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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017963
Receipt No. R000020774
Scientific Title Ultrasound-assisted Prompted Voiding for Incontinent Elderly Living in Geriatric Health Services Facilities
Date of disclosure of the study information 2015/06/22
Last modified on 2019/01/11

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Basic information
Public title Ultrasound-assisted Prompted Voiding for Incontinent Elderly Living in Geriatric Health Services Facilities
Acronym Ultrasound-assisted Prompted Voiding for Incontinent Elderly
Scientific Title Ultrasound-assisted Prompted Voiding for Incontinent Elderly Living in Geriatric Health Services Facilities
Scientific Title:Acronym 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
1st name
Middle name
Last name Homma, Yukio
Organization Japanese Society of Geriatric Urology
Division name Chair
Zip code
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
1st name
Middle name
Last name Miyazaki, Hideyo
Organization Japanese Society of Geriatric Urology
Division name Secretary-general
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2015 Year 03 Month 12 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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