RecruitingNot ApplicableNCT07734207

A Community-based Solution for Nocturia: Integrating Digital Technology and Behavioral Interventions

A Novel Community-based Solution for Nocturia: Integrating Digital Technology and Multi-strategy Interventions

Sponsor

National Taiwan University Hospital

Enrollment

50 participants

Start Date

Apr 8, 2026

Study Type

INTERVENTIONAL

Conditions

Nocturia Quality of Life Sleep Disturbanc

Summary

Nocturia is a prevalent and distressing condition among older adults in Taiwan, significantly impacting sleep quality, mental health, and fall risks. This pilot study evaluates a novel community-based management model that integrates digital health technology with behavioral therapy. Participants aged 55 years or older experiencing nocturia (≥2 voids/night) will be cluster-randomized into an intervention group or a control group. The intervention group will utilize a voiding diary and a non-contact home uroflowmetry (HUFM) device to track voiding patterns and receive real-time feedback. This data-driven approach is combined with personalized lifestyle guidance (e.g., fluid restriction and leg elevation) and psychiatric screening for sleep and mood disorders. The primary objective is to evaluate the reduction in nocturnal voids and improve quality of life, while exploring the potential to reduce dependence on medications.

Eligibility

Min Age: 55 Years

Inclusion Criteria2

Baseline nocturia frequency ≥ 2 times/night (confirmed by subjective report or simplified questionnaire).
Ability to operate LINE on a smartphone or have a caregiver assist with completing the electronic urinary diary.

Exclusion Criteria6

Acute urinary tract infection
Uncontrolled heart failure
Serum sodium < 130 mEq/L
Underwent urological surgery within the past three months
Major psychiatric or neurological disorder in an active phase, (GDS-15>5)
Participation in other clinical trials related to nocturia

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Interventions

DEVICEHome Uroflowmetry

This intervention involves the use of an electronic urine record device that tracks nocturia episodes. The device syncs with a digital app, providing real-time feedback and allowing participants to monitor their urinary patterns. This intervention aims to help participants better understand their nocturia and improve lifestyle management strategies, including sleep hygiene and fluid intake control.

BEHAVIORALVoiding Diary

By recording fluid intake, voiding time, urine volume and urinary incontinence for 2-3 consecutive days each month over a 6-month period. It helps research group accurately analyze the condition, distinguish between bladder function problems and Polyuria, and evaluate treatment effectiveness.