A Community-based Solution for Nocturia: Integrating Digital Technology and Behavioral Interventions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Acute urinary tract infection
Uncontrolled heart failure
Serum sodium < 130 mEq/L
Underwent urological surgery within the past three months
Trial design
Design model
Parallel
Treatments tested in this trial
Home Uroflowmetry
DeviceThis 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
BehavioralBy 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline,3months,6months after randomizationSecondary outcomes
1
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 randomization2
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 randomization3
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 randomization4
Fall and emergency
Number of falls and emergency visit reported using an investigator-developed questionnaire.
Time frame
Baseline,3months,6months after randomizationSponsors and contacts
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Source ClinicalTrials.gov