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

NCT ID: NCT02386072

Last Updated: 2024-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1524 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-05

Study Completion Date

2017-08-04

Brief Summary

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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

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Conditions

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Urinary Bladder Overactive Overactive Bladder Urinary Bladder Diseases Urologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1. patients diagnosed with OAB taking mirabegron

patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice

mirabegron

Intervention Type DRUG

oral

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

antimuscarinic medication

Intervention Type DRUG

oral

Interventions

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mirabegron

oral

Intervention Type DRUG

antimuscarinic medication

oral

Intervention Type DRUG

Other Intervention Names

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YM178 Betanis Myrbetriq Betmiga Ditropan XL Gelnique Enablex Trosec Sanctura Oxybutynin IR Vesicare Oxytrol Toviaz Detrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Scientific & Medical Affairs, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Urology

Role: STUDY_DIRECTOR

Astellas Scientific & Medical Affairs, Inc.

Locations

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Site US1051

Birmingham, Alabama, United States

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Site US1094

Birmingham, Alabama, United States

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Site US1010

Huntsville, Alabama, United States

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Site US1020

Mobile, Alabama, United States

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Site US1006

Goodyear, Arizona, United States

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Site US1036

Mesa, Arizona, United States

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Site US1028

Phoenix, Arizona, United States

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Site US1100

Tucson, Arizona, United States

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Site US1083

Tucson, Arizona, United States

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Site US1114

Little Rock, Arkansas, United States

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Site US1061

Little Rock, Arkansas, United States

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Site US1112

Garden Grove, California, United States

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Site US1104

Sacramento, California, United States

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Site US1013

Santa Ana, California, United States

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Site US1090

Northglenn, Colorado, United States

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Site US1050

Hialeah, Florida, United States

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Site US1068

Miami, Florida, United States

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Site US1079

Miami, Florida, United States

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Site US1031

Miami, Florida, United States

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Site US1032

Miami, Florida, United States

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Site US1044

Miami, Florida, United States

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Site US1018

Miami, Florida, United States

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Site US1098

Miami, Florida, United States

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Site US1075

Miami, Florida, United States

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Site US1048

North Miami Beach, Florida, United States

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Site US1093

Ocoee, Florida, United States

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Site US1055

Pompano Beach, Florida, United States

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Site US1042

Atlanta, Georgia, United States

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Site US1035

Columbus, Georgia, United States

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Site US1009

Marietta, Georgia, United States

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Site US1016

Idaho Falls, Idaho, United States

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Site US1046

Lake Barrington, Illinois, United States

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Site US1019

Evansville, Indiana, United States

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Site US1034

Evansville, Indiana, United States

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Site US1097

Muncie, Indiana, United States

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Site US1017

Council Bluffs, Iowa, United States

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Site US1064

Overland Park, Kansas, United States

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Site US1077

Lafayette, Louisiana, United States

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Site US1058

Annapolis, Maryland, United States

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Site US1088

Burlington, Massachusetts, United States

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Site US1059

Fall River, Massachusetts, United States

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Site US1076

Watertown, Massachusetts, United States

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Site US1089

Worcester, Massachusetts, United States

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Site US1062

Hamtramck, Michigan, United States

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Site US1047

Hazelwood, Missouri, United States

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Site US1082

St Louis, Missouri, United States

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Site US1105

St Louis, Missouri, United States

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Site US1102

Omaha, Nebraska, United States

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Site US1039

Omaha, Nebraska, United States

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Site US1043

Las Vegas, Nevada, United States

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Site US1052

Las Vegas, Nevada, United States

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Site US1085

New Brunswick, New Jersey, United States

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Site US1001

Sicklerville, New Jersey, United States

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Site US1008

Albuquerque, New Mexico, United States

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Site US1103

Buffalo, New York, United States

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Site US1096

Garden City, New York, United States

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Site US1106

New York, New York, United States

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Site US1111

New York, New York, United States

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Site US1040

Newburgh, New York, United States

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Site US1045

Poughkeepsie, New York, United States

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Site US1060

Raleigh, North Carolina, United States

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Site US1007

Hilliard, Ohio, United States

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Site US1021

Downingtown, Pennsylvania, United States

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Site US1070

Providence, Rhode Island, United States

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Site US1004

Myrtle Beach, South Carolina, United States

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Site US1084

Sioux Falls, South Dakota, United States

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Site US1015

Clarksville, Tennessee, United States

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Site US1037

Fort Worth, Texas, United States

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Site US1080

Houston, Texas, United States

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Site US1067

Houston, Texas, United States

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Site US1057

Katy, Texas, United States

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Site US1012

Plano, Texas, United States

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Site US1099

Virginia Beach, Virginia, United States

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Site US1086

Seattle, Washington, United States

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Site US1071

Monroe, Wisconsin, United States

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Site CA1026

Calgary, Alberta, Canada

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Site CA1066

Coquitlam, British Columbia, Canada

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Site CA1000

Victoria, British Columbia, Canada

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Site CA1022

Burlington, Ontario, Canada

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Site CA1029

Burlington, Ontario, Canada

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Site CA1005

Greater Sudbury, Ontario, Canada

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Site CA1072

Kingston, Ontario, Canada

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Site CA1023

London, Ontario, Canada

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Site CA1014

Mississauga, Ontario, Canada

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Site CA1095

Oshawa, Ontario, Canada

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Site CA1025

Oshawa, Ontario, Canada

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Site CA1065

Ottawa, Ontario, Canada

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Site CA1101

Richmond Hill, Ontario, Canada

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Site CA1054

Scarborough Village, Ontario, Canada

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Site CA1027

Toronto, Ontario, Canada

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Site CA1092

Toronto, Ontario, Canada

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Site CA1038

Pointe-Claire, Quebec, Canada

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Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 31222714 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29777865 (View on PubMed)

Other Identifiers

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178-MA-1006

Identifier Type: -

Identifier Source: org_study_id

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