Efficacy and Safety of a New Adjustable Artificial Urinary Sphincter (AROYO (TM)) for the Treatment of Male Stress Urinary Incontinence: Relief I Study with 12 Months Follow-up
Abstract
The AMS 800TM is the gold standard for the treatment of moderate-to-severe stress urinary incontinence (SUI), especially in men after radical prostatectomy (RP) or transurethral resection of the prostate (TURP). The concept of circular compression of the urethra to restore continence has stood the test of time but, the AMS 800TM has several disadvantages.
These are, besides others: no possibility to change the intra-device pressure postoperatively unless the entire balloon is replaced in a second operation; need to connect all components of the AMS 800TM during the operation, thereby increasing the operation time significantly; difficulties to use the pump because of the small size and mobility in the tissue; difficult procedure to deactivate or activate the device; no possibilityof increasing the intra-device pressure during maneuvers with high intraabdominal pressure [1]. Thus, a new artificial urinary sphincter system was necessary to overcome these disadvantages and to provide optimal treatment for men suffering from SUI.
Consequently, the AROYOTM device has been developed. AROYOTM offers the following advantages compared to the AMS 800TM: all components are pre-connected leading to a simpler and faster implantation, possibility to incrementally increase the urethral occlusive pressure post-operatively by adding fluid to the system to further reduce urinary leakage according to the individual needs of the patient, a simplified, easier to operate ON-OFF mechanism for use only with one hand, and a secondary mechanism to temporarily increase the urethral occlusive pressure during stressful events, such as sneezing or coughing.
The aims of this pilot study were to evaluate the efficacy and safety of the new adjustable AROYOTM device for the treatment of male SUI.