Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Study Overview
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Brief Summary
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Primary objective: End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD. Secondary objectives: MSHQ-EjD improvement by visit Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit Onset of action of XATRAL 10mg OD Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

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

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 LUTS suggestive of BPH I-PSS total score ≥ 8 Patients sexually active Exclusion criteria: Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening 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 Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-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
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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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Alfuzosin for 24 weeks | Drug: Alfuzosin<br>* One tablet of 10mg once daily at the end of evening meal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSHQ Ejaculation score |  | End of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MSHQ Ejaculation score |  | After 4 weeks of treatment | 
| MSHQ Ejaculation score |  | After 12 weeks of treatment | 
| Acute Urinary Retention |  | End of treatment | 
| Correlation between MSHQ and IPSS |  | End of treatment | 
| I-PSS total score |  | After 1 week of treatment | 
| I-PSS total score |  | After 4 weeks of treatment | 
| I-PSS total score |  | After 12 weeks of treatment | 
| I-PSS total score |  | End of treatment | 
| IPSS total score decrease = 3 points |  | End of treatment | 
| IPSS: filling sub-score |  | After 1 week of treatment | 
| IPSS: filling sub-score |  | After 4 weeks of treatment | 
| IPSS: filling sub-score |  | After 12 weeks of treatment | 
| IPSS: filling sub-score |  | End of treatment | 
| IPSS: nocturia symptoms sub-score |  | After 1 week of treatment | 
| IPSS: nocturia symptoms sub-score |  | After 4 weeks of treatment | 
| IPSS: nocturia symptoms sub-score |  | After 12 weeks of treatment | 
| IPSS: nocturia symptoms sub-score |  | End of treatment | 
| IPSS: voiding sub-score |  | After 1 week of treatment | 
| IPSS: voiding sub-score |  | After 4 weeks of treatment | 
| IPSS: voiding sub-score |  | After 12 weeks of treatment | 
| IPSS: voiding sub-score |  | End of treatment | 
| MSHQ ejaculation: erection sub-score |  | After 4 weeks of treatment | 
| MSHQ ejaculation: erection sub-score |  | After 12 weeks of treatment | 
| MSHQ ejaculation: erection sub-score |  | End of treatment | 
| MSHQ ejaculation: satisfaction sub-score |  | After 4 weeks of treatment | 
| MSHQ ejaculation: satisfaction sub-score |  | After 12 weeks of treatment | 
| MSHQ ejaculation: satisfaction sub-score |  | End of treatment | 
| Quality of Life |  | After 4 weeks of treatment | 
| Quality of Life |  | After 12 weeks of treatment | 
| Quality of Life |  | End of treatment |