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Une étude prouve que le traitement de l'hypertrophie de la prostate par le dispositif iTind dure plus de quatre ans
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News provided by

Olympus Corporation

Jul 14, 2023, 11:19 ET

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HAMBOURG, Allemagne, 14 juillet 2023 /PRNewswire/ -- Olympus Corporation, société mondiale de technologie médicale, a annoncé la publication de données d'étude démontrant que le le traitement iTind™ peu invasif apporte un soulagement durable de plus de quatre ans aux personnes souffrant des symptômes d'une hypertrophie de la prostate, également connue sous le nom d'hyperplasie bénigne de la prostate (HBP).

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The iTind™ procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device remains in place for five to seven days, and upon removal, patients experience rapid and effective relief of their benign prostatic hyperplasia (BPH) symptoms.
The iTind™ procedure involves the placement of a temporarily implanted nitinol device that reshapes the prostatic urethra without burning or cutting out the prostate. The device remains in place for five to seven days, and upon removal, patients experience rapid and effective relief of their benign prostatic hyperplasia (BPH) symptoms.

Les données de l'étude à long terme démontrent que la procédure iTind entraîne une réduction significative et durable des symptômes des voies urinaires inférieures liés à l'hyperplasie bénigne de la prostate et une amélioration de l'IPSS (score international des symptômes prostatiques) et de la QoL (qualité de vie) pendant plus de 50 mois et jusqu'à 79 mois (6,6 ans) après le traitement.1

En raison de la pandémie de COVID-19, les patients ne pouvaient pas subir de tests fonctionnels lors du suivi après 48 mois. Le protocole a donc été adapté pour que les données concernant le soulagement des symptômes à long terme : l'amélioration de l'IPSS, de la qualité de vie et la nécessité d'un nouveau traitement puissent être recueillies par téléphone.

Résumé des résultats à long terme de l'étude

  • Cinquante patients ont poursuivi l'étude prospective, à bras unique et multicentrique au-delà de 36 mois après le traitement. L'étude analyse les résultats de 41 des 50 patients au-delà de 48 mois. Neuf des 50 patients n'étaient pas disponibles pour le suivi : cinq patients ont été perdus de vue ; deux patients sont décédés sans lien avec la mise en place du dispositif iTind ; et deux patients (suivi de 36 à 48 mois) ont dû subir un nouveau traitement chirurgical (une résection transurétrale de la prostate, une énucléation de la prostate au laser thulium).
  • Le traitement par le dispositif iTind a montré une amélioration significative des symptômes, avec une réduction de 45,3 % de l'IPSS et une réduction de l'IPSS-QoL de 45,1 % par rapport aux valeurs de référence jusqu'à 79 mois après l'intervention (tous deux P<0,0001)
  • Aucune complication postopératoire tardive n'a été signalée après 36 mois de suivi, et aucun patient n'a eu besoin de médicaments supplémentaires.
  • Le taux de retraitement chirurgical après 36 mois était de 4 %, et le taux cumulatif total de retraitement entre la date de référence et 79 mois était de 11,1 %.

L'étude a été financée par Medi-Tate, une filiale en propriété exclusive d'Olympus Corporation.

Pour lire l'intégralité du communiqué de presse, consultez le site : www.olympus-europa.com

À propos d'Olympus

Depuis plus de 100 ans, Olympus poursuit l'objectif de contribuer à la société en fabriquant des produits conçus dans le but de fournir des résultats optimaux à ses clients dans le monde entier. Pour plus d'informations, rendez-vous sur le site www.olympus-europa.com.

1

Amparore D, De Cillis S, Schulman C, Kadner G, Fiori C, Porpiglia F. Temporary implantable nitinol device for benign prostatic hyperplasia-related lower urinary tract symptoms : over 48-month results [publié en ligne avant la version imprimée, 23 juin 2023]. Minerva Urol Nephrol. 2023;10.23736/S2724-6051.23.05322-3. doi:10.23736/S2724-6051.23.05322-3

 

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