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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026619
Receipt No. R000030573
Scientific Title Assessment of urethral function after radical prostatectomy using ultrasonography
Date of disclosure of the study information 2017/03/27
Last modified on 2018/09/25

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Basic information
Public title Assessment of urethral function after radical prostatectomy using ultrasonography
Acronym Assessment of urethral function using ultrasonography
Scientific Title Assessment of urethral function after radical prostatectomy using ultrasonography
Scientific Title:Acronym Assessment of urethral function using ultrasonography
Region
Japan

Condition
Condition urinary incontinence after radical prostatectomy
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Assessment for mechanisms of urinary incontinence after radical prostatectomy
Basic objectives2 Others
Basic objectives -Others morphological change after surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes findings of ultrasonography
Key secondary outcomes

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
50 years-old <=
Age-upper limit
75 years-old >=
Gender Male
Key inclusion criteria Patients who are going to receive radical surgery for prostate cancer
Key exclusion criteria patients who do not accept to join this trial
dementia
neurogenic bladder
serious organ dysfunction
dialysis
hemorrhoid
medical history of transurethral surgery, radiation or surgery of pelvic floor
chronic diarrhea and constipation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomonori Minagawa
Organization Shinshu University
Division name Urology
Zip code
Address 3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL +81263372661
Email minagawat@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonori Minagawa
Organization Shinshu University
Division name Urology
Zip code
Address 3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL +81263372661
Homepage URL
Email minagawat@shinshu-u.ac.jp

Sponsor
Institute University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2017 Year 03 Month 27 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 Completed
Date of protocol fixation
2017 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 03 Month 21 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030573

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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