Benign Prostatic Hyperplasia in Taiwan

Study Overview
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Brief Summary
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Primary Objective: To assess the sexual function of Benign Prostatic Hyperplasia patients Secondary Objective: To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5) To assess the onset of action of XATRAL 10mg OD To assess the peak urinary flow rate To assess the safety and the tolerability of XATRAL 10mg OD

Official Title
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Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin

Conditions
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Prostatic Diseases

Intervention / Treatment
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* Drug: Alfuzosin (XATRAL® - SL770499)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) Sexually active Sexual attempts at least once per month Exclusion criteria Known history of hepatic or severe renal insufficiency unstable angina pectoris concomitant threatening-life condition Previous transurethral resection of the prostate (TURP) Had a minimally invasive procedure within 6 months prior to inclusion Planned prostate surgery or minimally invasive procedure during the whole study period Active urinary tract infection or acute prostatitis Neuropathic bladder Diagnosed prostate cancer Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion History of postural hypotension or syncope Known hypersensitivity to alfuzosin Patients illiterate or unable to understand or to complete the questionnaires Patients having participated in any clinical study in the past month Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer 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: 40 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>XATRAL 10mg OD | Drug: Alfuzosin (XATRAL® - SL770499)<br>* One tablet of XATRAL® 10mg OD once a day at the end of an evening meal. The tablets had to be swallowed whole without being chewed or crushed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Male Sexual Health Questionnaire Ejaculation score (MSHQ) |  | At week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSHQ Ejaculation score |  | At week 14, 12 and 24 | 
| International Prostate Symptom Score (I-PSS) including quality of life index |  | At week 1, 4, 12 and 24 | 
| Systolic and diastolic blood pressure |  | At week 1, 4, 12 and 24 | 
| Heart rate |  | At week 1, 4, 12 and 24 | 
| Prostate Specific Antigen |  | At week 24 |