• Mean change in the MSHQ Ejaculation score (sum of questions Q5 to Q12). [ Time Frame: Baseline to end of treatment ] [ Designated as safety issue: No ]
  

• 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 ]
  

Drug: Alfuzosin
Once daily at end of evening meals for 24 weeks

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.