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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023991
Enrollment
16
Registered
2016-09-12
Start date
2016-09-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive bladder

Interventions

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

Sponsors

Tokyo Metropolitan Institute of Gerontology
Lead Sponsor
Teikyo Heisei University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactHarumi Hotta

Tokyo Metropolitan Institute of Gerontology Autonomic Neuroscience

hhotta@tmig.or.jp03-3964-3241(4343)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026