UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038196
Receipt number R000043536
Scientific Title A randomized controlled trial of mirabegran and fesoterodine in overactive bladder
Date of disclosure of the study information 2020/03/01
Last modified on 2019/10/03 17:57:18

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Basic information

Public title

A randomized controlled trial of mirabegran and fesoterodine in overactive bladder

Acronym

A randomized controlled trial of mirabegran and fesoterodine in overactive bladder

Scientific Title

A randomized controlled trial of mirabegran and fesoterodine in overactive bladder

Scientific Title:Acronym

A randomized controlled trial of mirabegran and fesoterodine in overactive bladder

Region

Japan


Condition

Condition

overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to compare the efficacy of fesoterodine and mirabegron in the treatment of overactive bladder patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

total score of overactive bladder symptom score

Key secondary outcomes

each score of overactive bladder symptom score, total score of overactive bladder symptom score international prostate symptom score, total score of King's Health Questionnaire, frequency volume chart, urofluometry, residual urine


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

the intervention of fesoterodine as the treatment of overactive bladder

Interventions/Control_2

the intervention of mirabegron as the treatment of overactive bladder

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

total score of overactive bladder symptom score >3, score of question 3 in overactive bladder symptom score >2

Key exclusion criteria

patients with a history of hypersensitivity to fesoterodine or mirabegron

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Tomohiko
Middle name
Last name Kamasako

Organization

Dokkyo Medical University Hospital

Division name

Department of Urology, Continence Center

Zip code

321-0293

Address

880, Kitakobayashi, Mibu, Tochigi

TEL

0282861111

Email

kamasako@dokkyomed.ac.jp


Public contact

Name of contact person

1st name Tomohiko
Middle name
Last name Kamasako

Organization

Dokkyo Medical University Hospital

Division name

Department of Urology, Continence Center

Zip code

321-0293

Address

880, Kitakobayashi, Mibu, Tochigi

TEL

0282861111

Homepage URL


Email

kamasako@dokkyomed.ac.jp


Sponsor or person

Institute

Dokkyo Medical University

Institute

Department

Personal name



Funding Source

Organization

Dokkyo Medical University

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

Dokkyo Medical University Hospital

Address

880, Kitakobayashi, Mibu, Tochigi

Tel

0282861111

Email

kamasako@dokkyomed.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

2020 Year 03 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

2020 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 10 Month 03 Day

Last modified on

2019 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043536


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name