Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

Study Overview
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Brief Summary
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To collect under daily practice conditions, clinical data on the changes of sexual function when a new formulation of alfuzosin(Xatral XL® )is administered once daily in patients with lower urinary tract symptoms(LUTS) suggestive of prostatic hypertrophy

Official Title
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Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL) in Patients With Benign Prostatic Hypertrophy

Conditions
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BPH/LUTS/Sexual Functions

Intervention / Treatment
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* Drug: Alfuzosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male patients suffering from LUTS lasting 6months and over male patients aged 50 years old and over who has a continuous active partner Exclusion Criteria: Primary hypogonadism and neuropathy patients History of prostate surgery Patients with prostate cancer History of organ surgery or organ damage in pelvis History of myocardiac infarction, stroke, and life threatening arrythmia within last 6 months Patients with haematuria caused by other reasons except BPH Patients with uncontrolled hypertension in spite of treatment with antihypertensive agents History of a malignant tumor within last 5 years Patients who are currently controlled with other medication for erectile dysfunction Patients who have been administered with androgen or antiandrogen Patients who is treated for psychiatric disorder or depression Combination with other alpha1-blockers Patients previously not improved by an alpha1-blocker treatment Known hypersensitivity to the alfuzosin History of postural hypotension or syncope Hepatic insufficiency Unstable angina pectoris The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF and GEQ (Global Efficacy Question) |  | at intermediate visit (M1) and at end-point visit(M3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure and heart rate measure in sitting position |  | at each visit | 
| IPSS and Quality of Life Score |  | at intermediate visit (M1) and at end-point visit(M3) | 
| Maximum flow rate and post voiding residual urine |  | at end-point visit(M3) | 
| Spontaneous reported adverse events |  | During all the study period |