UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026619
Receipt number 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 13:33:41

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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 or person

Institute

University

Institute

Department

Personal name



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

Value
https://center6.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