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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Overactive Bladder; Urinary Bladder Overactive; Urinary Bladder Diseases; Urologic Diseases

Intervention: mirabegron (Drug); antimuscarinic medication (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Astellas Scientific & Medical Affairs, Inc.

Official(s) and/or principal investigator(s):
Medical Director Urology, Study Director, Affiliation: Astellas Scientific & Medical Affairs, Inc.

Overall contact:
Astellas Scientific and Medical Affairs, Inc., Phone: 800-888-7704, Ext: 5473, Email: Astellas.registration@astellas.com


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)

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change from baseline in OAB-related QoL and symptom bother

Secondary outcome:

Effectiveness as measured by impression of severity of OAB

Effectiveness as measured by general health related QoL

Persistence with OAB drug treatment

Use of additional (add-on) medications

Switching of medication

OAB drug treatment satisfaction

Reasons for switching of medication

Reasons for discontinuation of medication

Reasons for add-on medication

Reasons for dose titration

Frequency of dose titration

Safety profile as assessed by recording AEs and SAEs


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Astellas Scientific and Medical Affairs, Inc., Phone: 800-888-7704, Ext: 5473, Email: Astellas.registration@astellas.com

1051 / Alabama Clinical Therapeutics, Birmingham, Alabama 35235, United States; Recruiting

1010 / Medical Affiliated Research Center, Inc. - ARC, Huntsville, Alabama 35801, United States; Recruiting

1020 / IMC - Diagnostic and Medical Clinic, Mobile, Alabama 36604, United States; Recruiting

1081 / Sunbelt Research Group, Mobile, Alabama 36607, United States; Recruiting

1026 / Vesia-Alberta Bladder Centre, Calgary, Alberta T2V 4R6, Canada; Recruiting

1006 / Arizona Urology, LLC, Goodyear, Arizona 85395, United States; Recruiting

1036 / Central Arizona Medical Associates, PC, Mesa, Arizona 85206, United States; Recruiting

1028 / Family Practice Specialists Ltd, Phoenix, Arizona 85018, United States; Recruiting

1073 / Arizona Research Associates, Tucson, Arizona 85712, United States; Recruiting

1083 / Urological Associates of Southern Arizona PC, Tucson, Arizona 85741, United States; Recruiting

1061 / Applied Research Center, Little Rock, Arkansas 72212, United States; Recruiting

1066 / Gain Medical Centre, Coquitlam, British Columbia V3K3P4, Canada; Recruiting

1000 / Silverado Research Inc., Victoria, British Columbia V8T2CL, Canada; Recruiting

1033 / Valley View Internal Medicine, Garden Grove, California 92845, United States; Recruiting

1011 / Havana Research Institute LLC, Pasadena, California 91105, United States; Recruiting

1013 / Aurora Care Clinic, Santa Ana, California 92701, United States; Recruiting

1050 / Direct Helpers Medical Center, Hialeah, Florida 33012, United States; Recruiting

1018 / Florida International Research Center, Miami, Florida 33173, United States; Recruiting

1031 / Sanitas Research, Miami, Florida 33155, United States; Recruiting

1032 / Bioclinical Research Alliance, Inc., Miami, Florida 33155, United States; Recruiting

1044 / My Community Research Center, Inc, Miami, Florida 33155, United States; Recruiting

1068 / San Marcus Research Clinic, Miami, Florida 33015, United States; Recruiting

1075 / Amun Medical Research, Miami, Florida 33185, United States; Recruiting

1079 / L and L Research Choices, Miami, Florida 33144, United States; Recruiting

1048 / Med-Care Research, North Miami Beach, Florida 33162, United States; Recruiting

1055 / Urology Center of Florida, Pompano Beach, Florida 33060, United States; Recruiting

1042 / Sonar Groups, LLC, Atlanta, Georgia 30342, United States; Recruiting

1035 / Geriatrics & Family Medicine Center of Columbus, Columbus, Georgia 31909, United States; Recruiting

1009 / Urban Family Practice Associates, Marietta, Georgia 30067, United States; Recruiting

1069 / Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia 30328, United States; Recruiting

1016 / Leavitt Women's Healthcare, Idaho Falls, Idaho 83404, United States; Recruiting

1046 / Comprehensive Urologic Care, SC, Lake Barrington, Illinois 60010, United States; Recruiting

1019 / Clinical Research Advantage, Inc., Evansville, Indiana 47714, United States; Recruiting

1034 / Family Medical Associates, Evansville, Indiana 47725, United States; Recruiting

1017 / Ridge Family Practice, PC, Council Bluffs, Iowa 51503, United States; Recruiting

1064 / College Park Family Care Center, Overland Park, Kansas 66210, United States; Recruiting

1077 / Lafayette General Health, Lafayette, Louisiana 70503, United States; Recruiting

1058 / Anne Arundel Urology, Annapolis, Maryland 21401, United States; Recruiting

1059 / Genesis Clinical Research, Fall River, Massachusetts 02720, United States; Recruiting

1076 / Bay State Clinical Trials Inc, Watertown, Massachusetts 02472, United States; Recruiting

1062 / Health First Medical Center, Hamtramck, Michigan 48212, United States; Recruiting

1074 / Oakland Medical Research Center, Troy, Michigan 48085, United States; Recruiting

1047 / HealthCare Research Network, Hazelwood, Missouri 63042, United States; Recruiting

1082 / CenterPointe Institute of Research, St. Louis, Missouri 63128, United States; Recruiting

1039 / Southwest Family Physicians, PC, Omaha, Nebraska 68124, United States; Recruiting

1043 / Clifford J. Molin, MD, LTD/Clinical Research Advantage, Inc., Las Vegas, Nevada 89128, United States; Recruiting

1052 / CIMA Medical Research, Inc, Las Vegas, Nevada 89146, United States; Recruiting

1001 / Maynard Holgado, LLC, Sicklerville, New Jersey 08081, United States; Recruiting

1008 / New Mexico Clinical Research & Osteo Center, Albuquerque, New Mexico 87106, United States; Recruiting

1040 / Premier Medical Group, Newburgh, New York 12550, United States; Recruiting

1045 / Premier Medical Group of the Hudson Valley, PC, Poughkeepsie, New York 12601, United States; Recruiting

1056 / Wake Research Associates, Raleigh, North Carolina 27612, United States; Recruiting

1060 / Family Medical Associates of Raleigh, Raleigh, North Carolina 27609, United States; Recruiting

1049 / Agarwal Nephrology & Hypertension PC and Agarwal Family Care, Columbus, Ohio 31901, United States; Recruiting

1007 / Buckeye Health & Research, Hilliard, Ohio 43026, United States; Recruiting

1022 / G. Kenneth Jansz Medical Professional Corporation, Burlington, Ontario L7NV3V2, Canada; Recruiting

1029 / Joseph Brant Memorial Hospital, Burlington, Ontario L7S 1W7, Canada; Recruiting

1072 / Centre for Applied Urological Research, Kingston, Ontario K7L357, Canada; Recruiting

1023 / Robert G. Luton, MD, London, Ontario N6A566, Canada; Recruiting

1014 / Malton Medical Center, Mississauga, Ontario L4T 4J2, Canada; Recruiting

1025 / King Street Medical Clinic, Oshawa, Ontario L1H1G6, Canada; Recruiting

1065 / The Ottawa Hospital, Ottawa, Ontario K1Y4E9, Canada; Recruiting

1054 / Adam Clinical Trials LTD, Scarborough, Ontario M1R3A6, Canada; Recruiting

1005 / Dr Tara Moskalyk, Sudbury, Ontario P3E 379, Canada; Recruiting

1027 / Dr. Barbara Erdelyi Private Practice, Toronto, Ontario M2J2K9, Canada; Recruiting

1021 / Brandywine Clinical Research, Downington, Pennsylvania 19335, United States; Recruiting

1078 / Jeffrey A. Lindenbaum, Yardley, Pennsylvania 19067, United States; Recruiting

1038 / UltraMed Inc., Pointe-Claire, Quebec H9R4S3, Canada; Recruiting

1053 / Center for Medical Research, LLC, Providence, Rhode Island 02907, United States; Recruiting

1070 / Greater Providence Clinical Research, Providence, Rhode Island 02914, United States; Recruiting

1004 / Family Medicine of SayeBrook, Myrtle Beach, South Carolina 29588, United States; Recruiting

1084 / Sanford RSCH, Sioux Falls, South Dakota 57104, United States; Recruiting

1015 / Alpha Clinical Research, LLC, Clarksville, Tennessee 37040, United States; Recruiting

1037 / Oakmont Wellness Center, PA, Fort Worth, Texas 76132, United States; Recruiting

1067 / Joseph A. Montes, MD, Houston, Texas 77055, United States; Recruiting

1080 / Biopharma Informatic Research Center, Houston, Texas 77043, United States; Recruiting

1057 / Severino Pimentel, Katy, Texas 77450, United States; Recruiting

1012 / Doctors of Internal Medicine, Plano, Texas 75093, United States; Recruiting

1071 / Monroe Clinic, Monroe, Wisconsin 53566, United States; Recruiting

Additional Information

Starting date: January 2015
Last updated: July 1, 2015

Page last updated: August 23, 2015

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