NCT00696761

The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 232 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

1. Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility 2. Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity \& frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)

Conditions

• BPH

Interventions

Type	Name	Description
DRUG	Alfuzosin	10mg, once daily, 12months
DRUG	Alfuzosin	10mg, once daily, 12months
DRUG	Alfuzosin	10mg, once daily, 12months
DRUG	Alfuzosin	10mg, once daily, 12months

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2008-06-13
• Last updated: 2021-02-17
• Results posted: 2014-03-04