Raw data of quality of life.

Background
Artificial Urinary Sphincter (AUS) has always been considered the gold standard for surgical treatment of male non-neurogenic Stress Urinary Incontinence (SUI). The purpose of this meta-analysis was to evaluate AUS’s effectiveness in treating male SUI, as described in the literature.
Methods
Two independent reviewers used PubMed, EMBASE, Web of Science, CNKI, WanFang Data, and VIP databases, to find the efficacy of artificial urethral sphincter in treating SUI after male prostate surgery. We excluded studies on female urinary incontinence. The main purpose of this study was to evaluate the clinical efficacy based on the degree of dry rate after AUS AMS 800™: postoperative complete dry was defined as no pad use per day. Postoperative social dry was defined as 0–1 pad per day. The secondary goal was to analyze the use of AUS AMS 800™ to improve SUI and to calculate the degree of influence by analyzing the number of pads and postoperative quality of life. And methodologic quality of the overall body of evidence was evaluated using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) guidelines.
Results
The data in this paper are mostly based on prospective or retrospective cohort studies without control groups. Fortunately, most studies have the same criteria to assess effectiveness. The pooled data of 1271 patients from 19 studies (6 prospective cohort studies, 12 retrospective cohort studies, and 1 randomized controlled trial) showed that: the number of pads used (pads/ day) after AUS was significantly reduced by about 4 (P < 0.001) and the quality of life was improved (P < 0.001).In addition, data analysis showed a high degree of heterogeneity between studies. According to the severity of baseline SUI, subgroup analysis was performed on the postoperative dry rate and social dry rate. Although heterogeneity was reduced, I2 is still above 50%, considering that heterogeneity may not be related to the severity of SUI. The random effect model was used for data analysis: the dry rate was about 52% (P < 0.001), and the social dry rate was about 82% (P < 0.001). The evidence level of GRADE of dry rate is very low, the evidence level of social dry rate and Pads use (pads/day) is Moderate, and the evidence level of Quality of life is low.
Conclusion
Although the evidence in this paper is based on descriptive studies and limited follow-up, the results show that AUS is effective in treating urinary incontinence and can improve patients’ quality of life.

背景
人工尿道括约肌（Artificial Urinary Sphincter，AUS）一直被视为男性非神经源性压力性尿失禁（Stress Urinary Incontinence，SUI）外科治疗的金标准。本荟萃分析旨在基于已发表文献，评估人工尿道括约肌治疗男性压力性尿失禁的临床疗效。

方法
两名独立评审员通过PubMed、EMBASE、Web of Science、CNKI、WanFang Data及VIP数据库，检索男性前列腺术后压力性尿失禁患者接受人工尿道括约肌治疗的疗效相关研究，排除针对女性尿失禁的研究。本研究的主要目的为基于人工尿道括约肌AMS 800™术后的控尿率评估临床疗效：术后完全控尿定义为每日无需使用尿垫，术后社交控尿定义为每日使用尿垫数量为0~1片。本研究的次要目标为分析人工尿道括约肌AMS 800™改善压力性尿失禁的效果，并通过尿垫使用数量与术后生活质量评分计算其影响程度；同时采用推荐分级、评估、制定与评价（Grading of Recommendations Assessment, Development, and Evaluation，GRADE）指南，对整体证据的方法学质量进行评价。

结果
本研究纳入的数据大多来自无对照组的前瞻性或回顾性队列研究，所幸多数研究采用了一致的疗效评估标准。对19项研究（含6项前瞻性队列研究、12项回顾性队列研究及1项随机对照试验）共计1271例患者的合并数据进行分析后显示：人工尿道括约肌术后患者每日尿垫使用量较术前显著减少约4片（P<0.001），且生活质量得到明显改善（P<0.001）。此外，数据分析显示各项研究间存在较高异质性。本研究根据基线压力性尿失禁严重程度进行亚组分析，针对术后完全控尿率与社交控尿率展开评估；尽管异质性有所降低，但I²值仍高于50%，提示异质性可能与压力性尿失禁严重程度无关。采用随机效应模型进行数据分析后结果显示：术后完全控尿率约为52%（P<0.001），社交控尿率约为82%（P<0.001）。根据GRADE分级标准，完全控尿率的证据等级为极低，社交控尿率与每日尿垫使用量的证据等级为中等，生活质量相关证据等级为低。

结论
尽管本研究纳入的证据均来自描述性研究且随访时长有限，但研究结果证实人工尿道括约肌治疗男性尿失禁安全有效，可显著改善患者的生活质量。