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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000045736
Receipt No. R000052208
Scientific Title Elucidation of the pathophysiology of post-prostatectomy urunary incontinence by cine MRI
Date of disclosure of the study information 2021/10/12
Last modified on 2021/10/12

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Basic information
Public title Evaluation of the effect of levator ani muscle contraction
on post-prostatectomy urinary incontinence using cine
MRI
Acronym LAMC on PPI study
Scientific Title Elucidation of the pathophysiology of post-prostatectomy urunary incontinence by cine MRI
Scientific Title:Acronym PPPI study
Region
Japan

Condition
Condition prostate cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Post-prostatectomy urinary incontinence (PPI) is the greatest concern for urologists after radical prostatectomy. It is thought that PPI is composed of multiple factors including static and dynamic components. The purpose of this study was to show visually LAM contraction during PFMC and to evaluate the dynamic differences in its contraction between men with and without PPI.
Basic objectives2 Others
Basic objectives -Others The purpose is to develop a new method of radical prostatectomy to recover postoperative urinary incontinence at an early stage.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of relationship between the presence or absence of PPI and the grade of levator ani muscle contraction
Key secondary outcomes

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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria Those who undergo prostate biopsy on suspicion of prostate cancer, those who have recovered from urinary incontinence 6 months after prostatectomy, and those who continue to have urinary leakage more than 2 years after prostatectomy
Key exclusion criteria Those who have relapsed after prostatectomy and received radiation therapy
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shin
Middle name
Last name Kumagai
Organization Fujita general hospital
Division name urology
Zip code 969-1793
Address 14 Tsukanome Sanbongi, Kunimi town, Date district, Fukushima Prefecture 969-1793, Japan.
TEL 024-585-2121
Email s-kumagai@fujita-hp.jp

Public contact
Name of contact person
1st name Shin
Middle name
Last name Kumagai
Organization Fujita general hospital
Division name urology
Zip code 969-1793
Address 14 Tsukanome Sanbongi, Kunimi town, Date district, Fukushima Prefecture 969-1793, Japan.
TEL 024-585-2121
Homepage URL
Email s-kumagai@fujita-hp.jp

Sponsor
Institute Fujita general hospital
Institute
Department

Funding Source
Organization no
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 Fujita general hospital ethics comittee
Address 14 Tsukanome Sanbongi, Kunimi town, Date district, Fukushima Prefecture 969-1793, Japan.
Tel 024-585-2121
Email info@fujita-hp.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

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
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 Main results already published
Date of protocol fixation
2017 Year 10 Month 01 Day
Date of IRB
2019 Year 09 Month 01 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The observation period has ended, and some of the data were presented at the annual meeting of the Japanese Urological Association in December 2020.

Management information
Registered date
2021 Year 10 Month 12 Day
Last modified on
2021 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052208

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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