UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009961 |
|---|---|
| Receipt number | R000011665 |
| Scientific Title | Effectiveness of pelvic floor muscle exercise for urinary continence after radical prostatectomy: An analysis on optimal introduction time. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2014/02/05 10:45:57 |
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Basic information
Public title
Effectiveness of pelvic floor muscle exercise for urinary continence after radical prostatectomy: An analysis on optimal introduction time.
Acronym
Pelvic floor exercise for continence after prostatectomy.
Scientific Title
Effectiveness of pelvic floor muscle exercise for urinary continence after radical prostatectomy: An analysis on optimal introduction time.
Scientific Title:Acronym
Pelvic floor exercise for continence after prostatectomy.
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of pelvic floor muscle exercise for urinary incontinence after radical prostatectomy and to determine its optimal introduction time to the patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
International Prostate Symptom Score, International Consultation on Incontinence Questionnaire-Short Form,
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pelvic floor muscle exercise
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who undergo radical
prostatectomy at our institution
Key exclusion criteria
Patients who don't consent to this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mifumi Nakajima |
Organization
National cancer research center east hospital
Division name
Nursing department
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba,Japan
TEL
04-7133-1111
miono@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mifumi Nakajima |
Organization
National cancer research center east hospital
Division name
Nursing department
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa-shi, Chiba,Japan
TEL
04-7133-1111
Homepage URL
miono@east.ncc.go.jp
Sponsor or person
Institute
Department of Nursing Care, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
None declared
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
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
| 2013 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2014 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011665
