UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029048
Receipt number R000033212
Scientific Title Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting
Date of disclosure of the study information 2017/09/09
Last modified on 2019/10/19 21:49:00

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Basic information

Public title

Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting

Acronym

Reasons for withdrawal from mirabegron for OAB

Scientific Title

Investigation of the reasons for withdrawal from long-term treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder in the real-world clinical setting

Scientific Title:Acronym

Reasons for withdrawal from mirabegron for OAB

Region

Japan


Condition

Condition

Overactive bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The persistence of treatment with mirabegron and the reasons for withdrawal from the treatment among treatment-naive Japanese female patients with overactive bladder were prospectively investigated for 3 years in the real-world clinical setting

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The reasons for withdrawal from the treatment with mirabegron of treatment-naive Japanese female patients with overactive bladder

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Post-menopausal treatment-naive Japanese female patients who visited the hospital for the symptoms of OAB and were clinically diagnosed with OAB

Key exclusion criteria

Patients with premenopausal, urinary tract infection, large postvoid residual volume (more than 150 mL), a previous treatment history for OAB, and contraindications to use of mirabegron

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Yoshinori
Middle name
Last name Tanaka

Organization

Hokkaido Prefectural Esashi Hospital

Division name

Division of Urology

Zip code

043-0022

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan

TEL

0139-52-0036

Email

rinoshiyokanata@me.com


Public contact

Name of contact person

1st name Yoshinori
Middle name
Last name Tanaka

Organization

Hokkaido Prefectural Esashi Hospital

Division name

Division of Urology

Zip code

043-0022

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan

TEL

0139-52-0036

Homepage URL


Email

rinoshiyokanata@me.com


Sponsor or person

Institute

Hokkaido Prefectural Esashi Hospital

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

Ethics Committee of Hokkaido Prefectural Esashi Hospital

Address

484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido, Japan

Tel

0139-52-0036

Email

hofuku.esabyo2@pref.hokkaido.jg.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

2017 Year 09 Month 09 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2011 Year 09 Month 23 Day

Date of IRB

2011 Year 09 Month 23 Day

Anticipated trial start date

2011 Year 10 Month 03 Day

Last follow-up date

2017 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients visited the hospital between October 2011 and July 2014


Management information

Registered date

2017 Year 09 Month 07 Day

Last modified on

2019 Year 10 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033212


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name