A new artificial urinary sphincter with conditional occlusion for stress urinary incontinence: preliminary clinical results.

Abstract

To perform a preliminary clinical investigation to determine the safety and efficacy of a novel artificial urinary sphincter (AUS) with conditional occlusion for the treatment of stress urinary incontinence. Male patients with urodynamically proven stress urinary incontinence after a prostatectomy were implanted with the novel AUS. They were followed up over a period of 12 months and the device tested for efficacy by using objective measurements of urinary leakage and continence. We derived a new measure for continence called the Continence Index. We have demonstrated that the patients receiving the new AUS showed a reduction of greater than 10-fold in mean daily leakage volume from 770.6 ml to 55.1 ml. There was an overall improvement in the Continence Index from 54% to 97%. The new AUS with conditional occlusion provides good continence rates and enables adjustment of regulating pressure in situ.