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
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)|
- 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
|Study Start Date:||May 2001|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|
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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.