Clinical trial NCT02386072: A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
Official title: A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Bladder Overactive
Overactive Bladder
Urinary Bladder Diseases
Urologic Diseases
Keywords: Betanis®
Myrbetriq®
Quality of Life
Antimuscarinics
Betmiga®
Overactive Bladder
Observational
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-03-11
Enrollment: 1524
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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)


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in OAB-related QoL and symptom bother
timeFrame: Baseline, Month 1, 3, 6 and 12
Secondary outcomes:
measure: Effectiveness as measured by impression of severity of OAB
timeFrame: Baseline, Month 1, 3, 6 and 12
measure: Effectiveness as measured by general health related QoL
timeFrame: Baseline, Month 1, 3, 6 and 12
measure: Persistence with OAB drug treatment
timeFrame: Baseline till End of Study (ESV) (up to month 12)
measure: Use of additional (add-on) medications
timeFrame: Baseline till ESV (up to month 12)
measure: Switching of medication
timeFrame: Baseline till ESV (up to month 12)
measure: OAB drug treatment satisfaction
timeFrame: Baseline, month 1, 3, 6 and 12
measure: Reasons for switching of medication
timeFrame: Baseline till ESV (up to month 12)
measure: Reasons for discontinuation of medication
timeFrame: Baseline till ESV (up to month 12)
measure: Reasons for add-on medication
timeFrame: Baseline till ESV (up to month 12)
measure: Reasons for dose titration
timeFrame: Baseline till ESV (up to month 12)
measure: Frequency of dose titration
timeFrame: Baseline till ESV (up to month 12)
measure: Safety profile as assessed by recording AEs and SAEs
timeFrame: Baseline till ESV (up to month 12)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Site US1051
state: Alabama
city: Birmingham
country: United States
facility: Site US1094
state: Alabama
city: Huntsville
country: United States
facility: Site US1010
state: Alabama
city: Mobile
country: United States
facility: Site US1020
state: Alabama
city: Goodyear
country: United States
facility: Site US1006
state: Arizona
city: Mesa
country: United States
facility: Site US1036
state: Arizona
city: Phoenix
country: United States
facility: Site US1028
state: Arizona
city: Tucson
country: United States
facility: Site US1100
state: Arizona
city: Tucson
country: United States
facility: Site US1083
state: Arizona
city: Little Rock
country: United States
facility: Site US1114
state: Arkansas
city: Little Rock
country: United States
facility: Site US1061
state: Arkansas
city: Garden Grove
country: United States
facility: Site US1112
state: California
city: Sacramento
country: United States
facility: Site US1104
state: California
city: Santa Ana
country: United States
facility: Site US1013
state: California
city: Northglenn
country: United States
facility: Site US1090
state: Colorado
city: Hialeah
country: United States
facility: Site US1050
state: Florida
city: Miami
country: United States
facility: Site US1068
state: Florida
city: Miami
country: United States
facility: Site US1079
state: Florida
city: Miami
country: United States
facility: Site US1031
state: Florida
city: Miami
country: United States
facility: Site US1032
state: Florida
city: Miami
country: United States
facility: Site US1044
state: Florida
city: Miami
country: United States
facility: Site US1018
state: Florida
city: Miami
country: United States
facility: Site US1098
state: Florida
city: Miami
country: United States
facility: Site US1075
state: Florida
city: North Miami Beach
country: United States
facility: Site US1048
state: Florida
city: Ocoee
country: United States
facility: Site US1093
state: Florida
city: Pompano Beach
country: United States
facility: Site US1055
state: Florida
city: Atlanta
country: United States
facility: Site US1042
state: Georgia
city: Columbus
country: United States
facility: Site US1035
state: Georgia
city: Marietta
country: United States
facility: Site US1009
state: Georgia
city: Idaho Falls
country: United States
facility: Site US1016
state: Idaho
city: Lake Barrington
country: United States
facility: Site US1046
state: Illinois
city: Evansville
country: United States
facility: Site US1019
state: Indiana
city: Evansville
country: United States
facility: Site US1034
state: Indiana
city: Muncie
country: United States
facility: Site US1097
state: Indiana
city: Council Bluffs
country: United States
facility: Site US1017
state: Iowa
city: Overland Park
country: United States
facility: Site US1064
state: Kansas
city: Lafayette
country: United States
facility: Site US1077
state: Louisiana
city: Annapolis
country: United States
facility: Site US1058
state: Maryland
city: Burlington
country: United States
facility: Site US1088
state: Massachusetts
city: Fall River
country: United States
facility: Site US1059
state: Massachusetts
city: Watertown
country: United States
facility: Site US1076
state: Massachusetts
city: Worcester
country: United States
facility: Site US1089
state: Massachusetts
city: Hamtramck
country: United States
facility: Site US1062
state: Michigan
city: Hazelwood
country: United States
facility: Site US1047
state: Missouri
city: Saint Louis
country: United States
facility: Site US1082
state: Missouri
city: Saint Louis
country: United States
facility: Site US1105
state: Missouri
city: Omaha
country: United States
facility: Site US1102
state: Nebraska
city: Omaha
country: United States
facility: Site US1039
state: Nebraska
city: Las Vegas
country: United States
facility: Site US1043
state: Nevada
city: Las Vegas
country: United States
facility: Site US1052
state: Nevada
city: New Brunswick
country: United States
facility: Site US1085
state: New Jersey
city: Sicklerville
country: United States
facility: Site US1001
state: New Jersey
city: Albuquerque
country: United States
facility: Site US1008
state: New Mexico
city: Buffalo
country: United States
facility: Site US1103
state: New York
city: Garden City
country: United States
facility: Site US1096
state: New York
city: New York
country: United States
facility: Site US1106
state: New York
city: New York
country: United States
facility: Site US1111
state: New York
city: Newburgh
country: United States
facility: Site US1040
state: New York
city: Poughkeepsie
country: United States
facility: Site US1045
state: New York
city: Raleigh
country: United States
facility: Site US1060
state: North Carolina
city: Hilliard
country: United States
facility: Site US1007
state: Ohio
city: Downingtown
country: United States
facility: Site US1021
state: Pennsylvania
city: Providence
country: United States
facility: Site US1070
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Site US1004
state: South Carolina
city: Sioux Falls
country: United States
facility: Site US1084
state: South Dakota
city: Clarksville
country: United States
facility: Site US1015
state: Tennessee
city: Fort Worth
country: United States
facility: Site US1037
state: Texas
city: Houston
country: United States
facility: Site US1080
state: Texas
city: Houston
country: United States
facility: Site US1067
state: Texas
city: Katy
country: United States
facility: Site US1057
state: Texas
city: Plano
country: United States
facility: Site US1012
state: Texas
city: Virginia Beach
country: United States
facility: Site US1099
state: Virginia
city: Seattle
country: United States
facility: Site US1086
state: Washington
city: Monroe
country: United States
facility: Site US1071
state: Wisconsin
city: Calgary
country: Canada
facility: Site CA1026
state: Alberta
city: Coquitlam
country: Canada
facility: Site CA1066
state: British Columbia
city: Victoria
country: Canada
facility: Site CA1000
state: British Columbia
city: Burlington
country: Canada
facility: Site CA1022
state: Ontario
city: Burlington
country: Canada
facility: Site CA1029
state: Ontario
city: Kingston
country: Canada
facility: Site CA1072
state: Ontario
city: London
country: Canada
facility: Site CA1023
state: Ontario
city: Mississauga
country: Canada
facility: Site CA1014
state: Ontario
city: Oshawa
country: Canada
facility: Site CA1095
state: Ontario
city: Oshawa
country: Canada
facility: Site CA1025
state: Ontario
city: Ottawa
country: Canada
facility: Site CA1065
state: Ontario
city: Richmond Hill
country: Canada
facility: Site CA1101
state: Ontario
city: Scarborough
country: Canada
facility: Site CA1054
state: Ontario
city: Sudbury
country: Canada
facility: Site CA1005
state: Ontario
city: Toronto
country: Canada
facility: Site CA1027
state: Ontario
city: Toronto
country: Canada
facility: Site CA1092
state: Ontario
city: Pointe-Claire
country: Canada
facility: Site CA1038
state: Quebec
Study officials:
affiliation: Astellas Scientific & Medical Affairs, Inc.
name: Medical Director Urology
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.