SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Study Overview
=================
Brief Summary
-----------------
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 Objective: 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.

Official Title
-----------------
Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
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 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Alfuzosin<br>* Alfuzosin 10mg Once Daily for 24 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function. |  | 24 weeks | 
| Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire |  | 24 weeks | 
| - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1) |  | 24 weeks | 
| -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life |  | 24 weeks |