UMIN-CTR Clinical Trial

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
Email	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
Email	ito218@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital Department of urology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052445