Test apparatus and methods for performance evaluation of an artificial urinary sphincter.

We have designed, built and tested an experimental apparatus for in vitro performance testing of an artificial urinary sphincter. A simulated urinary tract delivered a simulated urine to either an excised porcine urethra or artificial urethra at a physiologically normal pressure range of 0-93 cm H2O (0-9.12 kPa) and flow rate range of 0-830 ml/min (0-1.38 x 10(-5) m3/s). Inlet urine pressure, sphincter temperatures at several locations, urine flow, differential pressure across the urethra, and linear motion of the sphincter were measured with appropriate transducers and recorded on a PC-based data acquisition system. We conclude that the simulated urinary tract is adequate for testing artificial sphincter performance and that the data acquisition system accurately measures, displays, and records the parameters which indicate system performance.