Bristol Urological Institute, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Health Services Research Unit (HSRU), University of Aberdeen, Aberdeen, UK.
Eur Urol. 2021 Jun;79(6):812-823. doi: 10.1016/j.eururo.2021.01.024. Epub 2021 Feb 4.
Stress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.
To compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.
DESIGN, SETTING, AND PARTICIPANTS: A noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries.
Participants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group.
The primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery.
A total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} -11.6 to 4.6], p = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS.
Using a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS.
Urinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.
根治性前列腺切除术后常发生压力性尿失禁（SUI），且即使采用保守治疗也可能持续存在。吊带术是一种新兴的治疗持续性 SUI 的手术方法，但缺乏与已确立的人工尿道括约肌（AUS）的随机对照试验（RCT）比较。
比较前列腺手术后出现烦扰性尿动力学 SUI 男性的手术结果。
设计、设置和参与者：在 27 家英国中心进行了一项有烦扰性尿动力学 SUI 的男性非劣效性 RCT。由于手术原因，无法进行盲法。
参与者被随机分配（1:1）至男性经闭孔吊带（n=190）或 AUS（n=190）组。
主要结局是在随机分组后 12 个月时通过邮寄问卷从患者报告的 SUI 获得，该问卷使用国际尿失禁咨询委员会尿失禁问卷-短表（ICIQ-UI SF）中的两个项目的复合结果进行评估。非劣效性边界为 15%，这被认为是可接受的较低有效性，以换取减少不良事件（AE）和更简单的手术，用于吊带术。次要结局为手术和术后细节、患者报告的测量结果以及 12 个月时的 AE。
共纳入 380 名参与者。在随机分组后 12 个月时，男性吊带组的尿失禁率为 134/154（87.0%），而 AUS 组为 133/158（84.2%）（差异为 3.6%[95%置信区间{CI} -11.6 至 4.6]，p=0.003），表明非劣效性。尿失禁症状（ICIQ-UI SF）从基线时的 16.1 和 16.4 分别降至男性吊带组和 AUS 组的 8.7 和 7.5（平均差异 1.4[95%CI 0.2-2.6]，p=0.02）。严重不良事件（SAE）较少：男性吊带组和 AUS 组分别为 n=6 和 n=13（一名男性有三个 SAE）。两组的生活质量评分均有所提高，且患者满意度均较高。所有其他显示出统计学显著差异的次要结局均有利于 AUS。
采用严格的定义，尿失禁发生率仍然较高，男性吊带和 AUS 之间没有证据表明存在差异。两组的症状和生活质量均显著改善，且大多数男性对两种手术均满意。总体而言，次要和事后分析均有利于 AUS。
前列腺切除术后的尿失禁对男性的生活质量有很大影响。MASTER 研究表明，如果需要手术，两种手术方案都能减少症状并提高满意度，尽管大多数男性并未完全治愈。然而，大多数其他结果表明，接受人工尿道括约肌的男性比接受吊带术的男性具有更好的结局。
