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To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin succinate | 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 |
|---|---|---|
| To assess the improvement in urge incontinence, frequency,nocturia, and urgency | Weeks 1, 4, 8 and 12 | |
| Number of patients satisfied with treatment | Weeks 1, 4, 8 and 12 | |
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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 |
|---|---|---|---|---|---|---|
| Anchorage | Alaska | 99508 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19014833 | Background | Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramee C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011. | |
| 18423103 |
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| Assessment of efficacy |
| End of study |
| Evaluation of the safety and tolerability | Baseline to end of study |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Scottsdale | Arizona | 85258 | United States |
| Little Rock | Arkansas | 72211 | United States |
| Dinuba | California | 93618 | United States |
| Glendora | California | 91741 | United States |
| La Mesa | California | 91942 | United States |
| Los Angeles | California | 90017 | United States |
| Los Angeles | California | 90048 | United States |
| Los Angeles | California | 90057 | United States |
| Mission Hills | California | 91345 | United States |
| Modesto | California | 95350 | United States |
| San Bernadino | California | 92404 | United States |
| Torrance | California | 90505 | United States |
| Upland | California | 91786 | United States |
| Valley Village | California | 91607 | United States |
| Aurora | Colorado | 80012 | United States |
| Denver | Colorado | 80205 | United States |
| Denver | Colorado | 80220 | United States |
| Farmington | Connecticut | 06302 | 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 |
| Aventura | Florida | 33180 | United States |
| Clearwater | Florida | 33761 | United States |
| Clearwater | Florida | 33765 | United States |
| Daytona Beach | Florida | 32114 | United States |
| Gainesville | Florida | 32607 | United States |
| Margate | Florida | 33063 | United States |
| New Port Richey | Florida | 34652 | United States |
| Orange City | Florida | 32763 | United States |
| Orlando | Florida | 32803 | United States |
| Saint Augustine | Florida | 32086 | United States |
| Tallahassee | Florida | 32308 | United States |
| Alpharetta | Georgia | 30005 | United States |
| Atlanta | Georgia | 30342 | United States |
| Blue Ridge | Georgia | 30513 | United States |
| Boise | Idaho | 83702 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Centralia | Illinois | 62801 | United States |
| Chicago | Illinois | 60616 | United States |
| Kankakee | Illinois | 60901 | United States |
| Niles | Illinois | 60714 | United States |
| Evansville | Indiana | 47714 | United States |
| Indianapolis | Indiana | 46202 | United States |
| Jeffersonville | Indiana | 47130 | United States |
| Muncie | Indiana | 47303 | United States |
| Baltimore | Maryland | 21204 | United States |
| Garrison | Maryland | 21117 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63141 | United States |
| Las Vegas | Nevada | 89109 | United States |
| Edison | New Jersey | 08837 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Neptune City | New Jersey | 07753 | United States |
| West Orange | New Jersey | 07052 | United States |
| Albuquerque | New Mexico | 87108 | United States |
| Albany | New York | 12205 | United States |
| Albany | New York | 12206 | United States |
| Albany | New York | 12208 | United States |
| Bay Shore | New York | 11706 | United States |
| Brooklyn | New York | 11235 | United States |
| Garden City | New York | 11530 | United States |
| Lewiston | New York | 14092 | United States |
| New York | New York | 10021 | United States |
| Williamsville | New York | 14221 | United States |
| Cary | North Carolina | 27511 | United States |
| Concord | North Carolina | 28025 | United States |
| Hickory | North Carolina | 28601 | United States |
| Cincinnati | Ohio | 45212 | United States |
| Cincinnati | Ohio | 45220 | United States |
| Cleveland | Ohio | 44195 | United States |
| Bethany | Oklahoma | 73008 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Springfield | Oregon | 97411 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| Bethlehem | Pennsylvania | 18015 | United States |
| Media | Pennsylvania | 19063 | United States |
| Monroeville | Pennsylvania | 15146 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Philadelphia | Pennsylvania | 19115 | United States |
| Philadelphia | Pennsylvania | 19146 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Sellersville | Pennsylvania | 18760 | United States |
| Aiken | South Carolina | 29801 | United States |
| Charleston | South Carolina | 19406 | United States |
| Charleston | South Carolina | 29425 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Jefferson City | Tennessee | 37760 | United States |
| Arlington | Texas | 76017 | United States |
| Athens | Texas | 75751 | United States |
| Carrollton | Texas | 75010 | United States |
| Houston | Texas | 77024 | United States |
| San Antonio | Texas | 78238 | United States |
| Bountiful | Utah | 84010 | United States |
| Layton | Utah | 84041 | United States |
| Ogden | Utah | 84403 | United States |
| Alexandria | Virginia | 22304 | United States |
| Richmond | Virginia | 23294 | United States |
| Seattle | Washington | 98111 | United States |
| Spokane | Washington | 99202 | United States |
| Huntington | West Virginia | 25701 | United States |
| Madison | Wisconsin | 53717 | United States |
| Background |
| Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17. |
| 19366272 | Background | Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003. |
| 20129258 | Background | Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004. |
| 21293089 | Derived | Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250. |
| 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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