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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003140
Receipt No. R000003787
Scientific Title Development of a new surgical method for post prostatectomy urinary incontinence
Date of disclosure of the study information 2010/02/04
Last modified on 2015/08/07

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Basic information
Public title Development of a new surgical method for post prostatectomy urinary incontinence
Acronym Development of a new surgical method for post prostatectomy urinary incontinence
Scientific Title Development of a new surgical method for post prostatectomy urinary incontinence
Scientific Title:Acronym Development of a new surgical method for post prostatectomy urinary incontinence
Region
Japan

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

Objectives
Narrative objectives1 Investigation of efficacy and safety of the new Yamada procedure for post prostatectomy urinary incontinence
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improved rate of urinary incontinence
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgical operation
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 Male
Key inclusion criteria Post prostatectomy urinary incontinence over one year
Key exclusion criteria Poor prognosis of prostate cancer less than two years
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takumi Yamada
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Urology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3403
Email t_yamada@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takumi Yamada
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Urology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3403
Homepage URL
Email t_yamada@saitama-med.ac.jp

Sponsor
Institute Department of Urology, Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Urology, Saitama Medical Center, Saitama Medical University
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 埼玉医科大学総合医療センター

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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
2010 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 04 Day
Last modified on
2015 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003787

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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