• Mean change in MSHQ Ejaculation score [ Time Frame: Baseline to 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
• Mean change from baseline in MSHQ ejaculation questions (Q5 to Q12), in the erection and satisfaction sub-scores, in the IIEF-5 total score [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
• Correlation between MSHQ and IIEF-5 [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
• Mean change from baseline in I-PSS (International Prostate Score Symptom) total score and sub-scores (objective onset of action) [ Time Frame: week 1 ] [ Designated as safety issue: No ]
• Onset of action based on patient perception [ Time Frame: week 4 ] [ Designated as safety issue: No ]
• Mean change from baseline 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 [ Time Frame: 4, 12 and 24 weeks of treatment ] [ Designated as safety issue: No ]
• Percentage of patients with a IPSS total score decrease ≥ 3 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
• Percentage of patients with a IPSS total score increase ≥ 4 points [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
• Percentage of patients with Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH) surgery [ Time Frame: Baseline to end of study ] [ Designated as safety issue: No ]
• Risk factors for AUR or BPH surgery [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
• Correlation between MSHQ and IPSS [ Time Frame: baseline to end of study ] [ Designated as safety issue: No ]
• Comparison of mean change in sexual function, urinary symptoms and Quality of Life among the different regions [ Time Frame: From baseline to end of study ] [ Designated as safety issue: No ]
• Mean change from baseline of treatment in the peak urinary flow rate (Qmax) [ Time Frame: 1, 4, 12 and 24 weeks ] [ Designated as safety issue: No ]
• Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA and creatinine. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

• 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:

• To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary objectives:

• To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
• To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
• To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-item version of the International Index of Erectile Function),
• To assess the onset of action of XATRAL 10mg OD,
• To assess the peak flow rate improvement (Qmax)
• To assess the safety and the tolerability of XATRAL 10mg OD.

Inclusion criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
• Patients with an I-PSS total score ≥ 8,
• Patients sexually active.

Exclusion criteria:

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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
• Patients having received 5a-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or a1-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.