UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Flow dynamic assessment of lower urinary tract using vector flow mapping
Title of the study (Brief title)	Flow dynamic assessment of LUT using VFM
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish methodology to evaluate fluid dynamic assessment of LUT
Basic objectives2	Others
Basic objectives -Others	Flow dynamical assessment of urine steam has not established yet. Herein ,we attempt to visualize urine flow in urinary bladder using VFM.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visualization of urine stream in urinary bladder
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male
Key inclusion criteria	Less than 7 of IPSS
Key exclusion criteria	Benign prostate hyperplasia more than 40 cm3
Target sample size	2

Research contact person
Name of lead principal investigator	Tomonori Minagawa
Organization	Shinshu University, School of Medicine
Division name	Urology
Address	3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL	0263-37-2661
Email	minagawat@shinshu-u.ac.jp

Public contact
Name of contact person	Tomonori Minagawa
Organization	Shinshu University, School of Medicine
Division name	Urology
Address	3-1-1 Asahi, Matsumoto city, Nagano, Japan
TEL	0263-37-2661
Homepage URL
Email	minagawat@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

Funding Source
Organization	Department of Urology, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2018 Year 12 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 01 Day
Anticipated trial start date	2018 Year 09 Month 05 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	Analysis of image data obtained by ultrasonography

Management information
Registered date	2018 Year 12 Month 16 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040182