Benign Prostatic Hyperplasia Clinical Trial
Official title:
Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.
The objective of the study is to confirm in a larger and less selected population ("real
life conditions") the positive risk-benefit balance observed with silodosin in double-blind,
randomised clinical trials.
The following aspects will be evaluated:
- the effects on lower urinary tract symptoms (LUTS), by means of the International
Prostate Symptoms Score (IPSS) questionnaire
- the effect on the most frequent and bothersome symptoms, by means of International
Continence Society (ICS)-male questionnaire
- the effects on Quality of Life (QoL) due to urinary symptoms
- the safety profile
- the adherence to therapy
- the patient satisfaction with treatment The effectiveness and safety of the drug will
be investigated also in different subgroups of subjects according to age, severity of
the disease, concomitant disease and medications.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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