A novel device for endoscopy-guided bladder catheterization outside of the operating theatre: early clinical...

About 5-8% of bladder catheterizations are associated with difficulties. In such cases, the specialist is required to either perform suprapubic catheterization or catheter insertion under visual control in the operating theatre. Currently, a trial is assessing the efficacy, effectiveness and safety of Visus MG (a system for supervised safe bladder catheterization) in complex catheterizations after failed initial catheterization. To evaluate the rate of successful bladder catheterization, the complications rate and the ability to diagnose urethral pathologies with Visus MG in patients after failed primary catheterization, a prospective one-arm pilot study was initiated, including male patients with failed catheterization with a Foley catheter. A second catheterization was performed using the Visus MG (comprising a 20 Ch urethral catheter with an end hole at the tip, an optical part placed in a sheath, and an analogue to digital signal conversion unit connected to an image output device). The study evaluated the rate of successful catheterization, any complications that arose during catheterization, and the ability to diagnose urethral pathologies using Visus MG. 91 males were included. Catheterization was successful in 88 (96.7%) out of the 91 cases. In three cases (3.3%), the procedure was unsuccessful due to significant changes in the urethral mucosa following previous catheterization. There were no complications either during the Visus MG catheterization or in the immediate post-manipulation period. Bladder catheterization using Visus MG was successful in 96.7% of cases and showed no complications indicating that it is highly effective and safe to use in the event of previous unsuccessful catheterization, however, more prospective comparative trials are needed for relative effectiveness assessment. The advantages of this approach include portability, the ability to visualize the urethra, and the absence of any training requirements.