NCT01757769

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,036 (actual)
• Sponsor: RECORDATI GROUP · Industry
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Silodosin	8 mg daily for 24 weeks

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2012-12-31
• Last updated: 2014-04-29

Locations

1 site across 1 country: Italy