UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030759 |
|---|---|
| Receipt number | R000035125 |
| Scientific Title | A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence after Radical Prostatectomy for prostate cancner |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/11/23 13:06:23 |
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Basic information
Public title
A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence after Radical Prostatectomy for prostate cancner
Acronym
A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence
Scientific Title
A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence after Radical Prostatectomy for prostate cancner
Scientific Title:Acronym
A Study on the Usefulness of Penile Clamping Device for Urinary Incontinence
Region
| Japan |
Condition
Condition
post-prostatectomy urinary incontinence
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of usefulness of penis clamping device for post-prostatectomy urinary incontinence
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient satisfaction
Key secondary outcomes
complication
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
Key inclusion criteria
male post-prostatectomy urinary incontinence, 20 or more age, with consent
Key exclusion criteria
no urinary incontinence
non-compliance
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji MAEDA |
Organization
Matto Central Hospital
Division name
Urology
Zip code
Address
Kuramitsu 3-8, Hakusan, Ishikawa
TEL
076-275-2222
y-maeda@mattohp.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji MAEDA |
Organization
Matto Central Hospital
Division name
Urology
Zip code
Address
Kuramitsu 3-8, Hakusan, Ishikawa
TEL
076-275-2222
Homepage URL
y-maeda@mattohp.com
Sponsor or person
Institute
Matto Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Matto Central Hospital
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 01 | 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
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
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 04 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 05 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035125
