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

NCT07734207 — Not applicable, Recruiting, 50 participants, National Taiwan University Hospital

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

Registry	NCT07734207
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	National Taiwan University Hospital (Other)
Conditions	Nocturia, Sleep Disturbanc, Quality of Life
Interventions	Home Uroflowmetry, Voiding Diary (Device, behavioral)
Dates	start 2026-04-08, primary completion 2026-09-30 (estimated), completion 2027-03-31 (estimated), first posted 2026-07-29, last updated 2026-07-29
Locations	1 site in Taiwan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention Group	Experimental	Device: Home Uroflowmetry; Behavioral: Voiding Diary	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.
Control Group	No intervention		A general routine health eduation and follow-up

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.
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.

+Outcome measures

Primary outcomes

Nocturia Frequency [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.

Secondary outcomes

Sleep Quality [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.
Mental Health [Baseline,3months,6months after randomization]: Measured using the Center for Epidemiologic Studies Depression Scale-20 (CESD-20), a self-administered questionnaire assessing depressive symptoms.
QoL [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.
Fall and emergency [Baseline,3months,6months after randomization]: Number of falls and emergency visit reported using an investigator-developed questionnaire.
Anxiety [Baseline,3months,6months after randomization]: Measured using the Generalized Anxiety Disorder-7 (GAD-7), a self-administered questionnaire assessing anxiety symptoms.

+Eligibility

Sex: All, ages: 55 Years to any

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

+Locations (1)

Facility	City	Country	Status
Yunlin HI-HOPE Community Hub	Douliu	Taiwan	Recruiting

+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