UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022591 |
|---|---|
| Receipt number | R000026038 |
| Scientific Title | Comparison of a new compact hydrophilic-coated catheter and a conventional non-coated catheter in ease of use for intermittent catheterization: a prospective randomized cross-over study in male patients |
| Date of disclosure of the study information | 2016/06/03 |
| Last modified on | 2019/06/07 10:34:25 |
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Basic information
Public title
Comparison of a new compact hydrophilic-coated catheter and a conventional non-coated catheter in ease of use for intermittent catheterization: a prospective randomized cross-over study in male patients
Acronym
The COMPACT Study
Scientific Title
Comparison of a new compact hydrophilic-coated catheter and a conventional non-coated catheter in ease of use for intermittent catheterization: a prospective randomized cross-over study in male patients
Scientific Title:Acronym
The COMPACT Study
Region
| Japan |
Condition
Condition
Neurogenic bladder or Benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison in ease of use
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intermittent Self-Catheterization Questionnaire after the use of the two types of catheter for 2 weeks
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
hydrophilic-coated catheter or non-coated catheter
Interventions/Control_2
two weeks for a type of catheter
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
| 75 | years-old | > |
Gender
Male
Key inclusion criteria
1. Intermittent catheterization is necessary.
2. Neurogenic bladder or benign prostatic hyperplasia is diagnosed.
Key exclusion criteria
Assistance with catheterization is necessary.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazumasa Torimoto |
Organization
Nara Medical University Hospital
Division name
Department of Urology
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
torimoto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Kasahara |
Organization
Nara Medical University Hospital
Division name
Clinical Research Center
Zip code
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kasa@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Coloplast
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
Address
Tel
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
| 2016 | Year | 06 | Month | 03 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026038
