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

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 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


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

Value
https://center6.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