UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of an ultrasound urine volume monitor (Lilium alpha-200) in evaluation of lower urinary tract dyfunction
Acronym	Efficacy of an ultrasound urine volume monitor
Scientific Title	Efficacy of an ultrasound urine volume monitor (Lilium alpha-200) in evaluation of lower urinary tract dyfunction
Scientific Title:Acronym	Efficacy of an ultrasound urine volume monitor
Region	Japan

Condition
Condition	benign prostate hyperplasia, neurogenic bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess the efficacy of an ultrasound urine volume monitor in evaluation of lower urinary tract dysfunction in patients with benign prostate hyperplasia or neurogenic bladder
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	consistency of voiding record obtained by an ultrasound urine volume monitor with voiding diary
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 and Female
Key inclusion criteria	hospitalized patients with urodynamically proven benign prostatic obstruction or neurogenicnbladder older than 20 years
Key exclusion criteria	patients with urinary retention, patients undergoing intermittent catheterization
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Momokazu Middle name Last name Gotoh
Organization	Department of Urology, Nagoya University Graduate School of Medicne
Division name	Urology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2984
Email	gotoh@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Momokazu Middle name Last name Gotoh
Organization	Nagoya University Graduate School of Medicne
Division name	Urology
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2984
Homepage URL
Email	gotoh@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Urology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Liliam Otsuka
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics Committee, Nagoya University Graduate School of Medicine
Address	65 Tsurumai-cho, Nagoya
Tel	0527442984
Email	gotoh@med.nagoya-u.ac.jp

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	2015 Year 11 Month 02 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	No longer recruiting
Date of protocol fixation	2015 Year 11 Month 02 Day
Date of IRB	2015 Year 11 Month 10 Day
Anticipated trial start date	2015 Year 12 Month 10 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information	To assess the voiding records for 24 hours (time to void, changes of bladder volume)by a ultrasound urine volume monitor (Lilium alpha-200) and a frequency-volume chart, and to measure residual urine volume. Cohort study. All patients who consult Nagoya University and Ohita University hospitals and meet the inclusion cliteria will be included, between Dec.2015 and Dec. 2016.

Management information
Registered date	2015 Year 11 Month 02 Day
Last modified on	2020 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022665