An Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

NCT05422677 | Completed

• 1 other identifier: HM-TAM-OS-02
• Study Type: observational
• Target: 4,698
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH; Benign Prostatic Hyperplasia

Keywords

Tamsulosin; BPH; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

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

  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.

  6 months

Study Arms (1)

single arm, single group(No interventional)

Observational

Drug: Hanmi Tams® Capsule

Interventions

Hanmi Tams® Capsule DRUG

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

single arm, single group(No interventional)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Benign Prostatic Hyperplasia

You may qualify if:

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

You may not qualify if:

• Patients for whom use of Hanmi Tams® is prohibited

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi Pharmaceutical Company Limited

Seoul, 05545, South Korea

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ji-yeon Hong

  Hanmi Pharmaceutical Company Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 16, 2022
• Study Start: July 15, 2019
• Primary Completion: August 24, 2021
• Study Completion: August 24, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)