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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025143
Receipt No. 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 2019/10/30

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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
Email 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
Email kitta@fb3.so-net.ne.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

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
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 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 No longer recruiting
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
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028059

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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