UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025143 |
|---|---|
| Receipt number | R000028059 |
| Scientific Title | The effect of individualised pelvic floor muscle training for post-prostatectemy patients. |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2021/02/02 09:55:47 |
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Basic information
Public title
The effect of individualised pelvic floor muscle training for post-prostatectemy patients.
Acronym
The effect of individualised pelvic floor muscle training
Scientific Title
The effect of individualised pelvic floor muscle training for post-prostatectemy patients.
Scientific Title:Acronym
The effect of individualised pelvic floor muscle training
Region
| Japan |
Condition
Condition
Prostatic Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of individualized pelvic floor muscle training on recovery from urinary incontince after Robotics Assisted Laparoscopic Prostatectomy (RALP)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
24-hour pad test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Individualized pelvic floor muscle training from 2-months before operation to 12-months after oeration
Interventions/Control_2
Group excercise
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. Over 20 years old patients
2. Patients with more than one months before operation
3. The patients who can consent to research participation voluntarily
Key exclusion criteria
1. Patients with serious disease
2. Patients with psychiatric disease
3. Patients with lower urinary tract infection
4. Judged as not being suitable to this study by the doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Shinohara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
nozomis@mbj.nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeya Kitta |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
Homepage URL
kitta@fb3.so-net.ne.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2016 | Year | 12 | Month | 05 | 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 | 09 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 12 | Month | 05 | Day |
Last modified on
| 2021 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028059
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
