Moxibustion for Nocturia
17 de mayo de 2026 actualizado por: Buddhist Tzu Chi General Hospital
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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Yen-Lun Kung
- Número de teléfono: +886-3-8561825
- Correo electrónico: kung818@gmail.com
Ubicaciones de estudio
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Hualien City, Taiwán
- Reclutamiento
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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Contacto:
- Yen-Lun Kung
- Correo electrónico: kung818@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
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Experimental: Moxibustión
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Apply moxibustion on acupoint
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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frequency of nocturia
Periodo de tiempo: Baseline and Week 3 and Week 6
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Baseline and Week 3 and Week 6
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nocturnal urine volume
Periodo de tiempo: Baseline and Week 3 and Week 6
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Baseline and Week 3 and Week 6
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
International Prostate Symptom Score (IPSS)
Periodo de tiempo: 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).
|
Baseline and Week 3 and Week 6
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Overactive Bladder Symptom Score (OABSS)
Periodo de tiempo: 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).
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Baseline and Week 3 and Week 6
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Quality of Life (QoL)
Periodo de tiempo: Baseline and Week 3 and Week 6
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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).
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Baseline and Week 3 and Week 6
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Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 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).
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Baseline and Week 3 and Week 6
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Abdominal muscle tension
Periodo de tiempo: Baseline and Week 3 and Week 6
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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).
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Baseline and Week 3 and Week 6
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Abdominal muscle stiffness
Periodo de tiempo: Baseline and Week 3 and Week 6
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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).
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Baseline and Week 3 and Week 6
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Abdominal muscle elasticity
Periodo de tiempo: Baseline and Week 3 and Week 6
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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).
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Baseline and Week 3 and Week 6
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2025
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
4 de marzo de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de mayo de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB114-009-A
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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