A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB) (PERSPECTIVE)

October 18, 2018 updated by: Astellas Scientific & Medical Affairs, Inc.

A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1524

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2V 4R6
        • Site CA1026
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K3P4
        • Site CA1066
      • Victoria, British Columbia, Canada, V8T2CL
        • Site CA1000
    • Ontario
      • Burlington, Ontario, Canada, L7NV3V2
        • Site CA1022
      • Burlington, Ontario, Canada, L7S 1W7
        • Site CA1029
      • Kingston, Ontario, Canada, K7L357
        • Site CA1072
      • London, Ontario, Canada, N6A566
        • Site CA1023
      • Mississauga, Ontario, Canada, L4T 4J2
        • Site CA1014
      • Oshawa, Ontario, Canada, L1H 1G4
        • Site CA1095
      • Oshawa, Ontario, Canada, L1H1G6
        • Site CA1025
      • Ottawa, Ontario, Canada, K1Y4E9
        • Site CA1065
      • Richmond Hill, Ontario, Canada, L4C 1T9
        • Site CA1101
      • Scarborough, Ontario, Canada, M1R3A6
        • Site CA1054
      • Sudbury, Ontario, Canada, P3E 379
        • Site CA1005
      • Toronto, Ontario, Canada, M2J2K9
        • Site CA1027
      • Toronto, Ontario, Canada, M5T2S8
        • Site CA1092
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R4S3
        • Site CA1038
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Site US1051
      • Birmingham, Alabama, United States, 35242
        • Site US1094
      • Huntsville, Alabama, United States, 35801
        • Site US1010
      • Mobile, Alabama, United States, 36604
        • Site US1020
    • Arizona
      • Goodyear, Arizona, United States, 85395
        • Site US1006
      • Mesa, Arizona, United States, 85206
        • Site US1036
      • Phoenix, Arizona, United States, 85018
        • Site US1028
      • Tucson, Arizona, United States, 85715
        • Site US1100
      • Tucson, Arizona, United States, 85741
        • Site US1083
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Site US1114
      • Little Rock, Arkansas, United States, 72212
        • Site US1061
    • California
      • Garden Grove, California, United States, 92844
        • Site US1112
      • Sacramento, California, United States, 95817
        • Site US1104
      • Santa Ana, California, United States, 92701
        • Site US1013
    • Colorado
      • Northglenn, Colorado, United States, 80234
        • Site US1090
    • Florida
      • Hialeah, Florida, United States, 33012
        • Site US1050
      • Miami, Florida, United States, 33015
        • Site US1068
      • Miami, Florida, United States, 33144
        • Site US1079
      • Miami, Florida, United States, 33155
        • Site US1031
      • Miami, Florida, United States, 33155
        • Site US1032
      • Miami, Florida, United States, 33155
        • Site US1044
      • Miami, Florida, United States, 33173
        • Site US1018
      • Miami, Florida, United States, 33175
        • Site US1098
      • Miami, Florida, United States, 33185
        • Site US1075
      • North Miami Beach, Florida, United States, 33162
        • Site US1048
      • Ocoee, Florida, United States, 34761
        • Site US1093
      • Pompano Beach, Florida, United States, 33060
        • Site US1055
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Site US1042
      • Columbus, Georgia, United States, 31909
        • Site US1035
      • Marietta, Georgia, United States, 30067
        • Site US1009
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Site US1016
    • Illinois
      • Lake Barrington, Illinois, United States, 60010
        • Site US1046
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Site US1019
      • Evansville, Indiana, United States, 47725
        • Site US1034
      • Muncie, Indiana, United States, 47304
        • Site US1097
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Site US1017
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Site US1064
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Site US1077
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Site US1058
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Site US1088
      • Fall River, Massachusetts, United States, 02720
        • Site US1059
      • Watertown, Massachusetts, United States, 02472
        • Site US1076
      • Worcester, Massachusetts, United States, 01605
        • Site US1089
    • Michigan
      • Hamtramck, Michigan, United States, 48212
        • Site US1062
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Site US1047
      • Saint Louis, Missouri, United States, 63128
        • Site US1082
      • Saint Louis, Missouri, United States, 63141
        • Site US1105
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Site US1102
      • Omaha, Nebraska, United States, 68124
        • Site US1039
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Site US1043
      • Las Vegas, Nevada, United States, 89146
        • Site US1052
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Site US1085
      • Sicklerville, New Jersey, United States, 08081
        • Site US1001
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Site US1008
    • New York
      • Buffalo, New York, United States, 14203
        • Site US1103
      • Garden City, New York, United States, 11530
        • Site US1096
      • New York, New York, United States, 10003
        • Site US1106
      • New York, New York, United States, 10065
        • Site US1111
      • Newburgh, New York, United States, 12550
        • Site US1040
      • Poughkeepsie, New York, United States, 12601
        • Site US1045
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Site US1060
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Site US1007
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Site US1021
    • Rhode Island
      • Providence, Rhode Island, United States, 02914
        • Site US1070
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29588
        • Site US1004
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Site US1084
    • Tennessee
      • Clarksville, Tennessee, United States, 37040
        • Site US1015
    • Texas
      • Fort Worth, Texas, United States, 76132
        • Site US1037
      • Houston, Texas, United States, 77043
        • Site US1080
      • Houston, Texas, United States, 77055
        • Site US1067
      • Katy, Texas, United States, 77450
        • Site US1057
      • Plano, Texas, United States, 75093
        • Site US1012
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Site US1099
    • Washington
      • Seattle, Washington, United States, 98104
        • Site US1086
    • Wisconsin
      • Monroe, Wisconsin, United States, 53566
        • Site US1071

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1. patients diagnosed with OAB taking mirabegron
patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice
Drug: mirabegron
oral
Other Names:
  • YM178
  • Myrbetriq
  • Betanis
  • Betmiga
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
Drug: antimuscarinic medication
oral
Other Names:
  • Gelnique
  • Enablex
  • Vesicare
  • Detrol
  • Toviaz
  • Sanctura
  • Ditropan XL
  • Oxytrol
  • Trosec
  • Oxybutynin IR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in OAB-related QoL and symptom bother
Time Frame: 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
Baseline, Month 1, 3, 6 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness as measured by impression of severity of OAB
Time Frame: Baseline, Month 1, 3, 6 and 12
Via the Patient Perception of Bladder Condition [PPBC]
Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by general health related QoL
Time Frame: Baseline, Month 1, 3, 6 and 12
via the EuroQol 5D [EQ-5D]
Baseline, Month 1, 3, 6 and 12
Persistence with OAB drug treatment
Time Frame: Baseline till End of Study (ESV) (up to month 12)
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
Time Frame: Baseline till ESV (up to month 12)
As reported by patients and HCP
Baseline till ESV (up to month 12)
Switching of medication
Time Frame: Baseline till ESV (up to month 12)
As reported by patients and HCP
Baseline till ESV (up to month 12)
OAB drug treatment satisfaction
Time Frame: Baseline, month 1, 3, 6 and 12
Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)
Baseline, month 1, 3, 6 and 12
Reasons for switching of medication
Time Frame: Baseline till ESV (up to month 12)
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
Time Frame: Baseline till ESV (up to month 12)
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
Time Frame: Baseline till ESV (up to month 12)
As reported by patients and HCP for each specific medication, number and percent
Baseline till ESV (up to month 12)
Reasons for dose titration
Time Frame: Baseline till ESV (up to month 12)
As reported by patients and HCP for each specific medication
Baseline till ESV (up to month 12)
Frequency of dose titration
Time Frame: Baseline till ESV (up to month 12)
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
Time Frame: Baseline till ESV (up to month 12)
Adverse Events (AEs), Serious Adverse Events (SAEs)
Baseline till ESV (up to month 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Scientific & Medical Affairs, Inc.

Investigators

  • Study Director: Medical Director Urology, Astellas Scientific & Medical Affairs, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2015

Primary Completion (Actual)

August 4, 2017

Study Completion (Actual)

August 4, 2017

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 178-MA-1006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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