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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022591
Receipt No. 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

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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
Email 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
Email kasa@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026038

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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