Urinary Bladder OveractivePERSPECTIVENCT02386072
A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
An observational study of Urinary Bladder Overactive and Overactive Bladder, run by Astellas Scientific & Medical Affairs, Inc. at 92 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases
- What is being tested?
- mirabegron and antimuscarinic medication
- Type of treatment
- Pill or oral medicine
- How many people
- 1,524 participants
- Where
- 92 sitesin 2 countries
- Study dates
- 5 Jan 2015to 4 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
92 sites in 2 countries.
92 sites in 2 countries
United States75 sites
Site US1008
Albuquerque, New Mexico, 87106
Site US1058
Annapolis, Maryland, 21401
Site US1042
Atlanta, Georgia, 30342
Site US1051
Birmingham, Alabama, 35235
Site US1094
Birmingham, Alabama, 35242
Site US1103
Buffalo, New York, 14203
Site US1088
Burlington, Massachusetts, 01805
Site US1015
Clarksville, Tennessee, 37040
Site US1035
Columbus, Georgia, 31909
Site US1017
Council Bluffs, Iowa, 51503
Site US1021
Downingtown, Pennsylvania, 19335
Site US1019
Evansville, Indiana, 47714
Site US1034
Evansville, Indiana, 47725
Site US1059
Fall River, Massachusetts, 02720
Site US1037
Fort Worth, Texas, 76132
Site US1096
Garden City, New York, 11530
Site US1112
Garden Grove, California, 92844
Site US1006
Goodyear, Arizona, 85395
Site US1062
Hamtramck, Michigan, 48212
Site US1047
Hazelwood, Missouri, 63042
Site US1050
Hialeah, Florida, 33012
Site US1007
Hilliard, Ohio, 43026
Site US1080
Houston, Texas, 77043
Site US1067
Houston, Texas, 77055
Site US1010
Huntsville, Alabama, 35801
Site US1016
Idaho Falls, Idaho, 83404
Site US1057
Katy, Texas, 77450
Site US1077
Lafayette, Louisiana, 70503
Site US1046
Lake Barrington, Illinois, 60010
Site US1043
Las Vegas, Nevada, 89128
Site US1052
Las Vegas, Nevada, 89146
Site US1114
Little Rock, Arkansas, 72205
Site US1061
Little Rock, Arkansas, 72212
Site US1009
Marietta, Georgia, 30067
Site US1036
Mesa, Arizona, 85206
Site US1068
Miami, Florida, 33015
Site US1079
Miami, Florida, 33144
Site US1031
Miami, Florida, 33155
Site US1032
Miami, Florida, 33155
Site US1044
Miami, Florida, 33155
Site US1018
Miami, Florida, 33173
Site US1098
Miami, Florida, 33175
Site US1075
Miami, Florida, 33185
Site US1020
Mobile, Alabama, 36604
Site US1071
Monroe, Wisconsin, 53566
Site US1097
Muncie, Indiana, 47304
Site US1004
Myrtle Beach, South Carolina, 29588
Site US1085
New Brunswick, New Jersey, 08901
Site US1106
New York, New York, 10003
Site US1111
New York, New York, 10065
Site US1040
Newburgh, New York, 12550
Site US1048
North Miami Beach, Florida, 33162
Site US1090
Northglenn, Colorado, 80234
Site US1093
Ocoee, Florida, 34761
Site US1102
Omaha, Nebraska, 68114
Site US1039
Omaha, Nebraska, 68124
Site US1064
Overland Park, Kansas, 66210
Site US1028
Phoenix, Arizona, 85018
Site US1012
Plano, Texas, 75093
Site US1055
Pompano Beach, Florida, 33060
Site US1045
Poughkeepsie, New York, 12601
Site US1070
Providence, Rhode Island, 02914
Site US1060
Raleigh, North Carolina, 27609
Site US1104
Sacramento, California, 95817
Site US1013
Santa Ana, California, 92701
Site US1086
Seattle, Washington, 98104
Site US1001
Sicklerville, New Jersey, 08081
Site US1084
Sioux Falls, South Dakota, 57104
Site US1082
St Louis, Missouri, 63128
Site US1105
St Louis, Missouri, 63141
Site US1100
Tucson, Arizona, 85715
Site US1083
Tucson, Arizona, 85741
Site US1099
Virginia Beach, Virginia, 23462
Site US1076
Watertown, Massachusetts, 02472
Site US1089
Worcester, Massachusetts, 01605
Canada17 sites
Site CA1022
Burlington, Ontario, L7NV3V2
Site CA1029
Burlington, Ontario, L7S 1W7
Site CA1026
Calgary, Alberta, T2V 4R6
Site CA1066
Coquitlam, British Columbia, V3K3P4
Site CA1005
Greater Sudbury, Ontario, P3E 379
Site CA1072
Kingston, Ontario, K7L357
Site CA1023
London, Ontario, N6A566
Site CA1014
Mississauga, Ontario, L4T 4J2
Site CA1095
Oshawa, Ontario, L1H 1G4
Site CA1025
Oshawa, Ontario, L1H1G6
Site CA1065
Ottawa, Ontario, K1Y4E9
Site CA1038
Pointe-Claire, Quebec, H9R4S3
Site CA1101
Richmond Hill, Ontario, L4C 1T9
Site CA1054
Scarborough Village, Ontario, M1R3A6
Site CA1027
Toronto, Ontario, M2J2K9
Site CA1092
Toronto, Ontario, M5T2S8
Site CA1000
Victoria, British Columbia, V8T2CL
About this study
Official title: 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)
- Conditions
- Urinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases, Urologic Diseases
- Being tested
- mirabegron, antimuscarinic medication
- Keywords
- Betanis®, Myrbetriq®, Quality of Life, Antimuscarinics, Betmiga®, Overactive Bladder, Observational
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirabegronDrug
Also called YM178, Betanis, Myrbetriq, Betmiga
oral
antimuscarinic medicationDrug
Also called Ditropan XL, Gelnique, Enablex, Trosec
oral
| Study group | Role | What they receive |
|---|---|---|
| 1. patients diagnosed with OAB taking mirabegron | patients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice Receives: Drug: mirabegron | |
| 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 Receives: Drug: antimuscarinic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 1, 3, 6 and 12
Secondary outcomes (12)
Effectiveness as measured by impression of severity of OAB
Via the Patient Perception of Bladder Condition [PPBC]
Measured: Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by general health related QoL
via the EuroQol 5D [EQ-5D]
Measured: Baseline, Month 1, 3, 6 and 12
Persistence with OAB drug treatment
The duration of time a patient continues to take the prescribed medication
Measured: Baseline till End of Study (ESV) (up to month 12)
Use of additional (add-on) medications
As reported by patients and HCP
Measured: Baseline till ESV (up to month 12)
Switching of medication
As reported by patients and HCP
Measured: Baseline till ESV (up to month 12)
OAB drug treatment satisfaction
Via the Overactive Bladder Treatment Satisfaction Questionnaire (OAB-S)
Measured: Baseline, month 1, 3, 6 and 12
Reasons for switching of medication
As reported by patients and HCP for each specific medication, number and percent
Measured: Baseline till ESV (up to month 12)
Reasons for discontinuation of medication
As reported by patients and HCP for each specific medication, number and percent
Measured: Baseline till ESV (up to month 12)
Reasons for add-on medication
As reported by patients and HCP for each specific medication, number and percent
Measured: Baseline till ESV (up to month 12)
Reasons for dose titration
As reported by patients and HCP for each specific medication
Measured: Baseline till ESV (up to month 12)
Frequency of dose titration
As reported by patients and HCP for each specific medication
Measured: Baseline till ESV (up to month 12)
Safety profile as assessed by recording AEs and SAEs
Adverse Events (AEs), Serious Adverse Events (SAEs)
Measured: Baseline till ESV (up to month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study start5 Jan 2015
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Scientific & Medical Affairs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Urology, Study director, Astellas Scientific & Medical Affairs, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386072
- Sponsor's protocol ID
- 178-MA-1006
- Acronym
- PERSPECTIVE
- Status last verified
- Oct 2018
- First submitted
- 6 Mar 2015
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Publications
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.
PubMed 31222714Rovner 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.
PubMed 29777865
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Registry Study of Patients Initiating a Course of DrugTherapy for Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT02386072
- Acronym / sponsor ID
- PERSPECTIVE / 178-MA-1006
- Conditions
- Urinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases, Urologic Diseases
- Keywords
- Betanis®, Myrbetriq®, Quality of Life, Antimuscarinics, Betmiga®, Overactive Bladder, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,524 participants (actual)
- Lead sponsor
- Astellas Scientific & Medical Affairs, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. patients diagnosed with OAB taking mirabegron | – | Drug: mirabegronpatients diagnosed with OAB whose physician has decided to prescribe mirabegron as part of routine clinical practice |
| 2. patients diagnosed with OAB taking an antimuscarinic | – | Drug: antimuscarinic medicationpatients diagnosed with OAB whose physician has decided to prescribe an antimuscarinic as part of routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mirabegronAlso: YM178, Betanis, Myrbetriq, Betmigaoral | Drug | 1. patients diagnosed with OAB taking mirabegron |
| antimuscarinic medicationAlso: Ditropan XL, Gelnique, Enablex, Trosecoral | Drug | 2. patients diagnosed with OAB taking an antimuscarinic |
Primary outcome
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
12 secondary outcomes
Effectiveness as measured by impression of severity of OAB
Time frame: Baseline, Month 1, 3, 6 and 12
Effectiveness as measured by general health related QoL
Time frame: Baseline, Month 1, 3, 6 and 12
Persistence with OAB drug treatment
Time frame: 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)
Switching of medication
Time frame: Baseline till ESV (up to month 12)
OAB drug treatment satisfaction
Time frame: Baseline, month 1, 3, 6 and 12
Reasons for switching of medication
Time frame: Baseline till ESV (up to month 12)
Reasons for discontinuation of medication
Time frame: Baseline till ESV (up to month 12)
Reasons for add-on medication
Time frame: Baseline till ESV (up to month 12)
Reasons for dose titration
Time frame: Baseline till ESV (up to month 12)
Frequency of dose titration
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 31222714Carlson 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.
- Derived from this study: PubMed 29777865Rovner 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.
- Individual participant dataSharing planned: No. 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/.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Urology study director
Astellas Scientific & Medical Affairs, Inc.
92 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Overactive and Overactive Bladder, run by Astellas Scientific & Medical Affairs, Inc. at 92 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in OAB-related QoL and symptom bother (time frame: Baseline, Month 1, 3, 6 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386072, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.