Nocturia, Quality of Life, Sleep Disturbanc
Conditions
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.
Interventions
DEVICEHome 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.
BEHAVIORALVoiding 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
CONTACTShuai-Wen Wang
Outcome results
None listed