UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038636
Receipt number R000044026
Scientific Title Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB)
Date of disclosure of the study information 2019/12/01
Last modified on 2019/11/19 16:47:20

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Basic information

Public title

Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB)

Acronym

OAB beta3 agonists sequential therapy

Scientific Title

Clinical outcome of beta3 agonists, Mirabegron and Vibegron sequential therapy for overactive bladder(OAB)

Scientific Title:Acronym

OAB beta3 agonists sequential therapy

Region

Japan


Condition

Condition

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Evaluation of beta3 agonists sequential therapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change of OABSS after 8 week initial beta3 agonist therapy and change of OABSS after 8 week beta3 agonist sequential therapy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


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

Initially treated with Mirabegron for 2months and switched to Vibegron for 2months

Interventions/Control_2

Initially treated with Vibegron for 2months and switched to Mirabegron for 2months

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who fit the following criteria

1) chief complaint is urinary urgency
2) OABSS total score is more than 3 and Q3 is more than 2
3) accepted with written consent

Key exclusion criteria

1) Urgency due to bladder infection,urinary malignancies
2) patients who is not available for beta3 agonist treatment
3) deny attending this clinical research

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shunsuke
Middle name
Last name Tsuzuki

Organization

Jikei University school of medicine

Division name

Department of Urology

Zip code

105-8461

Address

3-25-8 Nishishinbashi Minato-ku Tokyo Japan

TEL

03-3433-1111

Email

tsuzushun60@gmail.com


Public contact

Name of contact person

1st name Shunsuke
Middle name
Last name Tsuzuki

Organization

Jikei University school of medicine

Division name

Department of Urology

Zip code

105-8461

Address

3-25-8 Nishishinbashi Minato-ku Tokyo Japan

TEL

03-3433-1111

Homepage URL


Email

tsuzushun60@gmail.com


Sponsor or person

Institute

Jikei University school of medicine

Institute

Department

Personal name



Funding Source

Organization

Jikei University school of medicine

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

The ethic committee office, Jikei University school of medicine

Address

3-25-8 Nishishinbashi Minato-ku Tokyo Japan

Tel

03-3433-1111

Email

jikei@esct.bvits.com


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

2019 Year 12 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

2019 Year 11 Month 11 Day

Date of IRB


Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2021 Year 10 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

2019 Year 11 Month 19 Day

Last modified on

2019 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044026


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name