New and Emerging Artificial Urinary Sphincters for Male Stress Urinary Incontinence: From Gold Standard to Next Generation.

INTRODUCTION

For more than four decades, the AMS-800 has remained the clinical benchmark device for the treatment of male stress urinary incontinence (SUI). Although it remains the gold standard for male SUI, the AMS-800 has continued to have limitations such as suboptimal post-operative continence rates, fixed hydraulic pressure, need for manual pump use, revision burden, and risk of urethral atrophy and erosion. These limitations have influenced a new generation of AUS devices. This review summarizes commercially available, early-development, discontinued, and emerging AUS devices, with a focus on how new designs address limitations of prior devices.

METHODS

We searched PubMed, Embase, clinical trial registries, regulatory and device materials, abstracts, and manufacturer information when available.

DISCUSSION: The current device innovations include postoperative pressure adjustability, stress-responsive hydraulic systems, simplified pre-filled or pre-connected designs, electronic remote control, and nonhydraulic electromechanical compression. Several of the new and emerging devices have shown promising early data; however, most are limited to cohort data, early safety studies, or preclinical studies involving animal, cadaver, and ex vivo implementation. Importantly, direct comparisons with the AMS-800 are limited.

CONCLUSION

As these new devices continue to be created and introduced into clinical use, long-term data will be needed to determine if these design advantages actually result in consistent improvements in continence outcomes, safety, durability, usability, and revision burden.