Study to evaluate the therapeutic effect of tamsulosin and finasteride in symptomatic BPH patients, two medications indicated in BPH belonging to two different pharmacological classes, as evaluated from the point of view of patient's perception of his pathological condition and of the impact of the disease on general health and quality of life
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
403
Change from baseline in Symptom Problem Index (SPI) by means of validated patient questionnaire
Time frame: Baseline, after 26 weeks of treatment
Change in Symptom Problem Index (SPI) - by means of validated patient questionnaire
Time frame: up to 52 weeks
Change in International Prostatic Symptom Score (IPSS)
questionnaire for the self-evaluation of urinary symptoms
Time frame: up to 52 weeks
Change in Qmax by means of free flow uroflowmetry
Time frame: up to 52 weeks
Number of patients who withdrew due to inefficacy
Time frame: up to 52 weeks
Number of patients with adverse events
Time frame: up to 54 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 52 weeks
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