UMIN-CTR Clinical Trial

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

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

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

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).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Japanese Society of Geriatric Urology

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Published

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

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 related information

Registered date

2015

Year

06

Month

18

Day

Last modified on

2019

Year

01

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020774