Neurogenic Bladder and Quality of Life in Patients With Stroke
27 de agosto de 2019 actualizado por: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
The Effects of Stroke Related Neurogenic Bladder on The Quality of Life: A Study of Turkish Population
This study investigated effects of the neurogenic bladder on the quality of life in stroke survivors.
Patients were divided into two groups: the First group consisted of patients with neurogenic bladder and the Second group consisted of patients without neurogenic bladder.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Neurogenic bladder after stroke is a commonly encountered medical condition which slows down the recovery process and exacerbates the functional status of the patient. The neurogenic bladder may possibly affect the quality of life of patients with stroke.
Objectives: The aim of this study is to investigate the relationship between the quality of life and the neurogenic bladder in Turkish stroke survivors.
Methods: 71 patients with stroke were included in the study. Patients were divided into two groups: the First group consisted of patients with neurogenic bladder and the Second group consisted of patients without neurogenic bladder. Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires were applied to both groups for clinical evaluations.
Tipo de estudio
De observación
Inscripción (Actual)
71
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.
Ubicaciones de estudio
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Istanbul, Pavo, 34186
- Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
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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
30 años a 88 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Stroke patients who were hospitalised to Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.
Descripción
Inclusion Criteria:
- Hemorrhagic or ischemic stroke
- No previous stroke history
- Disease duration > 6 months
Exclusion Criteria:
- Patients with different stroke etiologies other than cerebrovascular events (such as traumatic and tumoral pathologies)
- Previous multiple stroke history
- Pre-stroke urinary complaints
- Previous urogenital surgery history
- Spinal Cord Injury (SCI)
- Prostate volume of > 35ml documented with urinary ultrasonography
- Bladder outlet obstruction
- Poorly controlled Diabetes Mellitus (DM)
- Concomitant neurological diseases such as Multiple Sclerosis and Parkinson's Disease
- Anticholinergic, alpha agonist-antagonist drug use
- Sensory and global aphasia
- Severe communication impairment
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Case group
Case group reported urinary complaints
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Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
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Control group
Control group did not have any urinary complaints.
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Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Short Form-36 (SF-36)
Periodo de tiempo: 15 minutes
|
Short Form-36 (SF-36) was used to evaluate the quality of life of the patients.
The form consists of 36 items, which measure 8 dimensions.
These include (1) Physical function, (2) Social function, (3) Pain, (4) Energy/vitality, (5) Role limitation due to emotional problems , (6) Role limitation due to physical health problems, (7) Mental health and (8) General perception of health.
Each subscale is evaluated between 0-100 points.
A higher score indicates the better health.
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15 minutes
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beck Depression Inventory
Periodo de tiempo: 15 minutes
|
Beck Depression Inventory was used to assess depressive signs.
The scale consists of 21 items and the items are ordered from mild to severe.
Evaluation is performed in a range of 0-63 points.
The lower score indicates the better psychological profile.
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15 minutes
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Mini Mental Test (MMT)
Periodo de tiempo: 15 minutes
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Mini Mental Test (MMT) was used to evaluate the extent of cognitive impairment.
MMT is divided into 5 main categories: orientation (10 points), memory (3 points), attention and calculation (5 points), recalling (3 points) and language (9 points).
Total points is 30.
Total score between 0-9 points is considered as severe cognitive impairment.
Total score between 10-19 points is considered as moderate cognitive impairment.
Total score between 20-23 points is considered as mild cognitive impairment.
Total score between 24-30 points is considered as normal.
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15 minutes
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Brunnstrom scale
Periodo de tiempo: 15 minute
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Brunnstrom scale is used to evaluate separately upper extremity, lower extremity or hand functions.
Six stages are defined.
Stage 1: No active movement, Stage 2: Mild spasticity, weak flexor-extensor synergy patterns, Stage 3: Marked spasticity, synergy patterns are evident, Stage 4: Some isolated movements other than synergy patterns can be seen, Stage 5: Decreased spasticity, most muscle activities are isolated, Stage 6: Phasic and well-coordinated isolated movements are performed.
A higher point indicates the better status.
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15 minute
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Functional Ambulation Category
Periodo de tiempo: 15 minute
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Functional Ambulation Category (FAC) was used to evaluate the functional status.
FAC assesses human support for ambulation rather than assistive devices.
FAC 0: nonfunctional ambulation, FAC 1: Ambulator- dependent for physical assistance level II FAC 2: Ambulator- dependent for physical assistance level I, FAC 3: Ambulator-dependent for supervision FAC 4: Ambulator-independent level surfaces only FAC 5: Ambulator-independent.
A higher score indicates the better status.
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15 minute
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Barthel Index (BI)
Periodo de tiempo: 15 minute
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Barthel Index (BI) evaluates functional independence in term of daily living activity.
Total score is 100 points.
A higher point indicates better functional status.
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15 minute
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Silla de estudio: Kadriye Önes, Prof, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Milsom I, Kaplan SA, Coyne KS, Sexton CC, Kopp ZS. Effect of bothersome overactive bladder symptoms on health-related quality of life, anxiety, depression, and treatment seeking in the United States: results from EpiLUTS. Urology. 2012 Jul;80(1):90-6. doi: 10.1016/j.urology.2012.04.004.
- Panfili Z, Metcalf M, Griebling TL. Contemporary Evaluation and Treatment of Poststroke Lower Urinary Tract Dysfunction. Urol Clin North Am. 2017 Aug;44(3):403-414. doi: 10.1016/j.ucl.2017.04.007.
- Kim KJ, Heo M, Chun IA, Jun HJ; PhDc; Lee JS, Jegal H, Yang YS. The relationship between stroke and quality of life in Korean adults: based on the 2010 Korean community health survey. J Phys Ther Sci. 2015 Jan;27(1):309-12. doi: 10.1589/jpts.27.309. Epub 2015 Jan 9.
- Best KL, Ethans K, Craven BC, Noreau L, Hitzig SL. Identifying and classifying quality of life tools for neurogenic bladder function after spinal cord injury: A systematic review. J Spinal Cord Med. 2017 Sep;40(5):505-529. doi: 10.1080/10790268.2016.1226700. Epub 2016 Oct 13.
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)
15 de enero de 2015
Finalización primaria (Actual)
15 de diciembre de 2015
Finalización del estudio (Actual)
15 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
23 de agosto de 2019
Primero enviado que cumplió con los criterios de control de calidad
27 de agosto de 2019
Publicado por primera vez (Actual)
28 de agosto de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
27 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades urológicas
- Enfermedades de la vejiga urinaria
- Manifestaciones neurológicas
- Carrera
- Vejiga Urinaria Neurogénica
Otros números de identificación del estudio
- TURKEYPMR
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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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