The ARTUS® Artificial Urinary Sphincter (AUS) is composed of a smooth cuff, placed around the urethra through a perineal approach, and connected with a cable to a Control Unit implanted in the abdominal wall (Figure 1). Its electromechanical action allows a fine adjustment of the tension exerted on the urethra with a remote control. The physician applies the minimal effective tension on the cuff, after activation of the device 6 weeks postoperatively. The patient may then choose different modes of adjustment, depending on his activities (Normal, Rest or Active mode). The objective of this pilot study was to demonstrate the feasibility and safety of the device implantation and activation.

The pilot phase of this prospective multicentric study intended to include 10 patients. Eligible patients were men with persistent stress urinary incontinence for at least 12 months, defined as a mean value of 3 consecutive 24-hour Pad Weight Test > 75 grams. Major non-inclusion criteria included a history of neurogenic bladder, previous AUS implantation, pelvic radiotherapy and urethral stricture. Endpoints were implantation procedure duration, adverse events and satisfactory functioning of the implant once activated 6 weeks postoperatively.

Ten patients were included in 4 investigational sites. Median [IQR] age was 71 [69-71] years old and median BMI of 27 [24-30] Kg/m2. The baseline median 24-hour Pad weight test was of 1130 [-930-1400] mL. All patients were successfully implanted. Median duration of anesthesia was of 60 [50-70] minutes, and median hospital stay of 3 [2-3] days. All patients had their device activated. After a median follow up of 5 months, we did not observe any device-related pain or discomfort. Two patients required a surgical revision. The first had a cuff re-adjustment due to insufficient tightening during initial implantation. The second experienced cuff movement constraints linked to damage to the silicone, and had his device changed. The mean reduction in Pad weight test was of 87% 3 months after activation. At the end of follow up, all 10 patients with activated AUS had a functional device with optimal control of the remote.

These preliminary results suggest that ARTUS AUS implantation is feasible and safe.