UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061555 |
|---|---|
| Receipt number | R000070081 |
| Scientific Title | A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/05/08 15:43:32 |
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Basic information
Public title
A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence
Acronym
A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence
Scientific Title
A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence
Scientific Title:Acronym
A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence
Region
| Japan |
Condition
Condition
Elderly patients with urinary incontinence
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Urinary incontinence is common among older adults and lowers quality of life. Pelvic floor muscle training is first-line but difficult, especially with cognitive decline and poor adherence. We evaluated the feasibility of a pressure-sensor biofeedback PFMT device in older patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
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 intervention will be conducted within the scope of routine clinical practice and in accordance with the approved indications for device use under health insurance.
Pelvic floor muscle training device (Pelvit)
Pelvit is a device designed to facilitate PFMT for the improvement of urinary incontinence. Users contract their pelvic floor muscles in accordance with a visual graph displayed on a screen; 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 electrical energy, nor is it intended for electromyographic measurement.
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A) Aged 65 or older
B) Individuals with urinary incontinence as identified by the Core Lower Urinary Tract Symptoms (CLSS) questionnaire
Key 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
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Rehabilitation
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kamiya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi
TEL
0562-46-2311
Homepage URL
mkamiya@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Terumo Life Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi
Tel
0562-46-2311
itom@ncgg.go.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 13 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070081
