An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Completed

• Conditions: Benign Prostatic Hyperplasia; BPH
• Interventions: Drug: Hanmi Tams® Capsule

• Registration Number: NCT05422677
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2019-07-15
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2022-06
• Study First Submitted: 2022-06-12
• Study First Submitted QC: 2022-06-14
• Study First Posted: 2022-06-16
• Last Update Submitted: 2022-06-21
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4698

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single arm, single group(No interventional)	Hanmi Tams® Capsule	Observational

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hanmi Pharmaceutical Company Limited; 🇰🇷 Seoul, Korea, Republic of