Infla10® Pulse™Also Known As
AUS activation, sphincter activation, device initialization, AMS 800 activation, prosthetic sphincter engagement, urinary control device activation, Conti™ activation
Definition
Device activation refers to the process of turning on an artificial urinary sphincter (AUS) after the initial post-implantation healing period.1 This critical procedure involves releasing the deactivation button on the scrotal pump component of the AUS system, allowing the pressure-regulating balloon to transfer fluid to the urethral cuff, thereby establishing the device’s normal operating state.2 The activation enables the cuff to provide circumferential compression of the urethra, creating urinary continence while allowing patient-controlled voiding when needed.3 The procedure is typically performed by a urologist in an outpatient setting and represents the final step in establishing functional control of urinary incontinence through prosthetic intervention.4
Clinical Context
Device activation is primarily indicated in the management of moderate to severe stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency, most commonly following radical prostatectomy for prostate cancer.1 Patient selection criteria for artificial urinary sphincter implantation and subsequent activation include adequate manual dexterity, cognitive ability to operate the device, and motivation to manage the system.2
The timing of device activation is critical to successful outcomes. Standard protocol dictates delaying activation for 4–6 weeks post-implantation to allow for adequate healing and reduction of tissue edema.3 For patients with fragile urethras or those who have undergone radiation therapy, this waiting period may be extended to 8 weeks to minimize the risk of urethral erosion.3 During the activation procedure, the urologist locates the pump in the scrotum and presses the deactivation button to release it from the locked position, allowing the system to establish normal pressure on the urethra.4
Patient education during the activation visit is essential and includes instructions on how to operate the device for urination by squeezing the pump to deflate the cuff, allowing voiding, and then allowing the system to automatically refill within 3-5 minutes.5 Success rates for properly selected patients are high, with 70-90% reporting significant improvement in continence.1 However, potential complications that may occur after activation include mechanical failure, urethral atrophy, erosion, or infection, necessitating regular follow-up.2