A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
- Conditions
- Urinary Bladder OveractiveOveractive BladderUrinary Bladder DiseasesUrologic Diseases
- Interventions
- Drug: antimuscarinic medication
- Registration Number
- NCT02386072
- Lead Sponsor
- Astellas Scientific & Medical Affairs, Inc.
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1524
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2. patients diagnosed with OAB taking an antimuscarinic antimuscarinic medication patients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice 1. patients diagnosed with OAB taking mirabegron mirabegron patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice
- Primary Outcome Measures
Name Time Method Change from baseline in OAB-related QoL and symptom bother Baseline, Month 1, 3, 6 and 12 Overactive Bladder (OAB), Quality of Life (QoL). As measured by the Overactive Bladder Questionnaire Short Form (OAB-Q-SF) questionnaire scores
- Secondary Outcome Measures
Name Time Method Effectiveness as measured by general health related QoL Baseline, Month 1, 3, 6 and 12 via the EuroQol 5D \[EQ-5D\]
Persistence with OAB drug treatment Baseline till End of Study (ESV) (up to month 12) The duration of time a patient continues to take the prescribed medication
Switching of medication Baseline till ESV (up to month 12) As reported by patients and HCP
OAB drug treatment satisfaction Baseline, month 1, 3, 6 and 12 Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)
Reasons for switching of medication Baseline till ESV (up to month 12) As reported by patients and HCP for each specific medication, number and percent
Reasons for add-on medication Baseline till ESV (up to month 12) As reported by patients and HCP for each specific medication, number and percent
Reasons for dose titration Baseline till ESV (up to month 12) As reported by patients and HCP for each specific medication
Safety profile as assessed by recording AEs and SAEs Baseline till ESV (up to month 12) Adverse Events (AEs), Serious Adverse Events (SAEs)
Effectiveness as measured by impression of severity of OAB Baseline, Month 1, 3, 6 and 12 Via the Patient Perception of Bladder Condition \[PPBC\]
Use of additional (add-on) medications Baseline till ESV (up to month 12) As reported by patients and HCP
Reasons for discontinuation of medication Baseline till ESV (up to month 12) As reported by patients and HCP for each specific medication, number and percent
Frequency of dose titration Baseline till ESV (up to month 12) As reported by patients and HCP for each specific medication
Trial Locations
- Locations (92)
Site CA1025
🇨🇦Oshawa, Ontario, Canada
Site US1060
🇺🇸Raleigh, North Carolina, United States
Site US1067
🇺🇸Houston, Texas, United States
Site US1010
🇺🇸Huntsville, Alabama, United States
Site US1050
🇺🇸Hialeah, Florida, United States
Site US1028
🇺🇸Phoenix, Arizona, United States
Site US1083
🇺🇸Tucson, Arizona, United States
Site US1035
🇺🇸Columbus, Georgia, United States
Site US1094
🇺🇸Birmingham, Alabama, United States
Site US1058
🇺🇸Annapolis, Maryland, United States
Site US1100
🇺🇸Tucson, Arizona, United States
Site US1077
🇺🇸Lafayette, Louisiana, United States
Site US1051
🇺🇸Birmingham, Alabama, United States
Site US1104
🇺🇸Sacramento, California, United States
Site US1032
🇺🇸Miami, Florida, United States
Site US1046
🇺🇸Lake Barrington, Illinois, United States
Site US1021
🇺🇸Downingtown, Pennsylvania, United States
Site US1020
🇺🇸Mobile, Alabama, United States
Site US1036
🇺🇸Mesa, Arizona, United States
Site US1006
🇺🇸Goodyear, Arizona, United States
Site US1082
🇺🇸Saint Louis, Missouri, United States
Site US1013
🇺🇸Santa Ana, California, United States
Site US1018
🇺🇸Miami, Florida, United States
Site US1048
🇺🇸North Miami Beach, Florida, United States
Site US1009
🇺🇸Marietta, Georgia, United States
Site US1016
🇺🇸Idaho Falls, Idaho, United States
Site CA1000
🇨🇦Victoria, British Columbia, Canada
Site US1075
🇺🇸Miami, Florida, United States
Site US1106
🇺🇸New York, New York, United States
Site US1097
🇺🇸Muncie, Indiana, United States
Site US1105
🇺🇸Saint Louis, Missouri, United States
Site US1099
🇺🇸Virginia Beach, Virginia, United States
Site US1045
🇺🇸Poughkeepsie, New York, United States
Site CA1095
🇨🇦Oshawa, Ontario, Canada
Site CA1023
🇨🇦London, Ontario, Canada
Site US1084
🇺🇸Sioux Falls, South Dakota, United States
Site CA1022
🇨🇦Burlington, Ontario, Canada
Site CA1066
🇨🇦Coquitlam, British Columbia, Canada
Site CA1014
🇨🇦Mississauga, Ontario, Canada
Site CA1101
🇨🇦Richmond Hill, Ontario, Canada
Site CA1029
🇨🇦Burlington, Ontario, Canada
Site CA1072
🇨🇦Kingston, Ontario, Canada
Site CA1027
🇨🇦Toronto, Ontario, Canada
Site CA1065
🇨🇦Ottawa, Ontario, Canada
Site CA1054
🇨🇦Scarborough, Ontario, Canada
Site CA1005
🇨🇦Sudbury, Ontario, Canada
Site CA1092
🇨🇦Toronto, Ontario, Canada
Site CA1038
🇨🇦Pointe-Claire, Quebec, Canada
Site US1040
🇺🇸Newburgh, New York, United States
Site US1093
🇺🇸Ocoee, Florida, United States
Site US1055
🇺🇸Pompano Beach, Florida, United States
Site US1042
🇺🇸Atlanta, Georgia, United States
Site US1090
🇺🇸Northglenn, Colorado, United States
Site US1102
🇺🇸Omaha, Nebraska, United States
Site US1061
🇺🇸Little Rock, Arkansas, United States
Site US1114
🇺🇸Little Rock, Arkansas, United States
Site US1017
🇺🇸Council Bluffs, Iowa, United States
Site US1068
🇺🇸Miami, Florida, United States
Site US1112
🇺🇸Garden Grove, California, United States
Site US1088
🇺🇸Burlington, Massachusetts, United States
Site US1079
🇺🇸Miami, Florida, United States
Site US1098
🇺🇸Miami, Florida, United States
Site US1019
🇺🇸Evansville, Indiana, United States
Site US1034
🇺🇸Evansville, Indiana, United States
Site US1062
🇺🇸Hamtramck, Michigan, United States
Site US1059
🇺🇸Fall River, Massachusetts, United States
Site US1076
🇺🇸Watertown, Massachusetts, United States
Site US1004
🇺🇸Myrtle Beach, South Carolina, United States
Site US1089
🇺🇸Worcester, Massachusetts, United States
Site US1039
🇺🇸Omaha, Nebraska, United States
Site US1052
🇺🇸Las Vegas, Nevada, United States
Site US1015
🇺🇸Clarksville, Tennessee, United States
Site US1047
🇺🇸Hazelwood, Missouri, United States
Site US1085
🇺🇸New Brunswick, New Jersey, United States
Site US1043
🇺🇸Las Vegas, Nevada, United States
Site US1008
🇺🇸Albuquerque, New Mexico, United States
Site US1001
🇺🇸Sicklerville, New Jersey, United States
Site US1096
🇺🇸Garden City, New York, United States
Site US1037
🇺🇸Fort Worth, Texas, United States
Site US1070
🇺🇸Providence, Rhode Island, United States
Site US1080
🇺🇸Houston, Texas, United States
Site US1086
🇺🇸Seattle, Washington, United States
Site US1012
🇺🇸Plano, Texas, United States
Site US1057
🇺🇸Katy, Texas, United States
Site US1031
🇺🇸Miami, Florida, United States
Site US1044
🇺🇸Miami, Florida, United States
Site US1064
🇺🇸Overland Park, Kansas, United States
Site US1111
🇺🇸New York, New York, United States
Site US1007
🇺🇸Hilliard, Ohio, United States
Site CA1026
🇨🇦Calgary, Alberta, Canada
Site US1071
🇺🇸Monroe, Wisconsin, United States
Site US1103
🇺🇸Buffalo, New York, United States