UMIN-CTR Clinical Trial

Public title

The effectiveness of the gentle mechanical skin stimulation for overactive bladder; a randomized, placebo-controlled, double-blind trial.

Acronym

The effectiveness of the gentle mechanical skin stimulation for overactive bladder.

Scientific Title

The effectiveness of the gentle mechanical skin stimulation for overactive bladder; a randomized, placebo-controlled, double-blind trial.

Scientific Title:Acronym

The effectiveness of the gentle mechanical skin stimulation for overactive bladder.

Region

Japan

Condition

Overactive bladder

Classification by specialty

Geriatrics

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We construct a new self-care model for overactive bladder using somatosensory stimulation, and clarify its effectiveness. In our previous study, the perineal skin stimulation with a roller that was performed by participants themselves at bedtime for three days reduced the nocturia frequency caused by overactive bladder. In this study, we examine the effects of long-term use of this self-administered method for future clinical application.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III

Primary outcomes

Urinary frequency per day before, during and after the intervention period.
The urinary frequency is calculated from time of urination recorded in urinary diary.

Key secondary outcomes

We assess the following outcomes during each period; before, during and after the intervention.
-Subjective symptoms of overactive bladder. (with Overactive Bladder Symptoms Score: OABSS)
-The influence of overactive bladder symptoms on daily life. (with King's Health Questionnaire: KHQ)
-The influence on sleep quality.
-Costs associated with care for frequent urination.
-Impression of the self-administered intervention (record during intervention periods only).
-volume of fluid intake (recorded on urinary diary)

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In intervention 1, the first three days-one week is the pre-intervention period that does not include intervention. The next 4 weeks are the intervention period. In intervention periods, participants stimulate perineal skin with an active roller (somaplane) by themselves. The subsequent 2 weeks are the follow-up period and, we observe conditions after stimulation.
Participants apply skin stimulation by themselves with an active roller following each urination as possible. This skin stimulation is applied slowly and gently on the perineal area for 1 minute using roller.
(If the study design is changed into a crossover design, the interventions 1 and 2 (see below) are performed for 2 weeks each. Washout period is 2 weeks between each intervention period. In intervention 1, participants use an active roller first, and use placebo roller after washout.)

Interventions/Control_2

In intervention 2, first three days-one week is the pre-intervention period that does not include intervention. The following 4 weeks are the intervention period. In the intervention period, participants stimulate the perineal skin with a placebo roller by themselves. The subsequent 2 weeks are the follow-up periods and we observe conditions after stimulation.
Participants apply skin stimulation by themselves with a placebo roller after each urination as possible. This skin stimulation is applied slowly and gently on the perineal area for 1 minute.
(If the study design is changed into a crossover design, the interventions 1 and 2 are performed for 2 weeks each. Washout period is 2 weeks between each intervention period. In intervention 2, participants use a placebo roller first, and use an active roller after washout.)

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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

-Having nocturnal urination one or more times.
-Having diagnosed with overactive bladder.
-Not taking anticholinergic drugs prescribed by a doctor for two weeks before trial registration.
-Being able to visit our hospital during study periods.
-Having agreement with their participation in writing.

Key exclusion criteria

-Having residual urine of more than 100ml.
-Having diagnosed with prostatic hyperplasia.
-Having the underlying disease such as bladder cancer, urinary calculi, inflammatory lower urinary tract.
-Having dementia suspects.
-Being considered in appropriate by a clinician.

Target sample size

16

Name of lead principal investigator

1st name	Yutaka
Middle name
Last name	Kasuya Yutaka

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Urology

Zip code

173-0015

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

TEL

03-3964-1141

Email

kasuya_yutaka@tmghig.jp

Name of contact person

1st name	Harumi
Middle name
Last name	Hotta

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Autonomic Neuroscience

Zip code

173-0015

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

TEL

03-3964-3241(4343)

Homepage URL

Email

hhotta@tmig.or.jp

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name

Organization

Tokyo Metropolitan Institute of Gerontology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Teikyo Heisei University

Name of secondary funder(s)

None

Organization

Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

Tel

03-3964-3241

Email

rinsyoushiken@tmghig.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京都健康長寿医療センター（東京都）/Tokyo Metropolitan Institute of Gerontology (Tokyo)

Date of disclosure of the study information

2016

Year

09

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Main results already published

Date of protocol fixation

2016

Year

07

Month

08

Day

Date of IRB

2016

Year

07

Month

08

Day

Anticipated trial start date

2016

Year

09

Month

09

Day

Last follow-up date

2017

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

09

Day

Last modified on

2020

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027615