UMIN-CTR Clinical Trial

Basic information
Public title	Studies of post-operative patients's stress biomarkers using sitting pressure reduction device : fuwatto
Acronym	Studies of post-operative patients's stress biomarkers using sitting pressure reduction device : fuwatto
Scientific Title	Studies of post-operative patients's stress biomarkers using sitting pressure reduction device : fuwatto
Scientific Title:Acronym	Studies of post-operative patients's stress biomarkers using sitting pressure reduction device : fuwatto
Region	Japan

Condition
Condition	Urological diseases in general
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to evaluate the reduction effect of postoperative patients's stress using sitting stress reduction device fuwatto. A questionnaire is used for subjective evaluation, and stress biomarkers are analyzed in saliva, blood, and urine samples as objective evaluation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Before the surgery, 1 day after the surgery, 1 week after the surgery, fill out the questionnaire at the time of discharge and collect samples of saliva, blood and urine.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Wearing a seat pressure relief device "Fuwat" after surgery for 1 week to 10 days.
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	20 years-old <
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing Robotic-assisted radical prostatectomy:male. Patients undergoing Pelvic Organ Prolapse and stress incontinence surgery :female Patients under urethral catheterization
Key exclusion criteria	Patients who do not wish to participate in this study. Patients who the attending physician has determined to be unable to participate in the study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Mitsuru Middle name Last name Noguchi
Organization	Saga University Faculty of Medicine
Division name	Department of Urology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2344
Email	nogman@cc.saga-u.ac.jp

Public contact
Name of contact person	1st name Maki Middle name Last name Kawasaki
Organization	Saga University Faculty of Medicine
Division name	Department of Urology
Zip code	849-8501
Address	5-1-1 Nabeshima, Saga
TEL	0952-34-2344
Homepage URL
Email	kawasakm@cc.saga-u.ac.jp

Sponsor
Institute	Saga University Faculty of Medicine
Institute
Department

Funding Source
Organization	Saga University Faculty of Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical research center, Saga university hospital
Address	5-1-1 Nabeshima, Saga
Tel	0952-34-3357
Email	kenkyu-shinsei@ml.cc.saga-u.ac.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	2020 Year 09 Month 10 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	Enrolling by invitation
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB	2020 Year 10 Month 05 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2025 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	2020 Year 09 Month 09 Day
Last modified on	2021 Year 03 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047485