UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045947 |
|---|---|
| Receipt number | R000052445 |
| Scientific Title | Prospective comparison of mirabegron and fesoterodine for overactive bladder |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/11/01 14:35:42 |
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Basic information
Public title
Prospective comparison of mirabegron and fesoterodine for overactive bladder
Acronym
Prospective comparison of mirabegron and fesoterodine for overactive bladder
Scientific Title
Prospective comparison of mirabegron and fesoterodine for overactive bladder
Scientific Title:Acronym
Prospective comparison of mirabegron and fesoterodine for overactive bladder
Region
| Japan |
Condition
Condition
Overactive bladder(OAB)
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the use of mirabegron and fesoterodine by comparison the efficacy of both in patients with overactive bladder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Improvement of 3 points or more in total OABSS(OAB symptom scores) after 12 weeks' treatment
Key secondary outcomes
Less than 1 point in OABSS-Q3 or less than 2 ponits in total OABSS score after 12 weeks' treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of Mirabegron 50mg
Interventions/Control_2
The administration of fesoterodine 4mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)More than 3 points in total OABSS and more than 2 points in OABSS-Q3(urinary urgency episodes more than 1 per week)
2)Untreated Patients of overactive bladder.
3)Patients more than 20 years old.
4)Regardless of gender.
5)Ability and willingness to provide written informed consent and comply with the requirements of the study protocol
Key exclusion criteria
Patients were excluded if they received treatment with anticholinergic agents,beta3-adrenoceptor agonist,BOTOX injection,propafenone hydrochloride or flecainide acetate; if they had hypersensitivity to mirabegron,fesoterodine or tolterodine; if they had renal dysfunction,hepatic dysfunction,severe cardiac disease,urinary retention,closed-angle glaucoma,ileus,atony or myasthenia gravis; if they are not able to answer questionnaires and they need proxies; if they are pregnant or want to have a baby in the future; and if they pacitipated other clinical research.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yasuyoshi |
| Middle name | |
| Last name | Miyata |
Organization
Nagasaki University Hospital
Division name
Department of urology
Zip code
8528501
Address
1-7-1 Sakamoto,Nagasaki City,Naagasaki Prefecture,Japan
TEL
0958197340
yasu-myt@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Ito |
Organization
Nagasaki University Hospital
Division name
Department of urology
Zip code
8528501
Address
1-7-1 Sakamoto,Nagasaki City,Naagasaki Prefecture,Japan
TEL
0958197340
Homepage URL
ito218@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Department of urology
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital
Address
1-7-1 Sakamoto,Nagasaki City,Naagasaki Prefecture,Japan
Tel
0958197340
ito218@nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052445
