A New Artificial Urinary Sphincter with Conditional Occlusion for Stress Urinary Incontinence: Preliminary Clinical Results
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摘要

Objectives

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.

Methods

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.

Results

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%.

Conclusions

The new AUS with conditional occlusion provides good continence rates and enables adjustment of regulating pressure in situ.

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