Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT01757769
Brief 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.
Study:
NCT01757769
Study Brief:
Protocol Section:
NCT01757769