UMIN-CTR Clinical Trial

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