ZSI 375 artificial urinary sphincter for male urinary incontinence: a preliminary study

Study Type – Therapy (case series) Level of Evidence 4 What's known on the subject? and What does the study add? Artifical Urinary Sphincter (AUS) is the treatment of choice for moderate to severe post‐radical prostatectomy incontinence with good long‐term outcomes despite risk of complications. We report preliminary results of a new preconnected AUS (ZSI 375). Main change with the device currently available is the replacement of the abdominal reservoir by a pressure‐regulated spring in the intrascrotal pump avoiding abdominal approach. OBJECTIVE To assess retrospectively the safety and efficacy of an artificial urinary sphincter, the ZSI 375 device (Zephyr Surgical Implants, Geneva, Switzerland), in male patients with moderate‐to‐severe stress urinary incontinence after a prostate or bladder intervention. PATIENTS AND METHODS The ZSI 375 device is a one‐piece device consisting of an adjustable cuff, moulded to fit around the urethra, which is connected by a tube to a pump and a pressure‐regulating tank. It has no abdominal reservoir. Patients underwent a perineal incision for cuff placement and an inguinal incision for pump and tank scrotal placement. Complications and pads used to manage incontinence were recorded. RESULTS Between May 2009 and April 2011, 36 patients underwent ZSI 375 device placement. The median (range) follow‐up was 15.4 (6–28) months. No patient experienced bladder overactivity, chronic urinary retention, or any other adverse effect after device activation. Complications leading to device removal arose in four patients (one case of erosion, three cases of infection). Social continence (0 or 1 pad/day) was achieved in 28/36 patients (78%) at 3 months and 26/36 patients (73%) at 6 months after device activation. In 12/14 patients for a sphincter closure pressure range of 60–70 cm H 2 O, in 3/3 patients for a range of 70–80 cm H 2 O and in 2/11 for a range of 90–100 cm, H 2 O social continence was achieved only after increasing the pressure of the cuff by trans‐scrotal injection of saline. CONCLUSIONS The ZSI 375 device is safe and effective but our follow‐up may not have been long enough to identify all potential complications. Further research is needed to confirm these results and extend our investigation, for instance, to the peno‐scrotal approach.