An interventional study of Home Uroflowmetry and Voiding Diary in Nocturia, Sleep Disturbanc and Quality of Life, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
134 studies on the registry are indexed under Nocturia; 22 are open to participants now.
This study's planned enrollment of 50 is below the median of 71 across 108 interventional studies indexed under Nocturia.
Browse Nocturia studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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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
A general routine health eduation and follow-up
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.
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.
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.
Time frame: Baseline,3months,6months after randomization
Sleep Quality
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.
Time frame: Baseline,3months,6months after randomization
Mental Health
Measured using the Center for Epidemiologic Studies Depression Scale-20 (CESD-20), a self-administered questionnaire assessing depressive symptoms.
Time frame: Baseline,3months,6months after randomization
QoL
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.
Time frame: Baseline,3months,6months after randomization
Fall and emergency
Number of falls and emergency visit reported using an investigator-developed questionnaire.
Time frame: Baseline,3months,6months after randomization
Anxiety
Measured using the Generalized Anxiety Disorder-7 (GAD-7), a self-administered questionnaire assessing anxiety symptoms.
Time frame: Baseline,3months,6months after randomization
Plan to share: No
Started Apr 2026 (actual). Primary completion is estimated for Sep 2026, 5 months after the start.
Of 34 interventional studies with no phase under Nocturia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's planned 5 months is below that.
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