Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin

• Registration Number: NCT02245555
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Study to describe Tamsulosin prescription characteristics in a representative population of patients on treatment for benign prostatic hyperplasia

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-12
• Status Verified: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1060

Inclusion Criteria

• Patients older than 21 years old diagnosed with benign prostatic hyperplasia (BPH), who require pharmacological treatment to relieve symptoms and improve their quality of life, according to physician's judgment. The study will include naïve patients and patients not responding to previous therapy who receive Secotex as alternative or complementary treatment. The decision to treat a patient with Tamsulosin must be based on the best standard accepted in the clinical practice and must be carried out following Secotex (Tamsulosin) prescription information

Exclusion Criteria

• Patients with known hypersensitivity to Tamsulosin or any of its ingredients, history of orthostatic hypotension or severe liver failure, or with any missing data required to complete the questionnaire are excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with benign prostatic hyperplasia	Tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 21 months