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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024442
Receipt No. R000028108
Scientific Title Comparison of fesoterodine and mirabegron in the treatment of female overactive baldder patients with urgency incontinence: A randomized, prospective study (Feminine study)
Date of disclosure of the study information 2016/11/01
Last modified on 2017/01/21

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Basic information
Public title Comparison of fesoterodine and mirabegron in the treatment of female overactive baldder patients with urgency incontinence: A randomized, prospective study (Feminine study)
Acronym Feminine study
Scientific Title Comparison of fesoterodine and mirabegron in the treatment of female overactive baldder patients with urgency incontinence: A randomized, prospective study (Feminine study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name department of urology
Zip code
Address 65 tsurumai, Showa-ku, Nagoya, JAPAN
TEL 052-744-2985
Email yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Department of urology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
Date of protocol fixation
2016 Year 12 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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