Comparative Urodynamic Study in Cadaver of Urethral Pressure Profilometry Between the Artificial Urinary Sphincter UroActive and the AMS800.

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.