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Recruiting NCT07734207

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

No phase Interventional Nocturia Sleep Disturbanc Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home Uroflowmetry, Voiding Diary.
Who it may be relevant to
Registry conditions: Nocturia, Sleep Disturbanc, Quality of Life. Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Home 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.
  • Behavioral Voiding 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.

Primary outcome measures

  • Nocturia Frequency [Time frame: Baseline,3months,6months after randomization]
Secondary outcome measures (5)
  • Sleep Quality [Time frame: Baseline,3months,6months after randomization]
  • Mental Health [Time frame: Baseline,3months,6months after randomization]
  • QoL [Time frame: Baseline,3months,6months after randomization]
  • Fall and emergency [Time frame: Baseline,3months,6months after randomization]
  • Anxiety [Time frame: Baseline,3months,6months after randomization]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Yunlin HI-HOPE Community Hub — Douliu

Publications

  • Tsai VFS, Tsai YC, Yang SSD, Li MW, Pong YH, Tsai YT. An Emerging Trend of At-Home Uroflowmetry-Designing a New Vibration-Based Uroflowmeter with Artificial Intelligence Pattern Recognition of Uroflow Curves and Comparing with Other Technologies. Diagnostics (Basel). 2025 Jul 21;15(14):1832. doi: 10.3390/diagnostics15141832. PMID 40722581

Identifiers

NCT: NCT07734207 · 202510038RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗