Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: ALFUZOSIN


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Non-Randomized
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 |
| --- | --- | --- |
| Mean change from baseline to the end of treatment in the MSHQ ejaculation total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline to 4 weeks in MSHQ ejaculation total score |  |  | 
| Mean change from baseline to 4 weeks and the end of treatment in MSHQ erection total score and in the satisfaction total score |  |  | 
| Mean change from baseline to 4 weeks and the end of treatment in MSHQ ejaculation questions, in the erection and satisfaction sub-scores |  |  | 
| Mean change from baseline to 4 weeks and the end of treatment in the I-PSS (International Prostate Symptom Score) total score and in the Quality of Life |  |  | 
| Mean change from baseline to 4 weeks and the end of treatment in I-PSS sub-scores for voiding, filling and nocturia symptoms |  |  | 
| Mean change from baseline to 4 weeks and the end of treatment in the peak urinary flow rate (Qmax) |  |  | 
| Correlation between MSHQ and IPSS |  |  | 
| Evaluation of adverse events, vital signs (blood pressure and heart rate in sitting position), PSA (Prostate Specific Antigen) and creatinine. |  |  |