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A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. patients diagnosed with OAB taking mirabegron | patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice |
| |
| 2. patients diagnosed with OAB taking an antimuscarinic | patients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mirabegron | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in OAB-related QoL and symptom bother | Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores | Baseline, Month 1, 3, 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness as measured by impression of severity of OAB | Via the Patient Perception of Bladder Condition [PPBC] | Baseline, Month 1, 3, 6 and 12 |
| Effectiveness as measured by general health related QoL |
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Inclusion Criteria:
Exclusion Criteria:
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Sites that include medical specialties involved in the treatment of OAB, such as general practice/internal medicine, nurse practitioners, obstetricians/ gynecologists, urologists, and uro-gynecologists
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Urology | Astellas Scientific & Medical Affairs, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site US1051 | Birmingham | Alabama | 35235 | United States | ||
| Site US1094 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31222714 | Derived | Carlson KV, Rovner ES, Nair KV, Deal AS, Kristy RM, Schermer CR. Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE). Adv Ther. 2019 Aug;36(8):1906-1921. doi: 10.1007/s12325-019-00994-7. Epub 2019 Jun 20. | |
| 29777865 |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| antimuscarinic medication | Drug | oral |
|
|
via the EuroQol 5D [EQ-5D]
| Baseline, Month 1, 3, 6 and 12 |
| Persistence with OAB drug treatment | The duration of time a patient continues to take the prescribed medication | Baseline till End of Study (ESV) (up to month 12) |
| Use of additional (add-on) medications | As reported by patients and HCP | Baseline till ESV (up to month 12) |
| Switching of medication | As reported by patients and HCP | Baseline till ESV (up to month 12) |
| OAB drug treatment satisfaction | Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S) | Baseline, month 1, 3, 6 and 12 |
| Reasons for switching of medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) |
| Reasons for discontinuation of medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) |
| Reasons for add-on medication | As reported by patients and HCP for each specific medication, number and percent | Baseline till ESV (up to month 12) |
| Reasons for dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) |
| Frequency of dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) |
| Safety profile as assessed by recording AEs and SAEs | Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline till ESV (up to month 12) |
| Birmingham |
| Alabama |
| 35242 |
| United States |
| Site US1010 | Huntsville | Alabama | 35801 | United States |
| Site US1020 | Mobile | Alabama | 36604 | United States |
| Site US1006 | Goodyear | Arizona | 85395 | United States |
| Site US1036 | Mesa | Arizona | 85206 | United States |
| Site US1028 | Phoenix | Arizona | 85018 | United States |
| Site US1100 | Tucson | Arizona | 85715 | United States |
| Site US1083 | Tucson | Arizona | 85741 | United States |
| Site US1114 | Little Rock | Arkansas | 72205 | United States |
| Site US1061 | Little Rock | Arkansas | 72212 | United States |
| Site US1112 | Garden Grove | California | 92844 | United States |
| Site US1104 | Sacramento | California | 95817 | United States |
| Site US1013 | Santa Ana | California | 92701 | United States |
| Site US1090 | Northglenn | Colorado | 80234 | United States |
| Site US1050 | Hialeah | Florida | 33012 | United States |
| Site US1068 | Miami | Florida | 33015 | United States |
| Site US1079 | Miami | Florida | 33144 | United States |
| Site US1031 | Miami | Florida | 33155 | United States |
| Site US1032 | Miami | Florida | 33155 | United States |
| Site US1044 | Miami | Florida | 33155 | United States |
| Site US1018 | Miami | Florida | 33173 | United States |
| Site US1098 | Miami | Florida | 33175 | United States |
| Site US1075 | Miami | Florida | 33185 | United States |
| Site US1048 | North Miami Beach | Florida | 33162 | United States |
| Site US1093 | Ocoee | Florida | 34761 | United States |
| Site US1055 | Pompano Beach | Florida | 33060 | United States |
| Site US1042 | Atlanta | Georgia | 30342 | United States |
| Site US1035 | Columbus | Georgia | 31909 | United States |
| Site US1009 | Marietta | Georgia | 30067 | United States |
| Site US1016 | Idaho Falls | Idaho | 83404 | United States |
| Site US1046 | Lake Barrington | Illinois | 60010 | United States |
| Site US1019 | Evansville | Indiana | 47714 | United States |
| Site US1034 | Evansville | Indiana | 47725 | United States |
| Site US1097 | Muncie | Indiana | 47304 | United States |
| Site US1017 | Council Bluffs | Iowa | 51503 | United States |
| Site US1064 | Overland Park | Kansas | 66210 | United States |
| Site US1077 | Lafayette | Louisiana | 70503 | United States |
| Site US1058 | Annapolis | Maryland | 21401 | United States |
| Site US1088 | Burlington | Massachusetts | 01805 | United States |
| Site US1059 | Fall River | Massachusetts | 02720 | United States |
| Site US1076 | Watertown | Massachusetts | 02472 | United States |
| Site US1089 | Worcester | Massachusetts | 01605 | United States |
| Site US1062 | Hamtramck | Michigan | 48212 | United States |
| Site US1047 | Hazelwood | Missouri | 63042 | United States |
| Site US1082 | St Louis | Missouri | 63128 | United States |
| Site US1105 | St Louis | Missouri | 63141 | United States |
| Site US1102 | Omaha | Nebraska | 68114 | United States |
| Site US1039 | Omaha | Nebraska | 68124 | United States |
| Site US1043 | Las Vegas | Nevada | 89128 | United States |
| Site US1052 | Las Vegas | Nevada | 89146 | United States |
| Site US1085 | New Brunswick | New Jersey | 08901 | United States |
| Site US1001 | Sicklerville | New Jersey | 08081 | United States |
| Site US1008 | Albuquerque | New Mexico | 87106 | United States |
| Site US1103 | Buffalo | New York | 14203 | United States |
| Site US1096 | Garden City | New York | 11530 | United States |
| Site US1106 | New York | New York | 10003 | United States |
| Site US1111 | New York | New York | 10065 | United States |
| Site US1040 | Newburgh | New York | 12550 | United States |
| Site US1045 | Poughkeepsie | New York | 12601 | United States |
| Site US1060 | Raleigh | North Carolina | 27609 | United States |
| Site US1007 | Hilliard | Ohio | 43026 | United States |
| Site US1021 | Downingtown | Pennsylvania | 19335 | United States |
| Site US1070 | Providence | Rhode Island | 02914 | United States |
| Site US1004 | Myrtle Beach | South Carolina | 29588 | United States |
| Site US1084 | Sioux Falls | South Dakota | 57104 | United States |
| Site US1015 | Clarksville | Tennessee | 37040 | United States |
| Site US1037 | Fort Worth | Texas | 76132 | United States |
| Site US1080 | Houston | Texas | 77043 | United States |
| Site US1067 | Houston | Texas | 77055 | United States |
| Site US1057 | Katy | Texas | 77450 | United States |
| Site US1012 | Plano | Texas | 75093 | United States |
| Site US1099 | Virginia Beach | Virginia | 23462 | United States |
| Site US1086 | Seattle | Washington | 98104 | United States |
| Site US1071 | Monroe | Wisconsin | 53566 | United States |
| Site CA1026 | Calgary | Alberta | T2V 4R6 | Canada |
| Site CA1066 | Coquitlam | British Columbia | V3K3P4 | Canada |
| Site CA1000 | Victoria | British Columbia | V8T2CL | Canada |
| Site CA1022 | Burlington | Ontario | L7NV3V2 | Canada |
| Site CA1029 | Burlington | Ontario | L7S 1W7 | Canada |
| Site CA1005 | Greater Sudbury | Ontario | P3E 379 | Canada |
| Site CA1072 | Kingston | Ontario | K7L357 | Canada |
| Site CA1023 | London | Ontario | N6A566 | Canada |
| Site CA1014 | Mississauga | Ontario | L4T 4J2 | Canada |
| Site CA1095 | Oshawa | Ontario | L1H 1G4 | Canada |
| Site CA1025 | Oshawa | Ontario | L1H1G6 | Canada |
| Site CA1065 | Ottawa | Ontario | K1Y4E9 | Canada |
| Site CA1101 | Richmond Hill | Ontario | L4C 1T9 | Canada |
| Site CA1054 | Scarborough Village | Ontario | M1R3A6 | Canada |
| Site CA1027 | Toronto | Ontario | M2J2K9 | Canada |
| Site CA1092 | Toronto | Ontario | M5T2S8 | Canada |
| Site CA1038 | Pointe-Claire | Quebec | H9R4S3 | Canada |
| Rovner ES, Carlson KV, Deal AS, Nair KV, Oakkar EE, Park J, Gemmen E, Kristy RM, Gooch KL, Schermer CR. A Prospective, non-intErventional Registry Study of PatiEnts initiating a Course of drug Therapy for overactIVE bladder (PERSPECTIVE): Rationale, design, and methodology. Contemp Clin Trials. 2018 Jul;70:83-87. doi: 10.1016/j.cct.2018.05.006. Epub 2018 May 16. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C520025 | mirabegron |
| D000068737 | Tolterodine Tartrate |
| C005419 | oxybutynin |
| C101207 | darifenacin |
| C003330 | trospium chloride |
| D000069464 | Solifenacin Succinate |
| C526675 | fesoterodine |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
| 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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