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

July 23, 2026 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Douliu, Taiwan
        • Recruiting
        • Yunlin HI-HOPE Community Hub
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 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.
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.
No Intervention: Control Group
A general routine health eduation and follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nocturia Frequency
Time Frame: Baseline,3months,6months after randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Quality
Time Frame: Baseline,3months,6months after randomization
Measured using the PSQI Score that is a self-report questionnaire measuring sleep quality over the past month, with a total score ranging from 0 to 21.
Baseline,3months,6months after randomization
Mental Health
Time Frame: Baseline,3months,6months after randomization
Measured using the Center for Epidemiologic Studies Depression Scale-20 (CESD-20), a self-administered questionnaire assessing depressive symptoms.
Baseline,3months,6months after randomization
QoL
Time Frame: Baseline,3months,6months after randomization
Measured using the ICIQ-Nqol that is a patient-completed questionnaire evaluating quality of life (QoL) in patients with nocturia for use in research and clinical practice across the world.
Baseline,3months,6months after randomization
Fall and emergency
Time Frame: Baseline,3months,6months after randomization
Number of falls and emergency visit reported using an investigator-developed questionnaire.
Baseline,3months,6months after randomization
Anxiety
Time Frame: Baseline,3months,6months after randomization
Measured using the Generalized Anxiety Disorder-7 (GAD-7), a self-administered questionnaire assessing anxiety symptoms.
Baseline,3months,6months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

July 23, 2026

First Posted (Actual)

July 29, 2026

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202510038RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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