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The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VESIcare® | Drug | Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome | Weeks 1, 4, 8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of urgency | Weeks 1, 4, 8 and 12 | |
| Improvement of frequency, incontinence and nocturia | Weeks 1, 4, 8 and 12 | |
| Number of patients satisfied with treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma US, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85032 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18995887 | Background | Karram MM, Toglia MR, Serels SR, Andoh M, Fakhoury A, Forero-Schwanhaeuser S. Treatment with solifenacin increases warning time and improves symptoms of overactive bladder: results from VENUS, a randomized, double-blind, placebo-controlled trial. Urology. 2009 Jan;73(1):14-8. doi: 10.1016/j.urology.2008.08.485. Epub 2008 Nov 8. | |
| 19820284 |
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| placebo | Drug | Oral |
|
| Weeks 1, 4, 8 and 12 |
| Assessment of the efficacy | End of study |
| Evaluation of the safety and tolerability | Baseline to end of study |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Atherton | California | 94027 | United States |
| Carmichael | California | 95608 | United States |
| Escondido | California | 72025 | United States |
| Fresno | California | 93703 | United States |
| Los Angeles | California | 90057 | United States |
| Mission Hills | California | 91345 | United States |
| Mission Viejo | California | 92691 | United States |
| Salinas | California | 93901 | United States |
| Valley Village | California | 91607 | United States |
| Aurora | Colorado | 80012 | United States |
| Denver | Colorado | 80205 | United States |
| New London | Connecticut | 06320 | United States |
| Norwalk | Connecticut | 06850 | United States |
| Trumbull | Connecticut | 06611 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Washington D.C. | District of Columbia | 20017 | United States |
| Boyton Beach | Florida | 33347 | United States |
| Clearwater | Florida | 33761 | United States |
| Clearwater | Florida | 33765 | United States |
| Gainesville | Florida | 32607 | United States |
| Pembroke Pines | Florida | 33027 | United States |
| Plantation | Florida | 33324 | United States |
| Tallahassee | Florida | 32308 | United States |
| Alpharetta | Georgia | 30005 | United States |
| Atlanta | Georgia | 30342 | United States |
| Blue Ridge | Georgia | 30513 | United States |
| Marietta | Georgia | 30060 | United States |
| Boise | Idaho | 83702 | United States |
| Centralia | Illinois | 62801 | United States |
| Slidell | Louisiana | 70461 | United States |
| Bloomfield Hills | Michigan | 48302 | United States |
| Chesterfield | Missouri | 63017 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63128 | United States |
| Billings | Montana | 59102 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| South Bound Brook | New Jersey | 08880 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Albany | New York | 12205 | United States |
| East Syracuse | New York | 13057 | United States |
| Hewlett | New York | 11551 | United States |
| Lewiston | New York | 14092 | United States |
| New York | New York | 10021 | United States |
| Concord | North Carolina | 28025 | United States |
| Hickory | North Carolina | 28601 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Bismarck | North Dakota | 58501 | United States |
| Cincinnati | Ohio | 45220 | United States |
| Cleveland | Ohio | 44195 | United States |
| Eugene | Oregon | 97401 | United States |
| Endwell | Pennsylvania | 13760 | United States |
| Media | Pennsylvania | 19063 | United States |
| Monroeville | Pennsylvania | 15146 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Uniontown | Pennsylvania | 15401 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Athens | Texas | 75751 | United States |
| Ogden | Utah | 84403 | United States |
| West Point | Utah | 84015 | United States |
| Richmond | Virginia | 23294 | United States |
| Spokane | Washington | 99202 | United States |
| Vancouver | Washington | 98607 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Toglia MR, Serels SR, Laramee C, Karram MM, Nandy IM, Andoh M, Seifeldin R, Forero-Schwanhaeuser S. Solifenacin for overactive bladder: patient-reported outcomes from a large placebo-controlled trial. Postgrad Med. 2009 Sep;121(5):151-8. doi: 10.3810/pgm.2009.09.2062. |
| 37160401 | Derived | Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
| 20707767 | Derived | Serels SR, Toglia MR, Forero-Schwanhaeuser S, He W. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010 Oct;26(10):2277-85. doi: 10.1185/03007995.2010.509582. |
| 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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