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Septiembre 3 2009

COMITÉ NACIONAL DE EVALUACIÓN DE TECNOLOGÍA

TECNOLOGÍA INNOVADORA SOLICITADA

NEUROESTIMULADOR PLEXO SACRO PARA DISFUNCIÓN MICCIONAL E

INCONTINENCIA FECAL EN PACIENTES CON SECUELAS DE TRAUMA RAQUIMEDULAR COMPLETO (TRM).

CONCEPTOS BÁSICOS SOBRE LA TECNOLOGÍA

La neuroestimulaciòn también conocida como SARS (Sacral Anterior Rooth Stimulation) es una técnica quirúrgica implantable para la estimulación eléctrica de las raíces sacras, que controlan reflejos relacionados con las vías urinarias y rectales.

El primer paso es realizar la comprobación de la vía eferente parasimpática y el arco reflejo sacro, que puede realizarse mediante la estimulación de raíces sacras. Luego, rizotomia dorsal intradural y colocación de electrodo de estimulación, que se coloca a un estimulador programable con batería.

Se requiere un test postoperatorio temprano, para evaluar parámetros de respuesta.

La neuromodulaciòn, es la estimulación eléctrica definitiva de la raíz S3, utilizada principalmente en casos de disfunción miccional crónica causada por varias patologías.

REVISIÓN DE LA EVIDENCIA CIENTÍFICA

Se revisa evidencia científica (UP to date 2009) para el caso de neuroestimulaciòn de plexo sacro, en pacientes con secuelas neurológicas tales como incontinencia fecal e incontinencia urinaria.

Una revisión sistemática de tres estudios cruzados sugiere que puede mejorar la incontinencia en los individuos seleccionados. Los autores observaron que la estimulación percutánea transitoria de dos a tres semanas no siempre tuvo éxito en la identificación de aquellos en los que un implante permanente sería beneficiosa, lo que sugiere que se necesitan más estudios.

Ensayos controlados aleatorios comparativos entre la estimulación del nervio sacro en comparación con la terapia médica óptima (ejercicios del suelo pélvico, agentes de carga, y cambios en la dieta) en 120 pacientes con incontinencia fecal severa no mostraron significancia estadística.

Los resultados de estudios con neuromodulaciòn en incontinencia urinaria, asociada a diversas patologías, no asociadas a TRM con sección medular completa (Experiencia del Grupo Español de Neuromodulaciòn sacral – GENS) muestran una mejoría parcial y solo con un seguimiento a un año.

Hohenfellner et. All, no encontraron ningún tipo de respuesta en el tratamiento de incontinencia urinaria de urgencia en vejiga neurogènica, en pacientes con TRM con sección medular completa.

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CONCLUSIONES:

1. No hay evidencia, ni grado de recomendación del procedimiento en pacientes con secuelas neurológicas asociadas a TRM completo.

2. La evidencia muestra resultados hasta en un 70% en series de casos, para el tratamiento de otras patologías del tracto urinario con síntomas asociados, tales como disfunción miccional crónica, Síndrome de Fowler, cistitis intersticial, dolor pélvico crónica, entre otras.

3. Se considera no es pertinente autorizar protocolo quirúrgico con neuroestimulaciòn sacra, para pacientes TRM completo. Teniendo en cuenta que la evidencia está en construcción y hacen falta más estudios que avalen la tecnología como protocolo estándar de tratamiento en los casos mencionados.

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