Biocarbon ureterostomy device for urinary diversion. Multicenter clinical trial.
The bioCarbon ureterostomy device is a stomal prosthesis for upper tract urinary diversion that has had preliminary successes in animal and human trials in Europe and Peru. Implantation of a pure carbon stomal prosthesis offers the potential advantages of high biocompatibility, lack of encrustation, and elimination of stomal stenosis which is frequently associated with cutaneous ureterostomy. Nine bioCarbon ureterostomy devices were implanted from August, 1984 through July, 1985. Although successful implantation was achieved in 2 patients, the complication rate was high. The bioCarbon ureterostomy device has potential as an alternative form of urinary diversion. However, significant problems need to be remedied before it can be recommended for routine clinical application.