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Studie belegt Wirksamkeit der iTind-Behandlung bei vergrößerter Prostata mehr als vier Jahre lang
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Olympus Corporation

Jul 13, 2023, 17:34 ET

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HAMBURG, Deutschland, 13. Juli 2023 /PRNewswire/ -- Die Olympus Corporation, ein weltweit agierendes Medizintechnik-Unternehmen, gab die Veröffentlichung von Studiendaten bekannt, die belegen, dass die  minimal-invasive iTind™-Behandlung  Menschen, die unter den Symptomen einer vergrößerten Prostata, auch bekannt als BPH, leiden, mehr als vier Jahre lang Linderung verschafft.

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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.

Die Daten der  Langzeitstudie  belegen, dass das iTind-Verfahren mehr als 50 Monate lang bis hin zu 79 Monate (6,6 Jahre) nach der Behandlung zu einer signifikanten und dauerhaften Linderung der BPH-bedingten Symptome des unteren Harntrakts (Lower Urinary Tract Symptoms, LUTS) und zu einer Verbesserung des   Internationalen Prostata-Symptomwerts (International Prostate Symptom Score, IPSS) und der Lebensqualität   (Quality of Life, Qol) führt.1

Aufgrund der COVID 19-Pandemie konnten die Patienten bei der Nachbehandlung nach mehr als 48 Monaten nicht persönlich für Funktionstests untersucht werden. Daher wurde das Protokoll so angepasst, dass Daten zur Linderung von Langzeitsymptomen (IPSS), die Verbesserung der QoL und die Notwendigkeit einer Nachbehandlung telefonisch gesammelt werden konnten.

Zusammenfassung der langfristigen Studienergebnisse

  • Fünfzig Patienten setzten die prospektive, einarmige,   multizentrische Studie über 36 Monate nach der Behandlung hinaus fort. Die Studie analysierte die Ergebnisse für 41 der 50 Patienten über 48 Monate hinaus. Neun der 50 Patienten standen für eine Nachuntersuchung nicht mehr zur Verfügung: Fünf Patienten wurden nicht weiterverfolgt; zwei Patienten verstarben, ohne dass ein Zusammenhang mit der Platzierung des iTind-Geräts bestand. Bei zwei Patienten (36-48 Monate nach Behandlung) wurde eine chirurgische Nachbehandlung erforderlich (eine transurethrale Resektion der Prostata, eine Thulium-Laser-Enukleation der Prostata). 
  • Die Behandlung mit dem iTind-Gerät zeigte eine signifikante Linderung der Symptome mit einer IPSS-Reduktion von 45,3 % und einer IPSS-QoL-Reduktion von 45,1 % vom Ausgangswert bis zu 79 Monate nach dem Eingriff (beide P<0,0001).
  • 36 Monate nach der Nachbehandlung wurden keine späteren postoperativen Komplikationen gemeldet und keiner der Patienten benötigte zusätzliche Medikamente.
  • Die chirurgische Nachbehandlungsrate nach 36 Monaten lag bei 4 %, und die kumulative gesamte Nachbehandlungsrate von Beginn an bis zu 79 Monaten betrug 11,1 %.

Die Studie wurde von Medi-Tate finanziert, einer hundertprozentigen Tochtergesellschaft von Olympus Corporation.

Lesen Sie hier bitte die vollständige Pressemitteilung:  www.olympus-europa.com

Informationen zu Olympus 

Seit mehr als 100 Jahren leistet Olympus seinen Beitrag zur Gesellschaft durch Fertigung von Produkten, die seinen Kunden auf der ganzen Welt optimale Ergebnisse bringen sollen. Weitere Informationen erhalten Sie auf der Webseite  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 [published online ahead of print, 2023 Jun 23]. Minerva Urol Nephrol. 2023; 10.23736/S2724-6051.23.05322-3. doi: 10.23736/S2724-6051.23.05322-3 

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