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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040425
Receipt No. R000046131
Scientific Title Effects of fesoterodine on frequency/volume chart in treatment-naive female patients with overactive bladder in the real-world clinical setting
Date of disclosure of the study information 2020/05/20
Last modified on 2020/05/17

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Basic information
Public title Effects of fesoterodine on frequency/volume chart in treatment-naive female patients with overactive bladder in the real-world clinical setting
Acronym Effects of fesoterodine on frequency/volume chart
Scientific Title Effects of fesoterodine on frequency/volume chart in treatment-naive female patients with overactive bladder in the real-world clinical setting
Scientific Title:Acronym Effects of fesoterodine on frequency/volume chart
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effects of fesoterodine on frequency/volume chart in patients with overactive bladder
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of the number of voids
Key secondary outcomes change of mean voided volume

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Treatment-naive Japanese female patients who visited the hospital for the symptoms of OAB and were clinically diagnosed with OAB
Key exclusion criteria Patients with urinary tract infection, large postvoid residual volume, a previous treatment history for OAB, and contraindications to use of fesoterodine
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code 043-002
Address 484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
TEL 0139-52-0036
Email rinoshiyokanata@me.com

Public contact
Name of contact person
1st name Yoshinori
Middle name
Last name Tanaka
Organization Hokkaido Prefectural Esashi Hospital
Division name Division of Urology
Zip code 043-0022
Address 484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
TEL 0139-52-0036
Homepage URL
Email rinoshiyokanata@me.com

Sponsor
Institute Hokkaido Prefectural Esashi Hospital
Institute
Department

Funding Source
Organization None
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 Ethics Committee of Hokkaido Prefectural Esashi Hospital
Address 484, Fushikido-cho, Esashi-cho, Hiyama-gun, Hokkaido 043-0022, Japan
Tel 0139-52-0036
Email hofuku.esabyo2@pref.hokkaido.jg.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
2020 Year 05 Month 20 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 100
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 09 Month 26 Day
Date of IRB
2014 Year 09 Month 26 Day
Anticipated trial start date
2014 Year 10 Month 01 Day
Last follow-up date
2020 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2020 Year 05 Month 17 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046131

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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