Tokyo, June 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061555) titled 'A Study on the Feasibility of Pelvic Floor Muscle Training Using a Training Device for Elderly Patients with Urinary Incontinence' on June 8.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

Condition: Condition - Elderly patients with urinary incontinence Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

Eligibility: Age-lower limit - 65 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 Size - 27

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070081

Disclaimer: Curated by HT Syndication.