UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045736 |
|---|---|
| Receipt number | 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 19:19:05 |
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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
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
s-kumagai@fujita-hp.jp
Sponsor or person
Institute
Fujita general hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052208
