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a Gleason score of ≤ 3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP). RESULTSPatients were included between December 2006 and July 2008. The median (25-75th percentile) follow-up after diagnosis was 1.02 (0.6-1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of > 6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0-10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of > 6. CONCLUSIONAS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.

What ' s known on the subject? and What does the study add? Artifi cal 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 effi cacy of an artifi cial 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 fi t 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 confi rm these results and extend our investigation, for instance, to the peno-scrotal approach. however, despite good long-term outcomes, AUS implantation remains a complex procedure with a risk of complications such as erosion, infection and mechanical failure. Revision rates attributable to mechanical failure range from 8 to 45% [ 6 -8 ] . KEYWORDSSurgeon experience is a key factor for success as the learning curve is long, but < 10% of AUS implantations in the USA are performed by surgeons with experience of at least 100 procedures [ 9 ] . Most are carried out by occasional operators (1 -3 procedures/year). As the number drops from > 200 to fi ve procedures, the risk of revision increases from 13 to 24% [ 10 ] . It could, no doubt, be reduced if the technique were simplifi ed.To facilitate AUS implantation, a new device, the ZSI 375 (Zephyr Surgical Implants, Geneva, ...

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