Conditions: BPH
Keywords: LUTS BPH bladder outlet obstruction bladder contractility
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 232
Healthy volunteers: no

Brief 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)

Arms:
arm 1: Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 2: BOOI≥ 20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month. arm 3: BOOI\<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month. arm 4: BOOI\<20, BCI\<100 Alfuzosin was administered daily (10 mg) for 12 month.

Interventions: intervention 1: Alfuzosin intervention 2: Alfuzosin intervention 3: Alfuzosin intervention 4: Alfuzosin
Intervention descriptions: intervention 1: 10mg, once daily, 12months intervention 2: 10mg, once daily, 12months intervention 3: 10mg, once daily, 12months intervention 4: 10mg, once daily, 12months

Protocol document: