention
Exclusion criteria
- Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
- Iatrogenic causes of urinary retention
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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