UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical applications of non invasive Doppler ultrasound urodynamic study
Title of the study (Brief title)	Doppler ultrasound urodynamic study
Region	Japan

Condition
Condition	Benign prostatic hypertrophy Neurogenic bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess reliability of evaluation for lower urinary tract function using Doppler ultrasound urodynamic study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ratio of cases who can be measured velocity related parameters against total number of cases studied.
Key secondary outcomes	Functional cross sectional area at prostatic urethra (A1) Velocity ratio (VR: Velocity above the sphincter divided by that below it)

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Ultrasound probe positioning using a remote controlled robotic manipultor
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 and Female
Key inclusion criteria	Agreement of the patient
Key exclusion criteria	Patients who cannot void on the ultrasound probe at the perineal region.
Target sample size	300

Research contact person
Name of lead principal investigator	Hideo Ozawa
Organization	Mizushima Central Hospital
Division name	Department of Urology
Address	4-5 Mizushima-aoba chou, Kurashiki, Okayama
TEL	086-444-3311
Email	UrOzawa@aol.jp

Public contact
Name of contact person	Hideo Ozawa
Organization	Mizushima Central Hospital
Division name	Department of Urology
Address	4-5 Mizushima-aoba chou, Kurashiki, Okayama
TEL	81864443311
Homepage URL
Email	UrOzawa@aol.jp

Sponsor
Institute	Kawasaki Medical School General Medical Center
Institute
Department

Funding Source
Organization	Kawasaki Hospital, Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	1509
Org. issuing International ID_1	Kawasaki Medical School
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	川崎医科大学川崎総合医療センター（岡山県）

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 07 Month 29 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 01 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 29 Day
Last modified on	2017 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013253