Continence Care Products / Devices / Technologies
The major complications, which lead to subsequent secondary surgeries after Artificial Urinary Sphincter (AUS) are infection, cuff erosion or urethral atrophy. In several studies the temporal trend of AUS erosions demonstrates a peak in the first year after implantation, this might be linked to high occlusion pressure (1,2).
The aim of this trial is to determine the safety and efficacy of a novel AUS after a follow up of more than 12 months.
VICTO is a single unit pre-connected adjustable device with an occluding cuff (OC). This video shows initial preparation and measurement of the urethra as well as filling the implant. The filling procedure is performed by inserting the needle into the port and fill the system with 13 ml of saline solution, in case of VICTO plus the initial filling is 20 ml.
The pressure regulating balloon is placed intraperitoneally and in case of VICTO plus the stress balloon will be placed under the fascia. After passing the cuff through a subcutaneous channel form the abdominal incision to the perineum, the cuff will be placed around the urethra. Finally, the video shows the placement of the pump in the scrotum as well as closure of the perineal and abdominal incisions.
from 12/2016 and 2/2019 the device was indicated in 60 patients with stress urinary incontinence. We included the data from 51 patients with less than 3 previous incontinence surgeries (VICTO n=22, VICTO plus n=29) with a mean follow-up time of 14.1 months (median= 13.7). In all 51 cases the device was easily implanted without any intraoperative complications. The pad per day usage improved from 6.2 (±3.3) to 1.4 (±1) and the continence rate (max. 1 p/d) was 58.8%. In average there were 1.7 (median=2) adjustments needed to provide continence and the overall satisfaction was 86.4%. No revisions have been recorded due to mechanical failure, infection, erosion or atrophy. In 5 cases we have done optimizing surgeries according to our learning curve to improve the results (n=2 smaller cuff because of persistent incontinence, n=3 pump reposition).
the device provides adjustability in regulating pressure in situ. In this cohort, we achieved a continence rate of 59% and there have been no revisions due to mechanical failure, infection, erosion or atrophy. The complete absence of erosions proves the implant to be particularly safe. These results are promising and challenge prior AUS series. Adjusting the system pressure to the lowest level providing continence may reduce the long-term rate of complications, however bigger cohorts and long-term follow-ups are needed.