Benign Prostatic Hyperplasia, BPH
Conditions
Keywords
Tamsulosin, BPH, Benign Prostatic Hyperplasia
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.
Interventions
DRUGHanmi Tams® Capsule
Hanmi Tams®, Once daily administered per the locally approved product information
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed