UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Ultrasound-assisted Prompted Voiding for Incontinent Elderly Living in Geriatric Health Services Facilities
Title of the study (Brief title)	Ultrasound-assisted Prompted Voiding for Incontinent Elderly
Region	Japan

Condition
Condition	Elderly with urinary incontinence using diapers or pads in intermediary institutions between the hospital and the home in Japan (Geriatric Health Services Facilities)
Classification by specialty	Geriatrics Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess individually-tailored ultrasound-assisted prompted voiding as a means of managing urinary incontinence of elderly in intermediary institutions between the hospital and the home in Japan. The hypothesis is that ultrasound-assisted prompted voiding is better in managing incontinence than conventional prompted voiding.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of urinary leakage and QOL assessed by EQ-5D before and after intervention (8 weeks)
Key secondary outcomes	Cognitive function, mental state, physical function and level of motivation will be assessed for elderly with urinary incontinence by MMSE (Mini-Mental State Examination), GDS (Geriatric Depression Score), Barthel Index, and Vitality index before and after intervention (8 weeks). QOL of caregivers and burden on caregivers with regard to continence care will be assessed by SF-12v2 and VAS scale respectively, before and after the study (6 months).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Control group; The elderly, 20 at each institution, will have a frequency volume chart before the study starts. Their voided volume, the volume of urinary incontinence measured with a scale, and the residual urine volume measured with a portable ultrasound device (BladderScan BVI6100; Verathon, Bothell, WA, USA) will be recorded during one day in a frequency volume chart. Their complication, QOL, cognitive function, mental state, existence of depression, physical function, and level of motivation will be assessed by Charlson Comorbidity Index, EQ-5D, MMSE (Mini-Mental State Examination), GDS (Geriatric Depression Score), Barthel Index, and Vitality index respectively. During 8 weeks, they will have the prompted voiding which means that they will be asked to void every approximately 2 hours. The elderly individuals will also be allowed to void when they have desire to void. After 8 weeks, they will have a frequency volume chart again and the volume of urinary incontinence will be assessed. Their QOL, cognitive function, mental state, physical function, and level of motivation will be assessed by the same questionnaires as above.
Interventions/Control_2	Interventional group; The elderly, 20 at each institution, will have a frequency volume chart before the study starts. Their voided volume, the volume of urinary incontinence measured with a scale, and the residual urine volume measured with a portable ultrasound device (BladderScan BVI6100; Verathon, Bothell, WA, USA) will be recorded during one day in a frequency volume chart. Their complication, QOL, cognitive function, mental state, existence of depression, physical function, and level of motivation will be assessed by Charlson Comorbidity Index, EQ-5D, MMSE (Mini-Mental State Examination), GDS (Geriatric Depression Score), Barthel Index, and Vitality index respectively. According to the frequency volume chart, the optimal bladder volume for the each elderly will be decided. During 8 weeks the elderly individuals will receive the ultrasound-assisted prompted voiding care; caregivers measure the urinary volume in the bladder periodically (ca, every two hours) and prompt the elderly individuals to void when the estimated volume in the bladder is more than 75 % of the individuals' optimal bladder volume. During 8 weeks, caregivers will use a portable ultrasound device at least once a day to measure the volume of urine in the bladder. Elderly in this group will have a frequency volume chart once a week. After 8 weeks, they will have a frequency volume chart again and the volume of urinary incontinence will be assessed. Their QOL, cognitive function, mental state, physical function, and level of motivation will be assessed by the same questionnaires as above.
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly older than 65 years old living in intermediary institutions between the hospital and the home in Japan (Geriatric Health Services Facilities) who have urinary incontinence and use diapers or pads during daytime
Key exclusion criteria	Elderly in a critical condition, bedridden, with urinary tract infection The residual urine volume after void more than 300ml
Target sample size	300

Research contact person
Name of lead principal investigator	Homma, Yukio
Organization	Japanese Society of Geriatric Urology
Division name	Chair
Address	7-3-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8753
Email	homma-uro@umin.ac.jp

Public contact
Name of contact person	Miyazaki, Hideyo
Organization	Japanese Society of Geriatric Urology
Division name	Secretary-general
Address	7-3-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL	03-5800-8753
Homepage URL
Email	jsgu-hq@umin.ac.jp

Sponsor
Institute	Japanese Society of Geriatric Urology
Institute
Department

Funding Source
Organization	None
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	2015 Year 06 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 12 Day
Anticipated trial start date	2015 Year 06 Month 22 Day
Last follow-up date	2016 Year 11 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2015 Year 06 Month 18 Day
Last modified on	2019 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020774