UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of urethral function after radical prostatectomy using ultrasonography
Title of the study (Brief title)	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	Tomonori Minagawa
Organization	Shinshu University
Division name	Urology
Address	3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL	+81263372661
Email	minagawat@shinshu-u.ac.jp

Public contact
Name of contact person	Tomonori Minagawa
Organization	Shinshu University
Division name	Urology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030573