UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study on the relationship between frailty and detrusor underactivity
Title of the study (Brief title)	Frailty and detrusor underactivity
Region	Japan

Condition
Condition	Frailty
Classification by specialty	Geriatrics Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of frailty on bladder function.
Basic objectives2	Others
Basic objectives -Others	To investigate whether prevention or treamtment of frailty affects bladder function
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between frailty and detrusor contractility
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom
Interventions/Control_1	Rehabilitation and nutritional guidance for frailty
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	a) patients having lower urinary tract symptoms b) patients who can visit the hospital on foot c) patietns with 5 out of 6 items in Kats Index showing "independent" and Frailty index showing 2 or more points. d) patients who understand the study and provide written informed consent.
Key exclusion criteria	a) quadriplegic patients b) patients who were diagnosed as demetia or treated with anti-dementia drug. c) patients in a condition of need for long-term care (primary nursing care requirement authorization category 1-5) d) patients with neurological diseases or spine disorders e) patients who underwent pelvic surgeries f) patients who are not suitable for body composition meter (BCI) g) patients who are not capable of providing written informed consent h) patients who are considered to be unsuitable for the study by primary doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Tsuyoshi Majima
Organization	Nagoya University Graduate School of Medicine
Division name	Urology
Address	65, Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi-ken
TEL	0527442984
Email	majima@med.nagoya-u.ac.jp

Public contact
Name of contact person	Tsuyoshi Majima
Organization	Nagoya University Graduate School of Medicine
Division name	Urology
Address	65, Tsurumai-cho, Showa-ku, Nagoya-shi, Aichi-ken
TEL	0527442984
Homepage URL
Email	majima@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2019 Year 02 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2019 Year 01 Month 15 Day
Last modified on	2019 Year 01 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040453