Ghazal Ameli, Tanja Hüsch, Wilhelm A Hübner, Peter Weibl
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引用次数: 0
Abstract
Background: Artificial urinary sphinkter (AUS) are still the gold standard for treatment of male stress urinary incontinence with good clinical outcomes and high patient's reported satisfaction rate. However, more than half of the patients with an AUS will require additional procedures, most likely revisions. To introduce a novel adjustable AUS for treatment of male stress urinary incontinence and perform a preliminary clinical investigation to determine the safety and efficacy of the device.
Methods: Men with urodynamically proven SUI following radical prostatectomy (RP), transurethral resection of prostate (TURP) and pelvic injuries were implanted with the Victo-AUS. Patients with three or more previous incontinence surgeries were excluded from the series. Patients were monitored over a mean follow up of 29 months (range, 13.7-47.9 months). The device was tested for efficacy by using objective measurements of urinary leakage and continence. We used validated questionnaires at baseline and clinical follow-ups. The key outcomes were overall improvement, patients reported satisfaction and complication rate.
Results: A total of 88 patients between December 2016 and December 2019 have been enrolled in this trial. Improvement was defined as a reduction in pad usage per day (p/d) over 50% compared to baseline. In total, 70 (88%) patients were reported to be improved. Treatment success according to the definition of 0-1 p/d was accomplished in 56 (70%) patients. Urethral erosion, infection or mechanical failure occurred in 4 (5%), 4 (5%) and 1 (1.3%) patient respectively. Explantation of the device was mandatory in 6 patients due to erosion, infection or mechanical failure.
Conclusions: In this series, a continence rate of 70% was achieved with an acceptable complication-rate. These results together with a high satisfaction rate demonstrate effectiveness and safety of the Victo system in mid-term follow-up for the treatment of male SUI.
期刊介绍:
Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance.
Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.