Hypothesis / aims of study
Our first data of the VICTO system was presented in 2018, evaluating the data of 50 patients with a mean follow-up (FU) of 10.7 months, with the conclusion that the new adjustable artificial sphincter (AUS) was effective in treatment of stress urinary incontinence (SUI) with a continence rate of 60,5% and 13,6% complication rate. Aim of the current report is to evaluate the efficacy and safety of VICTO system after 104 cases.
Study design, materials and methods
Between 12/2016 and 12/2020, the device was indicated in 104 patients with SUI. We included the data from 96 patients (VICTO n= 61, VICTO plus n= 35) with a mean FU-time of 23.5 months (median 24.3; range 0.7-48). Patients with ≥3 prior incontinence surgeries were excluded (n=8). Between prostatic surgery and VICTO system placement, 37 patients (38,5%) had undergone other procedures for SUI (n=25; 17 Sling, 4 ProACT, 3 AUS, 1 Sling+ProACT) or bladder neck pathologies. 36 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= 88), the pad per day usage (p/d) improved from 6 (3.1) to 1.2 (1.1) and in average there were 1.7 (IQR=1.8) readjustments needed to achieve a sufficient result. 65 patients (74%) were considered as socially continent (≤1 p/d) and a reduction of more than 50% in p/d was obtained in additional 13,6% (n= 2). 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 8 cases due to urethral erosion (n=2), 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).
Interpretation of results
Despite the high number of patients with previous surgeries or irradiation (51%), an improvement of more than 50% in p/d was reported in 88%. Only 3 explantations (3,4%) were necessary due to infection or erosion, which is comparable to other AUS cohorts.