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 (Transmission line) 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 at any time, with a remote control. The physician applies the minimal effective tension on the cuff using a specific interface of the remote, 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 device also allows to collect data for each individual patient. The objective of the first pilot phase of the DRY study was to demonstrate the feasibility and safety of the device implantation and activation.

The pilot phase of this interventional, prospective, non-randomized, single arm, and multicentric study (NCT04827199) 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, urethral stricture or fistula, and history of bladder tumor. 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 10 patients have achieved the 6 weeks postoperative period and 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 its device changed. At this stage, with a minimum 3-month follow up, the mean reduction in Pad weight test was of 87%. All 10 patients with activated AUS had a functional device with optimal control of the remote. Also, data have been collected on the use of the device (average use of Pee modes per day,etc).

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

The pilot phase of the trial is now complete and shows promising results. The pivotal phase is starting and aims to recruit 66 additional patients to evaluate ARTUS efficacy and tolerance in the long term.