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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030684
Receipt No. R000034943
Scientific Title The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study
Date of disclosure of the study information 2018/03/15
Last modified on 2019/07/07

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Basic information
Public title The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study
Acronym The MORE study
Scientific Title The utility of penile compression device for the quality of life in Male urinary incOntinence after pRostatEctomy: A randomized prospective study
Scientific Title:Acronym The MORE study
Region
Japan

Condition
Condition Male urinary incOntinence after prostatectomy
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the utility of penile compression device for the quality of life in male urinary incontinence after prostatectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Changes of King's Health Questionnaire scores
Key secondary outcomes Changes in the number of urine pads used per day
Changes in the weight of urine pads per day

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use of the penile compression device for 28 days except at bedtime
Interventions/Control_2 No use of the penile compression device
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Patients who suffer from stress urinary incontinence after prostatectomy
Key exclusion criteria - Less than a month after prostatectomy
- Severe disease of penile skin
- After the implantation of artificial urinary sphincter
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Kazumasa
Middle name
Last name Torimoto
Organization Nara Medical University
Division name Department of Urology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email torimoto@naramed-u.ac.jp

Public contact
Name of contact person
1st name Kazumasa
Middle name
Last name Torimoto
Organization Nara Medical University
Division name Department of Urology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL http://www.naramed-u.ac.jp/~urol/
Email torimoto@naramed-u.ac.jp

Sponsor
Institute Department of Urology,
Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nara Medical University
Address 840 Shijo-cho, Kashihara, Nara
Tel 0744-22-3051
Email f-okumura@naramed-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 奈良県立医科大学附属病院(奈良県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 15 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 40
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
2018 Year 03 Month 08 Day
Date of IRB
2018 Year 03 Month 08 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 04 Month 09 Day
Date trial data considered complete
2019 Year 04 Month 10 Day
Date analysis concluded
2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034943

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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