A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence

A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence - A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061555

Enrollment

Registered

2026-06-08

Start date

2026-04-13

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

Elderly patients with urinary incontinence

Interventions

Intervention Participants will undergo pelvic floor muscle training (PFMT) using the device Pelvit (Micron Co., Ltd.) for 15 minutes per session, five times per week, for three weeks. The interventio

a pressure sensor detects the contraction and displays pelvic floor muscle activity in real time, enabling intuitive visual feedback. The device does not deliver low-frequency stimulation or electrica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A) Aged 65 or older B) Individuals with urinary incontinence as identified by the Core Lower Urinary Tract Symptoms (CLSS) questionnaire

Exclusion criteria

Exclusion criteria: A) Individuals with suspected cognitive impairment who score less than 24 on the Mini-Mental State Examination for Japanese version (MMSE-J), which is difficult to administer B) Individuals with poor posture who have difficulty sitting in a chair C) Individuals with injuries or inflammation in the genital area D) Individuals wearing thick diapers

Design outcomes

Primary

Measure	Time frame
Completion rate was defined as the proportion of patients who were able to complete the intervention protocol, consisting of 15 minutes per day, five times per week, for three consecutive weeks. Patients who withdrew consent during the study were considered as not having completed the intervention and were included in the denominator for the calculation of the completion rate. Patients who were unable to complete the intervention due to adverse events for which a causal relationship with the intervention could not be ruled out were also included in the denominator as non-completers. In contrast, patients who discontinued the intervention due to deterioration in general health conditions deemed unrelated to the intervention, as judged by the attending physician, were treated as dropouts and excluded from the completion rate analysis. Similarly, patients who were unable to receive the intervention due to therapist-related reasons were classified as dropouts and excluded from the completion rate analysis.	—

Measure

Time frame

Completion rate was defined as the proportion of patients who were able to complete the intervention protocol, consisting of 15 minutes per day, five times per week, for three consecutive weeks. Patients who withdrew consent during the study were considered as not having completed the intervention and were included in the denominator for the calculation of the completion rate. Patients who were unable to complete the intervention due to adverse events for which a causal relationship with the intervention could not be ruled out were also included in the denominator as non-completers. In contrast, patients who discontinued the intervention due to deterioration in general health conditions deemed unrelated to the intervention, as judged by the attending physician, were treated as dropouts and excluded from the completion rate analysis. Similarly, patients who were unable to receive the intervention due to therapist-related reasons were classified as dropouts and excluded from the completion rate analysis.

—

Countries

Japan

Contacts

Public ContactMasaki Kamiya

National Center for Geriatrics and Gerontology Department of Rehabilitation

mkamiya@ncgg.go.jp0562-46-2311

Outcome results

None listed

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