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

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.

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

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.

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.