{"id":10596,"date":"2020-07-07T12:14:55","date_gmt":"2020-07-07T12:14:55","guid":{"rendered":"https:\/\/jurmed.ro\/medici\/?p=10596"},"modified":"2020-07-07T12:14:55","modified_gmt":"2020-07-07T12:14:55","slug":"eficacitatea-tolerabilitatea-si-acceptabilitatea-dispozitivului-medical-non-invaziv-75nc007-in-managementul-incontinentei-urinare-feminine-de-stress","status":"publish","type":"post","link":"https:\/\/jurmed.ro\/medici\/eficacitatea-tolerabilitatea-si-acceptabilitatea-dispozitivului-medical-non-invaziv-75nc007-in-managementul-incontinentei-urinare-feminine-de-stress\/","title":{"rendered":"Eficacitatea, tolerabilitatea \u0219i acceptabilitatea dispozitivului medical non invaziv 75NC007 \u00een managementul incontinen\u021bei urinare feminine de stress"},"content":{"rendered":"<p style=\"text-align: justify\"><strong>STUDIU RANDOMIZAT CONTROLAT<\/strong><\/p>\n<p style=\"text-align: justify\">Incontinen\u0163a urinar\u0103 este o problem\u0103 foarte frecvent\u0103. Prevalen\u0163a sa cre\u015fte cu v\u00e2rsta \u015fi impacteaz\u0103 negativ calitatea vie\u0163ii pacien\u0163ilor.<\/p>\n<p style=\"text-align: justify\">Dintre toate formele de incontinen\u0163\u0103 urinar\u0103, incontinen\u0163a urinar\u0103 de stres\u00a0 (IUS) este cea mai frecvent\u0103 \u00een r\u00e2ndul femeilor. Managementul incontinen\u0163ei urinare de stres poate fi chirurgical dar un num\u0103r semnificativ de paciente prefer\u0103 alternative non invazive cum ar fi dispozitive intravaginale sau pesare.<\/p>\n<p style=\"text-align: justify\"><u>Design-ul studiului<\/u><\/p>\n<p style=\"text-align: justify\">Studiul Randomizat Controlat a fost efectuat \u00een Fran\u021ba \u00een 12 clinici \u0219i centre de studii clinice comunitare \u0219i aprobat de autorit\u0103\u021bile competente franceze din domeniul s\u0103n\u0103t\u0103\u021bii.<\/p>\n<p style=\"text-align: justify\"><u>OBIECTIVUL STUDIULUI<\/u><\/p>\n<p style=\"text-align: justify\">Obiectivul studiului a fost de a determina eficacitatea, tolerabilitatea \u0219i acceptabilitatea dispozitivului medical Diveen<sup>\u00ae<\/sup> \u00een managementul IUS \u00een compara\u021bie cu un grup de control de paciente care nu au utilizat dispozitivul.<\/p>\n<p style=\"text-align: justify\"><u>METODE<\/u><\/p>\n<p style=\"text-align: justify\">Obiectivul primar a fost reducerea frecven\u021bei episoadelor de incontinen\u021b\u0103 (IEF), \u00een fiecare grup. Obiectivul secundar a fost varia\u021bia scorului Profilului de Simptome Urinare (USP), a satisfac\u021biei pacientei (Scor de la 0 la 100 ) \u0219i scorul calit\u0103\u021bii vie\u021bii prin intermediul chestionarului CONTILIFE.<\/p>\n<p style=\"text-align: justify\"><a href=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/incotinenta-urinara1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-medium wp-image-10597\" src=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/incotinenta-urinara1-300x198.jpg\" alt=\"\" width=\"300\" height=\"198\" srcset=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/incotinenta-urinara1-300x198.jpg 300w, https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/incotinenta-urinara1.jpg 365w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a>Durata studiului a fost de 6 s\u0103pt\u0103m\u00e2ni. Dup\u0103 o perioad\u0103 ini\u021bial\u0103 de 14 zile pentru determinarea referin\u021bei (liniei de baz\u0103) a IEF, participantele au fost \u00eemp\u0103r\u021bite randomizat \u00eentr-un grup de interven\u021bie \u0219i unul de control. A urmat o alt\u0103 perioad\u0103 de 14 zile \u00een care parte dintre paciente au utilizat dispozitivul (grupul de interven\u021bie) \u0219i o alt\u0103 parte nu l-au utilizat (grupul de control). \u00cen final, \u00een timpul celei de-a treia perioade de 14 zile, toate pacientele au utilizat Diveen<sup>\u00ae<\/sup> \u0219i s-a monitorizat eficacitatea \u0219i tolerabilitatea acestuia.<a href=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-2.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-10598 alignright\" src=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-2-300x150.jpg\" alt=\"\" width=\"300\" height=\"150\" srcset=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-2-300x150.jpg 300w, https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-2.jpg 626w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/p>\n<p style=\"text-align: justify\"><u>REZULTATE<\/u><\/p>\n<p style=\"text-align: justify\">Dintr-un total de 55 paciente randomizate, 41 paciente au finalizat studiul conform protocolului \u0219i au fost analizate: 24 \u00een grupul de control \u0219i 17 \u00een grupul interven\u021bional, care au utilizat dispozitivul. Analiza datelor a fost efectuat\u0103 conform protocolului \u0219i pe baza Inten\u021biei de Tratament (ITT). Cele dou\u0103 grupuri au fost comparabile la referin\u021b\u0103 \u00een materie de date demografice <em>(tabelul 1)<\/em>.<\/p>\n<p style=\"text-align: justify\"><u>REZULTATE PRIMARE<a href=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-3.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"size-medium wp-image-10599 alignright\" src=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-3-300x159.jpg\" alt=\"\" width=\"300\" height=\"159\" srcset=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-3-300x159.jpg 300w, https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-3-380x202.jpg 380w, https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2020\/07\/BBraun-3.jpg 470w\" sizes=\"auto, (max-width: 300px) 100vw, 300px\" \/><\/a><\/u><\/p>\n<p style=\"text-align: justify\">\u00cen timpul celor 2 s\u0103pt\u0103m\u00e2ni de randomizare (de ex. din ziua 14 \u00een ziua 28), rata medie de reducere a IEF a fost de 68,8 % \u00een grupul de tratament \u0219i de -8,25 % \u00een grupul de control, cu o diferen\u021b\u0103 foarte semnificativ\u0103 \u00eentre grupuri (p&lt;0,0001, <em>tabelul 2<\/em>).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>STUDIU RANDOMIZAT CONTROLAT Incontinen\u0163a urinar\u0103 este o problem\u0103 foarte frecvent\u0103. Prevalen\u0163a sa cre\u015fte cu v\u00e2rsta \u015fi impacteaz\u0103 negativ calitatea vie\u0163ii pacien\u0163ilor. Dintre toate formele de incontinen\u0163\u0103 urinar\u0103, incontinen\u0163a urinar\u0103 de [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":10597,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[429],"tags":[],"class_list":["post-10596","post","type-post","status-publish","format-standard","has-post-thumbnail","category-ginecologie"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Eficacitatea, tolerabilitatea \u0219i acceptabilitatea dispozitivului medical non invaziv 75NC007 \u00een managementul incontinen\u021bei urinare feminine de stress - Jurmed - Medici<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/jurmed.ro\/medici\/eficacitatea-tolerabilitatea-si-acceptabilitatea-dispozitivului-medical-non-invaziv-75nc007-in-managementul-incontinentei-urinare-feminine-de-stress\/\" \/>\n<meta property=\"og:locale\" content=\"ro_RO\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Eficacitatea, tolerabilitatea \u0219i acceptabilitatea dispozitivului medical non invaziv 75NC007 \u00een managementul incontinen\u021bei urinare feminine de stress - Jurmed - Medici\" \/>\n<meta property=\"og:description\" content=\"STUDIU RANDOMIZAT CONTROLAT Incontinen\u0163a urinar\u0103 este o problem\u0103 foarte frecvent\u0103. Prevalen\u0163a sa cre\u015fte cu v\u00e2rsta \u015fi impacteaz\u0103 negativ calitatea vie\u0163ii pacien\u0163ilor. 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