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

Effects of gentle mechanical skin stimulation on nocturia: A double blind, randomized, cross-over trial - Development of a non-invasive skin stimulation technique effective for the prevention of frequent urination and urinary incontinence

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015809
Enrollment
60
Registered
2014-12-01
Start date
2014-01-10
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

nocturia

Interventions

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
, 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. For the preintervention recording
Intervention 2&quot
, 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.

Sponsors

Tokyo Metropolitan Institute of Gerontology
Lead Sponsor
Teikyo Heisei University
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactHotta Harumi

Tokyo Metropolitan Institute of Gerontology Autonomic Neuroscience

hhotta@tmig.or.jp03-3964-3241

Outcome results

None listed

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