Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

An Open, Non-Comparative, Multicenter Study on the Sexual Function Improvement Following Treatment With Alfuzosin in Patients With Benign Prostate Hyperplasia

Primary:

To assess improvement in ejaculation from baseline to the end of treatment (Week 12 or premature withdrawal) with Alfuzosin 10mg OD, using MSHQ score.

Secondary:

• To evaluate sexual function improvement
• To evaluate LUTS (Lower Uninary Tract Symptoms) improvement
• To evaluate the association between LUTS severity and sexual function.
• To assess the safety and the tolerability of Alfuzosin 10mg OD.

Inclusion Criteria:

• Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) diagnosed by the Investigator
• Patients with an I-PSS total score ≥ 8
• Patients sexually active as defined by at least one of the following activities in the last 4 weeks: intercourse, caressing, foreplay, masturbation

Exclusion Criteria:

• Patients with a known history of hepatic or severe renal insufficiency, unstable angina pectoris
• Patients who had a previous prostate surgery
• Patients who had a prostate biopsy or minimally invasive procedure within 6 months prior to inclusion
• Patients with a prostate surgery or minimally invasive procedure during the whole study period
• Patients with an active urinary tract infection or prostatitis
• Patients with a neuropathic bladder defined as a spinal injury consequence or related to a neurological disorder or a known residual volume ≥ 350 ml
• Patients with 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
• Patients with a history of postural hypotension or syncope
• Patients with a 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.