Overactive Bladder Clinical Trial
— PERSPECTIVEOfficial title:
A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)
| NCT number | NCT02386072 |
| Other study ID # | 178-MA-1006 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 5, 2015 |
| Est. completion date | August 4, 2017 |
| Verified date | October 2018 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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)
| Status | Completed |
| Enrollment | 1524 |
| Est. completion date | August 4, 2017 |
| Est. primary completion date | August 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with OAB (with or without urgency incontinence) by the treating HCP, with symptoms for at least three months prior to study enrollment - Initiating a new course of treatment with mirabegron or antimuscarinic medication (including patch formulation) for OAB, which may be first course of any treatment for OAB, restart or switch from one drug to another - Willing and able to complete PRO questionnaires with minimal assistance Exclusion Criteria: - Current participation in clinical trials of OAB - Use of more than one OAB medication at time of enrollment - Patients whose OAB has been treated with onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment - Neurologic conditions associated with OAB symptoms - Patients residing in a nursing home |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Site CA1022 | Burlington | Ontario |
| Canada | Site CA1029 | Burlington | Ontario |
| Canada | Site CA1026 | Calgary | Alberta |
| Canada | Site CA1066 | Coquitlam | British Columbia |
| Canada | Site CA1072 | Kingston | Ontario |
| Canada | Site CA1023 | London | Ontario |
| Canada | Site CA1014 | Mississauga | Ontario |
| Canada | Site CA1025 | Oshawa | Ontario |
| Canada | Site CA1095 | Oshawa | Ontario |
| Canada | Site CA1065 | Ottawa | Ontario |
| Canada | Site CA1038 | Pointe-Claire | Quebec |
| Canada | Site CA1101 | Richmond Hill | Ontario |
| Canada | Site CA1054 | Scarborough | Ontario |
| Canada | Site CA1005 | Sudbury | Ontario |
| Canada | Site CA1027 | Toronto | Ontario |
| Canada | Site CA1092 | Toronto | Ontario |
| Canada | Site CA1000 | Victoria | British Columbia |
| United States | Site US1008 | Albuquerque | New Mexico |
| United States | Site US1058 | Annapolis | Maryland |
| United States | Site US1042 | Atlanta | Georgia |
| United States | Site US1051 | Birmingham | Alabama |
| United States | Site US1094 | Birmingham | Alabama |
| United States | Site US1103 | Buffalo | New York |
| United States | Site US1088 | Burlington | Massachusetts |
| United States | Site US1015 | Clarksville | Tennessee |
| United States | Site US1035 | Columbus | Georgia |
| United States | Site US1017 | Council Bluffs | Iowa |
| United States | Site US1021 | Downingtown | Pennsylvania |
| United States | Site US1019 | Evansville | Indiana |
| United States | Site US1034 | Evansville | Indiana |
| United States | Site US1059 | Fall River | Massachusetts |
| United States | Site US1037 | Fort Worth | Texas |
| United States | Site US1096 | Garden City | New York |
| United States | Site US1112 | Garden Grove | California |
| United States | Site US1006 | Goodyear | Arizona |
| United States | Site US1062 | Hamtramck | Michigan |
| United States | Site US1047 | Hazelwood | Missouri |
| United States | Site US1050 | Hialeah | Florida |
| United States | Site US1007 | Hilliard | Ohio |
| United States | Site US1067 | Houston | Texas |
| United States | Site US1080 | Houston | Texas |
| United States | Site US1010 | Huntsville | Alabama |
| United States | Site US1016 | Idaho Falls | Idaho |
| United States | Site US1057 | Katy | Texas |
| United States | Site US1077 | Lafayette | Louisiana |
| United States | Site US1046 | Lake Barrington | Illinois |
| United States | Site US1043 | Las Vegas | Nevada |
| United States | Site US1052 | Las Vegas | Nevada |
| United States | Site US1061 | Little Rock | Arkansas |
| United States | Site US1114 | Little Rock | Arkansas |
| United States | Site US1009 | Marietta | Georgia |
| United States | Site US1036 | Mesa | Arizona |
| United States | Site US1018 | Miami | Florida |
| United States | Site US1031 | Miami | Florida |
| United States | Site US1032 | Miami | Florida |
| United States | Site US1044 | Miami | Florida |
| United States | Site US1068 | Miami | Florida |
| United States | Site US1075 | Miami | Florida |
| United States | Site US1079 | Miami | Florida |
| United States | Site US1098 | Miami | Florida |
| United States | Site US1020 | Mobile | Alabama |
| United States | Site US1071 | Monroe | Wisconsin |
| United States | Site US1097 | Muncie | Indiana |
| United States | Site US1004 | Myrtle Beach | South Carolina |
| United States | Site US1085 | New Brunswick | New Jersey |
| United States | Site US1106 | New York | New York |
| United States | Site US1111 | New York | New York |
| United States | Site US1040 | Newburgh | New York |
| United States | Site US1048 | North Miami Beach | Florida |
| United States | Site US1090 | Northglenn | Colorado |
| United States | Site US1093 | Ocoee | Florida |
| United States | Site US1039 | Omaha | Nebraska |
| United States | Site US1102 | Omaha | Nebraska |
| United States | Site US1064 | Overland Park | Kansas |
| United States | Site US1028 | Phoenix | Arizona |
| United States | Site US1012 | Plano | Texas |
| United States | Site US1055 | Pompano Beach | Florida |
| United States | Site US1045 | Poughkeepsie | New York |
| United States | Site US1070 | Providence | Rhode Island |
| United States | Site US1060 | Raleigh | North Carolina |
| United States | Site US1104 | Sacramento | California |
| United States | Site US1082 | Saint Louis | Missouri |
| United States | Site US1105 | Saint Louis | Missouri |
| United States | Site US1013 | Santa Ana | California |
| United States | Site US1086 | Seattle | Washington |
| United States | Site US1001 | Sicklerville | New Jersey |
| United States | Site US1084 | Sioux Falls | South Dakota |
| United States | Site US1083 | Tucson | Arizona |
| United States | Site US1100 | Tucson | Arizona |
| United States | Site US1099 | Virginia Beach | Virginia |
| United States | Site US1076 | Watertown | Massachusetts |
| United States | Site US1089 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Scientific & Medical Affairs, Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | Effectiveness as measured by impression of severity of OAB | Via the Patient Perception of Bladder Condition [PPBC] | Baseline, Month 1, 3, 6 and 12 | |
| Secondary | Effectiveness as measured by general health related QoL | via the EuroQol 5D [EQ-5D] | Baseline, Month 1, 3, 6 and 12 | |
| Secondary | 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) | |
| Secondary | Use of additional (add-on) medications | As reported by patients and HCP | Baseline till ESV (up to month 12) | |
| Secondary | Switching of medication | As reported by patients and HCP | Baseline till ESV (up to month 12) | |
| Secondary | OAB drug treatment satisfaction | Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S) | Baseline, month 1, 3, 6 and 12 | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | Reasons for dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) | |
| Secondary | Frequency of dose titration | As reported by patients and HCP for each specific medication | Baseline till ESV (up to month 12) | |
| Secondary | Safety profile as assessed by recording AEs and SAEs | Adverse Events (AEs), Serious Adverse Events (SAEs) | Baseline till ESV (up to month 12) |
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