An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

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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Key information

Conditions

BPH Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

19 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

Patients for whom use of Hanmi Tams® is prohibited

Treatment and study plan

Hanmi Tams® Capsule

Drug

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

Primary outcomes

LUTS (Lower Tract Symptoms) improvement effect evaluated in patients with BPH symptoms after Tamsulosin treatment

Time frame: 6 months

To measure the level of LUTS (Lower Tract Symptoms), the IPSS was calculated.

: The International Prostate Symptom Score (IPSS) is used to assess the severity of LUTS (Lower Tract Symptoms) and to monitor disease progression.

The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more).

The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Observational Study to Evaluate the Effectiveness and Safety of the Treatment of Tamsulosin in Korean Adult Males Diagnosed With Benign Prostatic Hyperplasia

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Jun 16, 2022
Registry last updated: Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed