Hypothesis / aims of study
Over the past five decades, the artificial urinary sphincter has become the gold standard for treating severe stress urinary incontinence in men. Such an implant allows the majority of patients to return to an almost normal social life.
In recent years, implants from other companies have become available with different features to meet the needs of patients.
One of the choices is the Victo® AUS by Promedon, which has several elements to improve the implant whereby a curved cuff facilitates the positioning in the best way possible and a port that at the same time facilitates the pump. Through this port, the implant can be individually adjusted to the patient's needs (closing pressure). Therefore, it is necessary to increase the filling of the implant after the healing period (6 weeks post-op). This AUS is supposed to be implanted to minimize risks due to a possible fibrotic capsule until activation.
Intra-operatively the reservoir is not filled to the required volume. During implantation the PRB is prefilled with 13ml NaCl.9% and activated 6 weeks postoperative by additional 4ml. However, an alternative PRB placement might be the extraperitoneal Retzius space (Rs). This retrospective study evaluates the safety and effectiveness of Rs-PRB placement, focusing on early complications.
Study design, materials and methods
Between 2017-23, 30 male patients with SUI, underwent AUS implantation with Rs-PRB placement. 27/30 patients had a previous radical prostatectomy; 4 additional had radiation(1-6yprior). The remaining patients had a TURP caused the SUI. Files were evaluated for complications: urethral obstruction, erosion and implant malfunction. During activation, patients were monitored for device functionality: filling ease and concerns or any other issues. Primary endpoints were safety and complication incidence. The current postoperative follow-up is 6-60months (mean 17months).
Results
The study group (n=30, aged mean 67years (57-71)) successfully underwent AUS implantation. Postop, prior to activation, no cases of urethral obstruction or erosion were observed, indicating no adverse effects from PRB positioning. Following activation, all patients achieved significant improvement in continence without difficulties in PRB filling, malfunction or inability to regulate the system’s liquid. No issues of urethral erosion occurred in the early post-activation period.
Interpretation of results
Retzius placement of the PRB of the Victo® AUS appears to be surgically feasible and easy to perform without any reported complications in early and longer postoperative follow-up.
In terms of efficacy, it appears to be a safe and alternative to the proposed intraperitoneal placement. By adjusting the filling at the time of "activation", it proved to befully functional for the patient's needs and request.