The Effect of Combined Systematized Behavioural Modification Education Program (SyBeMeP) With DDAVP in Patients With Nocturia
In patients with nocturia, combinational treatment of DDAVP and SyBeMeP might show better outcomes.
Systemic video instruction might prove to be beneficial by helping patients have better understanding on treatment and replacing healthcare personnel.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
One of main reason of nocturia is known as nocturnal polyuria. For the treatment of nocturia caused by overactive bladder, the combined therapy of anticholinergics plus behavioural modification has been established as the first line therapy. However, nocturia mainly comes from polyuria has been treated with desmopressin pharmacotherapy and the effect of behaviour modification education has not yet evaluated. Therefore, in this study, short term synergistic effect of combinational treatment of desmopressin and SyBeMeP (Systemized Behavioral Modification education Program) comparing desmopressin monotherpy will be evaluated in patients with nocturia.
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + simple instruction Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP. Patients will be randomized and assigned to each group at the ratio of 1:1. At screening visit, flowmetry and residual urine measurement, Complete Blood Count (CBC), atypical diabetes mellitus (ADM), electrolytes, urinalysis micro, urine concentration, and demographic examination will be done. Voiding diary will be distributed. At 2nd visit, patients will be randomized and each treatment will be initiated. IPSS, ICIQ-nocturia, and PPTB will be completed. Voiding diary will be distributed. At 3rd visit (2 weeks after from 2nd visit): IPSS, ICIQ-nocturia, and PPTB will be completed. Assess the treatment outcome including voiding diary analysis.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Seoul, Corea, república de, 110-744
- Seoul National University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- A patient with nocturia, who visited department of urology as outpatient
- Have not been treated with desmopressin for at least 6 months before
Exclusion Criteria:
- Sleep disorder,
- history of medication for voiding,
- diabetes insipidus,
- diabetes mellitus,
- cardiovascular disease,
- voiding difficulties (including residual urine of more than 100ml),
- small bladder capacity,
- overactive bladder,
- illiteracy,
- psychiatric disorder and having no intention to be enrolled by written agreement
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Desmopressin monotherapy
Control group: Desmopressin (Minirin Tablet 0.1-0.4mg/day)
+ simple instruction
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Combination group
Study group: Desmopressin (Minirin Tablet 0.1-0.4mg/day) + SyBeMeP * Patients will be randomized and assigned to each group at the ratio of 1:1. |
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Decrease in urinary frequency (No. of nocturia)
Periodo de tiempo: baseline, 2 week, 1 month, and 3 months
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baseline, 2 week, 1 month, and 3 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Voiding diary indices
Periodo de tiempo: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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IPSS
Periodo de tiempo: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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ICIQ-nocturia
Periodo de tiempo: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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patient's perception of bladder condition (PPTB)
Periodo de tiempo: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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patient's satisfaction on the education
Periodo de tiempo: baseline, 2 weeks, 1 month and 3 months
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baseline, 2 weeks, 1 month and 3 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Sung Yong Cho, M.D.,Ph.D., Seoul National University Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Nocturia-SBMP
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