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

NCT07734207 | Recruiting

• 1 other identifier: 202510038RIND
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nocturia; Sleep Disturbanc; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Nocturia Frequency

  Analyze changes in the frequency of nocturia by Overactive Bladder Symptom Score(OABSS) that is a validated, four-question diagnostic tool used to assess the severity of overactive bladder (OAB) symptoms based on daytime frequency, night-time frequency, urgency, and urge incontinence.

  Baseline,3months,6months after randomization

Secondary Outcomes (5)

• Sleep Quality

  Baseline,3months,6months after randomization

• Mental Health

  Baseline,3months,6months after randomization

• QoL

  Baseline,3months,6months after randomization

• Fall and emergency

  Baseline,3months,6months after randomization

• Anxiety

  Baseline,3months,6months after randomization

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Device: Home Uroflowmetry; Behavioral: Voiding Diary

Control Group

NO INTERVENTION

A general routine health eduation and follow-up

Interventions

Home Uroflowmetry DEVICE

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.

Intervention Group

Voiding Diary BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Yunlin HI-HOPE Community Hub

Douliu, Taiwan

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shuai-Wen Wang

CONTACT

+886 929270729; y04186@ms1.ylh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: July 29, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)