Artificial organs · 2025
Comparative Urodynamic Study in Cadaver of Urethral Pressure Profilometry Between the Artificial Urinary Sphincter UroActive and the AMS800.
СтатьяСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Beaugerie Aurélien, Tokarski Elliot, Denormandie Anne, Cotte Juliette, Tran Stéphanie, Chartier-Kastler Emmanuel, Mozer Pierre
Аннотация
INTRODUCTION AND OBJECTIVE: The artificial urinary sphincter (AUS) is currently the gold standard treatment for stress urinary incontinence in men, and it's also a treatment option for women in Europe. UroActive is a new electronic device that offers remotely adjustable settings, including device pressure. This study aims to compare the range of Maximal Urethral Closure Pressures (MUCPs) covered by UroActive with those covered by the current AMS800 in male and female cadavers.
METHODS: Six cadavers (3 males and 3 females) were implanted with an occlusive cuff (OC) positioned around the bulbar urethra in men and around the bladder neck in women. A MUCP measurement was performed for each of the 3 different AMS800 Pressure-Regulating Balloons (PRBs): 51-60, 61-70, and 71-80 cmH2O, that were successively connected to the OC. The AMS800 PRB was then replaced by the UroActive Control Unit (CU), and MUCP measurements were performed at set pressures from 10 to 150 cmH2O.
RESULTS: UroActive device remained fully functional (wireless communication, calibration) throughout the study period. UroActive CU achieved MUCPs values that encompassed the entire range observed with the 3 different AMS800 PRBs. A strong positive correlation between set device pressures sent to UroActive CU and MUCPs was noted in both males (r2 = 0.984) and females (r2 = 0.948).
CONCLUSION: The findings suggest that UroActive provides a wide adjustable range of urethral closure pressures, potentially offering an alternative to AMS800 for managing stress urinary incontinence in both men and women. Further clinical studies are necessary to confirm its safety and effectiveness in patients.
METHODS: Six cadavers (3 males and 3 females) were implanted with an occlusive cuff (OC) positioned around the bulbar urethra in men and around the bladder neck in women. A MUCP measurement was performed for each of the 3 different AMS800 Pressure-Regulating Balloons (PRBs): 51-60, 61-70, and 71-80 cmH2O, that were successively connected to the OC. The AMS800 PRB was then replaced by the UroActive Control Unit (CU), and MUCP measurements were performed at set pressures from 10 to 150 cmH2O.
RESULTS: UroActive device remained fully functional (wireless communication, calibration) throughout the study period. UroActive CU achieved MUCPs values that encompassed the entire range observed with the 3 different AMS800 PRBs. A strong positive correlation between set device pressures sent to UroActive CU and MUCPs was noted in both males (r2 = 0.984) and females (r2 = 0.948).
CONCLUSION: The findings suggest that UroActive provides a wide adjustable range of urethral closure pressures, potentially offering an alternative to AMS800 for managing stress urinary incontinence in both men and women. Further clinical studies are necessary to confirm its safety and effectiveness in patients.