UMIN-CTR Clinical Trial

Basic information
Public title	The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent
Acronym	The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent
Scientific Title	The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent
Scientific Title:Acronym	The examination of the efficacy by adverse reaction changing the treatment with Oxybutynin or Mirabegron on the patient who cannot go on treatment with anticholinergic agent
Region	Japan

Condition
Condition	Overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the efficacy of the changing medicine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	satisfaction of the patient
Key secondary outcomes	IPSS,OABSS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are 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	using oxybutynin for 12 weeks
Interventions/Control_2	usin mirabegron for 12 weeks
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	want to change the midicine by adverse reaction
Key exclusion criteria	contraindication of the medicine acute urinary retension within 12 months residual urine over 100mL urinary infection a1 blacker within 4 weeks
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Kawauchi
Organization	Shiga Uneversity of medical science
Division name	Urology
Zip code	5202192
Address	Setatsukinowacho Otsu Shiga
TEL	0775482273
Email	tsuru-sig@umin.ac.jp

Public contact
Name of contact person	1st name Teruhiko Middle name Last name Tsuru
Organization	Shiga University of medical Science
Division name	Urology
Zip code	5202192
Address	Setatsukinowacho Otsu Shiga
TEL	0775482273
Homepage URL
Email	tsuru@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Urology, Shiga University of medical science
Institute
Department

Funding Source
Organization	Self funding
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	Shiga University of medical science
Address	Setatsukinowacho Otsu Shiga
Tel	077-548-2273
Email	tsuru-sig@umin.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	2015 Year 11 Month 10 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	15
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	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 22 Day
Date of IRB	2015 Year 11 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2025 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	2015 Year 11 Month 10 Day
Last modified on	2020 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022671