Development of a Novel Artificial Urinary Sphincter: A Versatile Automated Device

Abstract

International audienceManagement of male severe stress urinary incontinence is currently achieved by the treatment of choice: an artificial urinary sphincter (AUS). This implantable system is designed to exert a constant circumferential force around the urethra. Although continence is totally or partially recovered in most of the patients, this method has some significant drawbacks. Besides the difficulty and discomfort of using the device, the revision rate caused by constant urethral compression, leading to urethral injuries, remains high. We present in this study a new AUS concept, with an ergonomic control, providing a lower exerted pressure on the urethral tissues and improving the continence efficiency. In fact, the implant includes a system which automatically detects circumstances involving high-intravesical pressure and adapts the occlusive pressure accordingly. The device was evaluated using isolated goat urethra, and then, in vivo. Recorded data of 16 human subjects performing different daily exercises were used to assess the detection algorithms. It is shown that occlusive pressure can be controlled by the implant with an accuracy of 1 cm H2O (98 Pa). Acceptable detection performance of seven of the eight targeted activities was observed

Artificial Urinary Sphincter: Report of the 2015 Consensus Conference

“…Indeed, the current AMS800™ device was marketed since 1983 and has never submitted to major improvements since then. A total of nine hydro‐mechanical or purely mechanical AUSs have been reportedly developed at the time of our literature review . Three of them have already been implanted and studied in humans, but none has yet been directly compared to the AMS800™.…”

“…A device, which could be easily manipulated, would allow implantation in less skillful patients who currently cannot benefit from the AMS800™. This could be accomplished by remotely controlled AUSs, as proposed recently . Furthermore, easy AUS deactivation could also improve efficacy and safety.…”

Montreal electronic artificial urinary sphincters: Our futuristic alternatives to the AMS800™

“…Finally, the possibility of adjusting cuff pressure postoperatively and in real-time would allow slight pressure increments in partially improved patients, as well as cuff deflation during the bedtime period to decrease pressure exerted on the urethra and reducing, in theory, the risk of erosion and atrophy. 19 With volume going from 30 to 50 cm 3 , they are currently the smallest devices to incorporate an electronic pumping system [10][11][12][13] with remote control 13 (Table 1), making them easy to insert through the reservoir implantation incision and easily placed at the iliac fossa in a subcutaneous pouch. As pumping systems are currently handmade, device miniaturization is limited, especially because of Y and L suture-tie connectors at the hydraulic unit level.…”

“…5,6 Influenced by this rationale, few authors have developed novel AUSs to improve the AMS800. 5,[7][8][9][10][11][12][13] Here, we present three distinct AMS800 retro-compatible pumping systems: the AUS#1, AUS#2, and AUS#3, developed recently as a collaborative work between McGill University and École polytechnique de Montréal. Our approach was to improve the AMS800 by incorporating a remotely controlled electronic pump without modifying the cuff and pressure-regulating balloon (PRB).…”

Artificial Sphincters to Manage Urinary Incontinence: A Review

“…Mechatronic hydraulic system: (d) Hached et al's device . (e) Lamraoui et al's device . EAP: (f) AUS with a cuff based on a dielectric elastomer .…”