Experience with the artificial urinary sphincter model AS800 in 148 patients

Area of Science:

• Urology
• Medical Devices
• Reconstructive Surgery

Background:

• Urinary incontinence affects a significant patient population, necessitating effective treatment options.
• Artificial urinary sphincters are a key therapeutic modality for managing severe incontinence.
• The AS800 represents an advancement in artificial urinary sphincter technology.

Purpose of the Study:

• To evaluate the efficacy and safety of the AS800 artificial urinary sphincter in patients with diverse etiologies of urinary incontinence.
• To assess the device's performance, including success rates and reasons for explantation.
• To analyze the impact of the deactivation feature on patient management.

Main Methods:

• A prospective study involving 148 patients (112 male, 36 female) implanted with the AS800 artificial urinary sphincter.
• Cuff placement evaluated at the bladder neck (78 patients) or bulbar urethra (70 patients).
• Follow-up ranged from 3 to 37 months (average 20.8 months) to assess outcomes and complications.

Main Results:

• Socially acceptable urinary control was achieved in 90% of patients with active devices.
• Sphincter removal was required in 7.4% of patients, predominantly due to infection and erosion (5.4%).
• Higher success rates were observed in patients with post-surgical incontinence (failed anti-stress operations, TURP, or prostatectomy), while higher failure rates occurred in cases secondary to pelvic fracture or exstrophy/epispadias.

Conclusions:

• The AS800 artificial urinary sphincter demonstrates high efficacy and acceptable safety profiles for treating various forms of urinary incontinence.
• The device's deactivation feature offers significant benefits for catheterization, cystoscopy, and nocturnal decompression.
• Patient selection based on etiology is crucial for optimizing outcomes with the AS800 artificial urinary sphincter.