A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
PERSPECTIVE
A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)
1 other identifier
observational
1,524
2 countries
92
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Typical duration for all trials
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2015
CompletedFirst Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2017
CompletedOctober 16, 2024
October 1, 2018
2.6 years
March 6, 2015
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (12)
Effectiveness as measured by impression of severity of OAB
Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by general health related QoL
Baseline, Month 1, 3, 6 and 12
Persistence with OAB drug treatment
Baseline till End of Study (ESV) (up to month 12)
Use of additional (add-on) medications
Baseline till ESV (up to month 12)
Switching of medication
Baseline till ESV (up to month 12)
- +7 more secondary outcomes
Study Arms (2)
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
Interventions
oral
oral
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Site US1051
Birmingham, Alabama, 35235, United States
Site US1094
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
Related Publications (2)
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.
PMID: 31222714DERIVEDRovner 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.
PMID: 29777865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director Urology
Astellas Scientific & Medical Affairs, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 11, 2015
Study Start
January 5, 2015
Primary Completion
August 4, 2017
Study Completion
August 4, 2017
Last Updated
October 16, 2024
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share
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/.