UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024442 |
|---|---|
| Receipt number | 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 11:57:53 |
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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
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
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of urology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028108
