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| Name | Class |
|---|---|
| Astellas Pharma Korea, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.
This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.tamsulosin + solifenacin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with "add-on" solifenacin treatment | Weeks of 12, 24 and 52 of combination therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in micturition efficacy parameters | Weeks of 12, 24 and 52 of combination therapy |
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Inclusion Criteria:
IPSS ≥ 12
Symptoms of OAB as verified by the V8 (≥8)
Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Sung Lee, MD | University School of Medicine, Kangnan-ku, Seoul, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cheonju | South Korea | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25363606 | Derived | Lee HN, Lee KS, Kim JC, Chung BH, Kim CS, Lee JG, Kim DK, Park CH, Park JK, Hong SJ. Rate and associated factors of solifenacin add-on after tamsulosin monotherapy in men with voiding and storage lower urinary tract symptoms. Int J Clin Pract. 2015 Apr;69(4):444-53. doi: 10.1111/ijcp.12581. Epub 2014 Nov 1. |
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| Choongju |
| South Korea |
| Daegu | South Korea |
| Daejeon | South Korea |
| Kangneung | South Korea |
| Kwangju | South Korea |
| Pusan | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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