UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Personalized medication for overactive bladder with imidafenacin treatment
Title of the study (Brief title)	PERMIT study
Region	Japan

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

Objectives
Narrative objectives1	The comparison of impact on the quality of life between personalized and controlled dosage of medicine for overactive bladder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	King's Health Questionnaire
Key secondary outcomes	Overactive bladder symptom score (OABSS) IPSS-QOL score adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	[Personalized medication] First 2 weeks: imidafenacin 0.1mg x 2/day (Fixed) Following 3-12 weeks: imidafenacin 0.1-0.4mg/day depending on the subjective decision of the patients
Interventions/Control_2	[Controlled medication] First 2 weeks: imidafenacin 0.1mg x 2/day (Fixed) Following 3-12 weeks: imidafenacin 0.2-0.4mg/day depending on the objective decision of the doctors
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	Female
Key inclusion criteria	OABSS: urgency score 3 and more, and total score 6 and more
Key exclusion criteria	- Urinary retention within the last 12 months - Post-void residual urine 100mL and more - Indwelling catheter or Intermittent catheterization - Sleep apnea syndrome, Restless legs syndrome or insomnia - acute urinary infection
Target sample size	100

Research contact person
Name of lead principal investigator	Kazumasa Torimoto
Organization	Nara Medical University
Division name	Urology
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	torimoto@naramed-u.ac.jp

Public contact
Name of contact person	Kazumasa Torimoto
Organization	Nara Medical University
Division name	Urology
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	torimoto@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	Nara Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 03 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 03 Month 01 Day
Anticipated trial start date	2017 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 01 Month 24 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029691