NocturiaNCT07734207
A Community-based Solution for Nocturia: Integrating Digital Technology and Behavioral Interventions
A study testing Home Uroflowmetry and Voiding Diary in people with Nocturia and Sleep Disturbanc, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Nocturia, Sleep Disturbanc, Quality of Life
- What is being tested?
- Home Uroflowmetry and Voiding Diary
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute urinary tract infection
- Uncontrolled heart failure
- Serum sodium < 130 mEq/L
- Underwent urological surgery within the past three months
- Major psychiatric or neurological disorder in an active phase, (GDS-15>5)
- Participation in other clinical trials related to nocturia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Yunlin HI-HOPE Community Hub
Douliu
Yunlin Community, 886929270729, s100755009s@gmail.com
About this study
Official title: 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.
- Conditions
- Nocturia, Sleep Disturbanc, Quality of Life
- Being tested
- Home Uroflowmetry, Voiding Diary
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home UroflowmetryDevice
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 DiaryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: Home Uroflowmetry; Behavioral: Voiding Diary |
| Control Group | No intervention | A general routine health eduation and follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline,3months,6months after randomization
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: Baseline,3months,6months after randomization
Fall and emergency
Number of falls and emergency visit reported using an investigator-developed questionnaire.
Measured: Baseline,3months,6months after randomization
Anxiety
Measured using the Generalized Anxiety Disorder-7 (GAD-7), a self-administered questionnaire assessing anxiety symptoms.
Measured: Baseline,3months,6months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start8 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734207
- Sponsor's protocol ID
- 202510038RIND
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40722581
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Community-based Solution for Nocturia: Integrating Digital Technology and Multi-strategy Interventions
- ClinicalTrials.gov ID
- NCT07734207
- Acronym / sponsor ID
- 202510038RIND
- Conditions
- Nocturia, Sleep Disturbanc, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Home Uroflowmetry, Behavioral: Voiding DiaryThe 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 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Acute urinary tract infection
- Uncontrolled heart failure
- Serum sodium < 130 mEq/L
- Underwent urological surgery within the past three months
- Major psychiatric or neurological disorder in an active phase, (GDS-15>5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home UroflowmetryThis 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. | Device | Intervention Group |
| Voiding DiaryBy 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. | Behavioural | Intervention Group |
Primary outcome
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.
5 secondary outcomes
Sleep Quality
Time frame: Baseline,3months,6months after randomization
Mental Health
Time frame: Baseline,3months,6months after randomization
QoL
Time frame: Baseline,3months,6months after randomization
Fall and emergency
Time frame: Baseline,3months,6months after randomization
Anxiety
Time frame: Baseline,3months,6months after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 40722581Tsai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Uroflowmetry and Voiding Diary in people with Nocturia and Sleep Disturbanc, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuai-Wen Wang (+886 929270729, y04186@ms1.ylh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturia Frequency (time frame: Baseline,3months,6months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.