UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019612 |
|---|---|
| Receipt number | R000022665 |
| Scientific Title | Efficacy of an ultrasound urine volume monitor (Lilium alpha-200) in evaluation of lower urinary tract dyfunction |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2020/05/06 10:14:37 |
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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
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
gotoh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Urology, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
