Prostatic Hyperplasia
Conditions
Brief summary
The aim of the study is to collect, under daily practice conditions, clinical data on the safety profile and the efficacy of a new formulation of alfuzosin administered once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).
Interventions
DRUGAlfuzosin
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Ambulatory patients suffering from Lower Urinary Tract Symptoms suggestive of Benign Prostatic Hyperplasia
Exclusion criteria
* Patients requiring Benign Prostatic Hyperplasia surgery immediately or within the 12 following months * Patients previously not improved by an alpha 1-blocker treatment * Patients whose urinary symptoms are satisfactorily controlled on other Benign Prostatic Hyperplasia medication (alpha 1-blockers and 5-ARI) * Known hypersensitivity to alfuzosin * History of postural hypotension or syncope * Combination with other alpha 1-blockers * Hepatic insufficiency * Unstable angina pectoris * Severe concomitant condition threatening life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous adverse events | — |
| Blood pressure and heart rate measured in sitting position | — |
| International Prostate Symptom Score (IPSS) and quality of life index | — |
| DAN-PSS sexual function score | — |
| PSA levels measured at baseline | — |
| Maximum flow rate and residual urine | — |
Outcome results
None listed