MP71-04: Adjustable artificial sphincter VICTO in the treatment of urinary incontinence: early results in a cohort of high-risk cases in a prospective single center study
Introduction: Victo is an adjustable artificial urinary sphincter (AUS), consisting of three parts which are preconnected. A pressure regulating balloon, a cuff, and a pump, which includes a self-sealing port for adjustment. The objective of the present study is to test the efficiency and practicality of VICTO in the control of stress urinary incontinence (SUI) and to evaluate the short- and long-term complications. Methods: A total of 32 patients were included between 1/2020 and 4/2022, the trial is still ongoing and estimated end of the clinical trial is May 2025. 41% of the patients in this cohort has undergone prior procedures for SUI: sling n=4, ProACT n=4, AMS 800=1, 3 patients had multiple SUI surgeries. 38% of the patients had undergone secondary irradiation therapy. Additionally, 9 patients had undergone procedures for bladder neck pathologies or urethral strictures. All patients underwent artificial urethral sphincter (AUS) implant “VICTO” according to established technique. The mean age was 71,9 years, 41% of the patients had systemic arterial hypertension and 19% diabetes mellitus. 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: The reduction in number of pads compared between baseline and Follow-Up was significant (p <0,001). Cure of urinary incontinence was defined as using either 0 or 1 p/d. All the index patients in this cohort (n=7) were cured. In total 64,5% of the patients reported to be dry and were cured by definition. Additionally, 19,4% patients reported improvement of = 50 % according the PGI-I (Patients Global Impression of Improvement). Two erosions were reported over the FU-period (mean 4,6 months). One infection occurred after traumatic catheterization without deactivation of the device followed by urethral erosion, infection and explantation of the device. Both patients with erosion had previous pelvic irradiation. One explantation was reported at day 2 after implantation, the presumable cause of explantation was unrecognized intra-operative urethral injury and consequently urethral erosion and was excluded from the study. Conclusions: In this complex group with mostly high-risk patients, all men with uncomplicated SUI (no previous surgeries and no history of irradiation) were cured after device implantation. The overall treatment success was 84 % according PGI-I and 65% according to pad per day usage. Despite the above average number of patients with risk factors for failure in this cohort, the results of the current trial are consistent with the evidence in literature. SOURCE OF Funding: none
