An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4698 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-08-24

Brief Summary

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In this study, BPH patients visited the institutions during the study period and the effectiveness and safety of the treatment of Tamsulosin(Hanmi Tams® Capsule) in real-practice.

During the routine medical visit, according to the investigator's judgment, with diagnosis that the Tamsulosin prescription is appropriate, and after deciding to start treatment, patients with BPH who agreed to participate in the study were administered Tamsulosin.

As this study is a non-interventional observational study, all subjects received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

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Detailed Description

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This study is a multicenter, prospective, non-interventional, observational study of men administering Tamsulosin(Hanmi Tams® Capsule) to treat BPH.

Data will be collected from patients receiving routine treatment at hospitals in South Korea. Each subject visit the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of Tamsulosin.

This study will approved by the institutions' IRBs and is in compliance with clinical research ethics regulations.

Conditions

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BPH Benign Prostatic Hyperplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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single arm, single group(No interventional)

Observational

Hanmi Tams® Capsule

Intervention Type DRUG

Hanmi Tams®, Once daily administered per the locally approved product information

Interventions

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Hanmi Tams® Capsule

Hanmi Tams®, Once daily administered per the locally approved product information

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male was diagnosed with Benign Prostatic Hyperplasia
* Those who first started taking Hanmi Tams®
* Those who voluntarily consented in writing to this study