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人工尿失禁括约肌植入术的手术和患者报告结局:一项多中心、前瞻性、观察性研究。

Surgical and Patient Reported Outcomes of Artificial Urinary Sphincter Implantation: A Multicenter, Prospective, Observational Study.

机构信息

Department of Urology, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Urology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.

Department of Urology, Tokyo Medical and Dental University, Tokyo, Japan.

出版信息

J Urol. 2018 Jan;199(1):245-250. doi: 10.1016/j.juro.2017.08.077. Epub 2017 Aug 18.

Abstract

PURPOSE

We performed a multicenter, prospective, observational study to assess outcomes, including changes in continence status and quality of life, after artificial urinary sphincter implantation.

MATERIALS AND METHODS

Prospectively enrolled in this study were 135 patients who underwent primary AMS 800™ implantation between 2011 and 2014 at 1 of 5 institutions. Perioperative complications were categorized according to the Clavien-Dindo classification. We estimated the revision-free rate, that is the incidence of patients who did not undergo artificial urinary sphincter revision surgery. Cox regression analysis was performed to identify patient risk factors for revision surgery. The number of pads needed per day, ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form) and KHQ (King's Health Questionnaire) were used to estimate continence status and quality of life preoperatively, and 1, 3 and 12 months postoperatively.

RESULTS

The artificial urinary sphincter was implanted without major complications. The revision-free rate 1, 2 and 3 years after implantation was 94%, 88% and 81%, respectively. Diabetes mellitus and poor preoperative American Society of Anesthesiologists® physical status were significant risk factors for revision surgery. Continence status and quality of life were markedly improved after surgery. However, ICIQ-SF and some KHQ items showed slight but significant deterioration at 12 months compared with scores 1 month after surgery.

CONCLUSIONS

Artificial urinary sphincter implantation is a safe and durable procedure that substantially improves patient continence status and quality of life soon after surgery. Our results indicate that patients start to experience slight but noticeable deterioration in continence status and quality of life relatively early (within 1 year) after surgery. This finding might be helpful with appropriately counseling patients who undergo artificial urinary sphincter implantation.

摘要

目的

我们进行了一项多中心、前瞻性、观察性研究,以评估人工尿括约肌植入后的结果,包括控尿状态和生活质量的变化。

材料与方法

本研究前瞻性纳入了 2011 年至 2014 年期间在 5 家机构中的 1 家接受初次 AMS 800™植入术的 135 例患者。根据 Clavien-Dindo 分类对围手术期并发症进行分类。我们估计了无翻修率,即未行人工尿括约肌翻修手术的患者比例。采用 Cox 回归分析确定患者行翻修手术的风险因素。术前、术后 1、3 和 12 个月,使用每天所需尿垫数、ICIQ-SF(国际尿失禁咨询问卷-简短表)和 KHQ(King's Health Questionnaire)评估控尿状态和生活质量。

结果

人工尿括约肌植入术无重大并发症。术后 1、2 和 3 年的无翻修率分别为 94%、88%和 81%。糖尿病和较差的术前美国麻醉医师协会(ASA)身体状况是翻修手术的显著风险因素。术后控尿状态和生活质量显著改善。然而,与术后 1 个月相比,ICIQ-SF 和某些 KHQ 项目在 12 个月时略有但有统计学意义的恶化。

结论

人工尿括约肌植入术是一种安全且持久的方法,可显著改善患者术后的控尿状态和生活质量。我们的结果表明,患者在术后相对早期(1 年内)开始经历轻微但明显的控尿状态和生活质量恶化。这一发现可能有助于对接受人工尿括约肌植入术的患者进行适当的咨询。

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