Kretschmer Alexander, Hüsch Tanja, Thomsen Frauke, Kronlachner Dominik, Pottek Tobias, Obaje Alice, Anding Ralf, Rose Achim, Olianas Roberto, Friedl Alexander, Hübner Wilhelm, Homberg Roland, Pfitzenmaier Jesco, Grein Ulrich, Queissert Fabian, Naumann Carsten M, Schweiger Josef, Wotzka Carola, Nyarangi-Dix Joanne N, Hofmann Torben, Buchner Alexander, Haferkamp Axel, Bauer Ricarda M
Department of Urology, Ludwig-Maximilians-University, Campus Großhadern, Marchioninistrasse 15, 81377, Munich, Germany.
Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.
World J Urol. 2016 Oct;34(10):1457-63. doi: 10.1007/s00345-016-1787-5. Epub 2016 Feb 25.
To analyze efficacy and safety for the ZSI375 artificial urinary sphincter in a multicenter case series.
Thirteen male patients with stress urinary incontinence underwent implantation of a ZSI375 artificial urinary sphincter device between 2010 and 2012 in three international continence reference centers. Perioperative characteristics and postoperative complications were analyzed using the Clavien-Dindo scale. Re-hospitalization and explantation rates, and functional outcome were assessed. Inner-group and between-group differences were analyzed using Wilcoxon, Mann-Whitney U, and Fisher's exact test whenever indicated. Kaplan-Meier analysis was performed to assess device survival. A p value below 0.05 was considered statistically significant.
There were no intraoperative complications. Median follow-up was 13.5 months. In this period, four device defects (30.8 %) could be observed, being the main cause for device explantation, followed by device infection (15.4 %), non-resolvable pain (7.7 %), and urethral erosion (7.7 %). There were no Clavien IV or Clavien V complications. Overall explantation rate was 61.5 %. Mean time-to-explantation was 279 ± 308 days. There was no significant influence of previous irradiation and previous invasive incontinence therapy (p = 0.587 and p = 0.685, respectively). Mean daily pad usage decreased from 5.8 ± 1.5 to 2.4 ± 2.1 (p = 0.066). One patient (7.7 %) did not use any pads. Social continence (0-1 pads) was achieved in 15.4 % of the patients.
This is the most current study that is investigating the outcome after ZSI375 implantation in a multicenter case series. Based on our results, explantation rates after ZSI375 implantation are high and efficacy rates seem lower than previously described. Addressing this high failure rate, the system has undergone a two-step modification in the meantime.
在一个多中心病例系列中分析ZSI375人工尿道括约肌的疗效和安全性。
2010年至2012年期间，13例压力性尿失禁男性患者在三个国际尿失禁参考中心接受了ZSI375人工尿道括约肌装置植入。使用Clavien-Dindo量表分析围手术期特征和术后并发症。评估再入院率、取出率和功能结局。必要时使用Wilcoxon、Mann-Whitney U和Fisher精确检验分析组内和组间差异。进行Kaplan-Meier分析以评估装置存活情况。p值低于0.05被认为具有统计学意义。
无术中并发症。中位随访时间为13.5个月。在此期间，可观察到4例装置缺陷（30.8%），这是装置取出的主要原因，其次是装置感染（15.4%）、无法缓解的疼痛（7.7%）和尿道侵蚀（7.7%）。无Clavien IV或Clavien V级并发症。总体取出率为61.5%。平均取出时间为279±308天。既往放疗和既往侵入性尿失禁治疗无显著影响（分别为p = 0.587和p = 0.685）。平均每日尿垫使用量从5.8±1.5降至2.4±2.1（p = 0.066）。1例患者（7.7%）不再使用任何尿垫。15.4%的患者实现了社会控尿（0 - 1个尿垫）。
这是目前在多中心病例系列中研究ZSI375植入术后结局的最新研究。基于我们的结果，ZSI375植入后的取出率较高，且有效率似乎低于先前描述的水平。为解决这一高失败率问题，该系统在此期间进行了两步改进。
