Google Maps

NCT07734207

Overview

NCT ID: NCT07734207
Lead Sponsor: National Taiwan University HospitalOTHER
Official Title: A Novel Community-based Solution for Nocturia: Integrating Digital Technology and Multi-strategy Interventions
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Apr 8, 2026Actual
Primary Completion Date: Sep 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 50Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Shuai-Wen WangContact
y04186@ms1.ylh.gov.tw+886 929270729

Similar Studies

Participant Group/Arms

Intervention GroupExperimental

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 GroupNo Intervention

A general routine health eduation and follow-up