• MSHQ Ejaculation score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• MSHQ Ejaculation score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• Acute Urinary Retention [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• Correlation between MSHQ and IPSS [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• I-PSS total score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
• I-PSS total score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• I-PSS total score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• I-PSS total score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• IPSS total score decrease = 3 points [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• IPSS: filling sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
• IPSS: filling sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: filling sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: filling sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• IPSS: nocturia symptoms sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
• IPSS: nocturia symptoms sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: nocturia symptoms sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: nocturia symptoms sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• IPSS: voiding sub-score [ Time Frame: After 1 week of treatment ] [ Designated as safety issue: No ]
• IPSS: voiding sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: voiding sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• IPSS: voiding sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: erection sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: erection sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: erection sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: satisfaction sub-score [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• MSHQ ejaculation: satisfaction sub-score [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: After 12 weeks of treatment ] [ Designated as safety issue: No ]
• Quality of Life [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

• Mean change from baseline to 4 and 12 weeks of treatment in MSHQ Ejaculation score
• Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores, in the IIEF-5 total score
• Correlation between MSHQ and IIEF-5
• Mean change from baseline to week 1 in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action)
• Onset of action based on patient perception (question answered at Week 4)
• Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life (8th question of I-PSS), in IPSS sub-scores for voiding, filling and nocturia symptoms
• Percentage of patients with a IPSS total score decrease ≥ 3 points
• Percentage of patients with a IPSS total score increase ≥ 4 points
• Percentage of patients with Acute Urinary Retention (AUR) or Begnin Prostatic Hyperplasia (BPH) surgery
• Risk factors for AUR or BPH surgery
• Correlation between MSHQ and IPSS
• Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions
• Mean change from baseline to 1 week, 4 weeks, 12 weeks and 24 weeks (or PW) of treatment in the peak urinary flow rate (Qmax)
• Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine.

Primary objective:

• End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

• MSHQ-EjD improvement by visit
• Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
• Onset of action of XATRAL 10mg OD
• Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

Inclusion criteria:

• Patients suffering from moderate to severe LUTS suggestive of BPH
• I-PSS total score ≥ 8
• Patients sexually active

Exclusion criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
• Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
• Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
• Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
• Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
• History of postural hypotension or syncope
• Known hypersensitivity to alfuzosin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.