UMIN-CTR Clinical Trial

Basic information
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
Condition	Overactive bladder
Classification by specialty	Geriatrics Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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)

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Institute of Gerontology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Teikyo Heisei University
Name of secondary funder(s)	None

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

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

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	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
Other related information

Management information
Registered date	2016 Year 09 Month 09 Day
Last modified on	2020 Year 03 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027615