NocturiaNCT07598227
Moxibustion for Nocturia
A study testing Moxibustion in people with Nocturia and Acupoint, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nocturia, Acupoint, Moxibustion
- What is being tested?
- Moxibustion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2025to 31 Dec 2026
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 40 years or older.
- Experiencing two or more nocturia episodes per night.
Who cannot join
- Active urinary tract infection (UTI).
- Poorly controlled diabetes mellitus (defined as HbA1c > 6.5%).
- Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.
- Severe congestive heart failure (New York Heart Association [NYHA] functional class > II).
- Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).
- Pregnant women.
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
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City
Yen-Lun Kung, kung818@gmail.com
About this study
Official title: Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
Read the detailed description
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia. Using voiding diaries, the International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS), and Quality of Life (QoL) assessments, this study aimed to provide a cost-effective and clinically feasible complementary and alternative therapy. Furthermore, the TCM constitutional characteristics of nocturia patients were analyzed through the Constitution in Chinese Medicine Questionnaire (CCMQ) combined with evaluations of abdominal muscle tension.
- Conditions
- Nocturia, Acupoint, Moxibustion, Traditional Chinese Medicine
- Being tested
- Moxibustion
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionProcedure or surgery
Apply moxibustion on acupoint
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | Not described Receives: Procedure: Moxibustion |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of nocturia
Measured: Baseline and Week 3 and Week 6
nocturnal urine volume
Measured: Baseline and Week 3 and Week 6
Secondary outcomes (7)
International Prostate Symptom Score (IPSS)
Total score on the International Prostate Symptom Score (IPSS). The scale ranges from 0 to 35, where higher scores indicate more severe symptoms (worse outcome).
Measured: Baseline and Week 3 and Week 6
Overactive Bladder Symptom Score (OABSS)
Total score on the Overactive Bladder Symptom Score (OABSS). The OABSS is a four-item questionnaire assessing daytime frequency, nighttime frequency, urgency, and urgency incontinence. The total score ranges from 0 to 15, where higher scores indicate more severe overactive bladder symptoms (worse outcome).
Measured: Baseline and Week 3 and Week 6
Quality of Life (QoL)
The International Prostate Symptom Score (IPSS) Quality of Life (QoL) is a single-item questionnaire that assesses the patient's perceived satisfaction with their current urinary symptoms. Patients answer the question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" The score ranges from 0 to 6, where 0 represents "delighted" and 6 represents "terrible." A higher score indicates a poorer quality of life (worse outcome).
Measured: Baseline and Week 3 and Week 6
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire used to assess sleep quality over a one-month time interval. It consists of 19 individual items which are used to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of these seven component scores yields one global score. The global PSQI score ranges from 0 to 21, where 0 indicates no difficulty and 21 indicates severe difficulties in all areas. A higher score indicates poorer sleep quality (worse outcome).
Measured: Baseline and Week 3 and Week 6
Abdominal muscle tension
Muscle tone (tension) is measured using the MyotonPRO digital palpation device. The frequency (F) is calculated based on the oscillations of the muscle tissue after a mechanical impulse. The unit of measure is Hertz (Hz). A higher frequency indicates higher muscle tone (increased tension), which in the context of this study represents a worse outcome (abdominal tension).
Measured: Baseline and Week 3 and Week 6
Abdominal muscle stiffness
Dynamic stiffness (S) is measured using the MyotonPRO digital palpation device. Stiffness (S) represents the ability of the muscle tissue to resist an external force. The unit of measure is Newtons per meter (N/m). A higher value indicates a stiffer or more rigid muscle, representing a worse outcome (increased abdominal rigidity).
Measured: Baseline and Week 3 and Week 6
Abdominal muscle elasticity
Muscle elasticity is measured using the MyotonPRO digital palpation device. The logarithmic decrement (D) represents the muscle's ability to recover its shape after deformation (elasticity). This is a dimensionless value. A higher decrement value indicates lower elasticity and a longer recovery time, representing a worse outcome (reduced tissue elasticity).
Measured: Baseline and Week 3 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NocturiaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598227
- Sponsor's protocol ID
- IRB114-009-A
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study
- ClinicalTrials.gov ID
- NCT07598227
- Acronym / sponsor ID
- IRB114-009-A
- Conditions
- Nocturia, Acupoint, Moxibustion, Traditional Chinese Medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 May 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, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.
Detailed description
Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia. Using voiding diaries, the International Prostate Symptom Score (IPSS), the Overactive Bladder Symptom Score (OABSS), and Quality of Life (QoL) assessments, this study aimed to provide a cost-effective and clinically feasible complementary and alternative therapy. Furthermore, the TCM constitutional characteristics of nocturia patients were analyzed through the Constitution in Chinese Medicine Questionnaire (CCMQ) combined with evaluations of abdominal muscle tension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Procedure: Moxibustion |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 40 years or older.
- Experiencing two or more nocturia episodes per night.
Key exclusion criteria (6 listed)
- Active urinary tract infection (UTI).
- Poorly controlled diabetes mellitus (defined as HbA1c > 6.5%).
- Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.
- Severe congestive heart failure (New York Heart Association [NYHA] functional class > II).
- Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).
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 |
|---|---|---|
| MoxibustionApply moxibustion on acupoint | Procedure or surgery | Moxibustion |
Primary outcome
frequency of nocturia
Time frame: Baseline and Week 3 and Week 6
nocturnal urine volume
Time frame: Baseline and Week 3 and Week 6
7 secondary outcomes
International Prostate Symptom Score (IPSS)
Time frame: Baseline and Week 3 and Week 6
Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline and Week 3 and Week 6
Quality of Life (QoL)
Time frame: Baseline and Week 3 and Week 6
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and Week 3 and Week 6
Abdominal muscle tension
Time frame: Baseline and Week 3 and Week 6
Abdominal muscle stiffness
Time frame: Baseline and Week 3 and Week 6
Abdominal muscle elasticity
Time frame: Baseline and Week 3 and Week 6
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 20 May 2026.
Related trials for Nocturia
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer
Recruiting
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Benign Prostatic Hyperplasia
Not yet recruitingPhase 4
How Well and Safely Does Lemborexant Work for People Who Wake up at Night to Urinate (LENS)
Nocturia
RecruitingPhase 4
Ancillary Nocturnal Urinary Symptoms Analyses for TRIUMPH
Nocturia
Recruiting
Electroacupuncture as a Treatment for Refractory Overactive Bladder
Over Active Bladder, Urinary Incontinence (UI)
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 Moxibustion in people with Nocturia and Acupoint, run by Buddhist Tzu Chi General 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 20 May 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 Yen-Lun Kung (+886-3-8561825, kung818@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of nocturia (time frame: Baseline and Week 3 and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2026.