UMIN-CTR Clinical Trial

Public title

Effects of gentle mechanical skin stimulation on nocturia: A double blind, randomized, cross-over trial

Acronym

Development of a non-invasive skin stimulation technique effective for the prevention of frequent urination and urinary incontinence

Scientific Title

Effects of gentle mechanical skin stimulation on nocturia: A double blind, randomized, cross-over trial

Scientific Title:Acronym

Development of a non-invasive skin stimulation technique effective for the prevention of frequent urination and urinary incontinence

Region

Japan

Condition

nocturia

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To develop a new non-drug therapy which can ameliorate frequent urination and urinary incontinence in elderly people, which are key geriatric syndromes, this study aimed to elucidate the impact of gentle stimulation of the perineal skin on the frequency of nighttime urination in patients with nocturia.
Stimulation was delivered using a soft elastomer roller (real roller) and a hard-surface roller (placebo roller);
the former exhibited an inhibitory effect on micturition contractions of the urinary bladder in an animal experiment and the latter did not.
The results were then compared between the two rollers.

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 night calculated based on the number of nighttime voids during the pre-intervention period and each of the three-day roller stimulation periods.

Key secondary outcomes

Determination of the presence or absence of overactive bladder using a questionnaire on the symptoms of overactive bladder (pre-intervention and post-intervention); a questionnaire on self-care (post-intervention); salivary hormone levels during intervention [melatonin, cortisol, and chromogranin A] (pre-intervention/post-intervention); a questionnaire on quality of life [N-QOL] (post-intervention);
and a questionnaire on sleep (post-intervention).

Study type

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

For the preintervention period, the number of urinations during nighttime sleeping hours are recorded for three consecutive nights.
Then, the subjects apply skin stimulation to the perineal region on their own for one minute each night before going to bed using the roller provided by a study representative.
The number of urinations after going to bed are also recorded every night during each of the stimulation periods.
In "Intervention 1", the real roller is used first for three consecutive nights, followed by a four-night washout period.
Then, the placebo roller is used for three consecutive nights.

Interventions/Control_2

For the preintervention recording, the number of urinations during nighttime sleeping hours are recorded for three consecutive nights.
Then, the subjects apply skin stimulation to the perineal region on their own for one minute each night before going to bed using the roller provided by a study representative.
The number of urinations after going to bed are also recorded every night during each of the stimulation periods.
In "Intervention 2", the placebo roller is used first for three consecutive nights, followed by a four-night washout period.
Then, the real roller is used for three consecutive nights.

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

50

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Elderly women with nocturia (awakening more than twice for urination during nighttime sleeping hours).
Those who received a doctor's approval to participate in the experiment based on the results of medical examinations conducted during the preintervention period.

Key exclusion criteria

Those who did not receive a doctor's approval to participate in the experiment based on the results of medical examinations conducted during the preintervention period.
Those who are not capable of coming to the study sites (hospitals and research facilities) on their own.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Kasuya Yutaka

Organization

Tokyo Metropolitan Geriatric Hospital

Division name

Urology

Zip code

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

TEL

03-3964-1141

Email

kasuya_yutaka@tmghig.jp

Name of contact person

1st name
Middle name
Last name	Hotta Harumi

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Autonomic Neuroscience

Zip code

Address

35-2 Sakaecho, Itabashi-ku, Tokyo

TEL

03-3964-3241

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

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

東京都健康長寿医療センター（東京都）

Date of disclosure of the study information

2014

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Among a total of 22 patients who completed the entire investigation schedule, those with overactive bladder symptoms (9 patients) experienced a significant decrease in nighttime urinary frequency during the period of real roller stimulation, by approximately 0.6 times per night, as compared to that during the period of the pre-intervention or during the placebo roller stimulation.

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

2013

Year

12

Month

04

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

10

Day

Last follow-up date

2014

Year

03

Month

14

Day

Date of closure to data entry

2014

Year

08

Month

21

Day

Date trial data considered complete

2014

Year

08

Month

21

Day

Date analysis concluded

2014

Year

08

Month

21

Day

Other related information

Registered date

2014

Year

12

Month

01

Day

Last modified on

2014

Year

12

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018278