UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of fesoterodine and mirabegron in the treatment of female overactive baldder patients with urgency incontinence: A randomized, prospective study (Feminine study)
Title of the study (Brief title)	Feminine study
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 female overactive baldder patients with urgency incontinence
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	the change of urgency incontinence between fesoterodine and mirabegron
Key secondary outcomes	the change of CLSS, OABSS, OAB-q, and ICIQ-SF

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
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 bladderor
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	total OAB symptom scores (OABSS) of >3, urgency incontinece episodes >1 per week, post-menopausal women, and age >50 years.
Key exclusion criteria	Patients were excluded if they received oral anticholinergic agents, alpha1-blockers, antidepressants, or anti-anxiety agents, had obvious neurogenic bladder dysfunction, bladder calculi, or active urinary tract infection, or had severe cardiac disease, renal dysfunction (serum-creatinine >2 mg/dL), and/or hepatic dysfunction (i.e., aspartate aminotransferase and alanine aminotransferase levels of more than twice the normal value)
Target sample size	300

Research contact person
Name of lead principal investigator	Yoshihisa Matsukawa
Organization	Nagoya University Graduate School of Medicine
Division name	department of urology
Address	65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL	052-744-2985
Email	yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yoshihisa Matsukawa
Organization	Nagoya University Graduate School of Medicine
Division name	Department of urology
Address	65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL	052-744-2985
Homepage URL
Email	yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute	Department of urology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of urology, Nagoya University Graduate 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)

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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 01 Month 31 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 02 Month 28 Day

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

Management information
Registered date	2016 Year 10 Month 17 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028108