Acupoint, Moxibustion, Nocturia, Traditional Chinese Medicine
Conditions
Brief 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. 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.
Interventions
PROCEDUREMoxibustion
Apply moxibustion on acupoint
Sponsors
Buddhist Tzu Chi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 40 years or older. * Experiencing two or more nocturia episodes per night.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency of nocturia | Baseline and Week 3 and Week 6 |
| nocturnal urine volume | Baseline and Week 3 and Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Baseline and Week 3 and Week 6 | 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). |
| Overactive Bladder Symptom Score (OABSS) | Baseline and Week 3 and Week 6 | 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). |
| Quality of Life (QoL) | Baseline and Week 3 and Week 6 | 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). |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline and Week 3 and Week 6 | 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). |
| Abdominal muscle tension | Baseline and Week 3 and Week 6 | 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). |
| Abdominal muscle stiffness | Baseline and Week 3 and Week 6 | 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). |
| Abdominal muscle elasticity | Baseline and Week 3 and Week 6 | 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). |
Countries
Taiwan
Contacts
CONTACTYen-Lun Kung
Outcome results
None listed