Introduction: To report our experiences using an adjustable artificial urinary sphincter since 2016 for male stress urinary incontinence (SUI). To evaluate the safety and efficacy in recipients of the VICTO system.
Methods: Between 12/2016 and 1/2021, the device was indicated in 110 patients with SUI. We included the data from 100 patients (VICTO n= 65, VICTO plus n= 35) with a mean FU-time of 24 months (median 25.2; range 0.8-49.5). Patients with =3 prior incontinence surgeries were excluded (n=10). Between prostatic surgery and VICTO system placement, 40 patients (40%) had undergone other procedures for SUI (n=29; 19 Sling, 4 ProACT, 5 AUS, 1 Sling+ProACT) or bladder neck pathologies. 39 had undergone secondary irradiation therapy after prostatectomy. Functional urinary outcomes were assessed according to daily pad use and a standardized questionnaire. Data were collected as part of the follow up care of these patients.
Results: After a median FU of 24 months (n=91), the pad per day usage (p/d) improved from 6 (range 2-12) to 1 (range 0-4) and in average there were 2 (IQR=1.9) readjustments needed to achieve a sufficient result. 67 patients (74%) were considered as socially continent (=1 p/d) and a reduction of more than 50% in p/d was obtained in additional 14.3% (n=13). In 10 cases we have done optimizing surgeries to improve the overall results (smaller cuff or pump reposition). However, all of these patients were within the first 30 placements and probably represent the “learning curve”.
The device had to be removed in 9 cases due to urethral erosion (n=3), infection (n=1) or insufficient incontinence recovery(n=4) and in one case a supravesical urinary diversion with ileum conduit was indicated, consequently the AUS was no longer indicated. No revisions have been recorded due to atrophy. For validation purposes, we did subgroup analysis and compared the results of the patients with previous incontinence surgeries and radiotherapy with index patients. Results in term of p/d were similar and showed no statistically relevant differences (p= .23).
Conclusions: The device provides adjustability in regulating pressure in situ. In this cohort we achieved a continence rate of 74% and the complication rate was acceptable. It has to be mentioned that 51 patients (56%) had previous surgeries or irradiation. These results are promising, however bigger cohorts and long-term follow-ups are needed.
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