Moxibustion for Nocturia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBuddhist Tzu Chi General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients aged 40 years or older.
Experiencing two or more nocturia episodes per night.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Moxibustion
Procedure/SurgeryApply moxibustion on acupoint
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: MoxibustionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
frequency of nocturia
Time frame
Baseline and Week 3 and Week 62
nocturnal urine volume
Time frame
Baseline and Week 3 and Week 6Secondary outcomes
1
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).
Time frame
Baseline and Week 3 and Week 62
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).
Time frame
Baseline and Week 3 and Week 63
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).
Time frame
Baseline and Week 3 and Week 64
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).
Time frame
Baseline and Week 3 and Week 6Sponsors and contacts
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Source ClinicalTrials.gov