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Biocarbon ureterostomy device for urinary diversion. Multicenter clinical trial.
M Chancellor1, H B Grossman, J Konnak
1Department of Surgery, University of Michigan Medical Center, Ann Arbor.
Urology
|July 1, 1989
Summary
The bioCarbon ureterostomy device, a stomal prosthesis for urinary diversion, showed potential but had a high complication rate in early human trials. Further improvements are needed before its routine clinical use.
Area of Science:
- Urology
- Biomaterials Science
Background:
- Cutaneous ureterostomy can lead to stomal stenosis and encrustation.
- A pure carbon stomal prosthesis offers potential advantages like high biocompatibility.
Purpose of the Study:
- To evaluate the clinical application of the bioCarbon ureterostomy device.
- To assess the efficacy and complications of this novel stomal prosthesis.
Main Methods:
- Nine bioCarbon ureterostomy devices were implanted between August 1984 and July 1985.
- Clinical outcomes and complication rates were monitored.
Main Results:
- Successful implantation was achieved in 2 patients.
- A high complication rate was observed during the study period.
Conclusions:
- The bioCarbon ureterostomy device shows potential as an alternative urinary diversion method.
- Significant technical challenges must be addressed for widespread clinical adoption.