Brennand Erin A, Chai Julia, Cummings Shannon, Huang Beili, Hughes Taylor, Edwards Allison, Ramirez Alison Carter
Department of Obstetrics & Gynecology, University of Calgary, North Tower, Foothills Medical Center, 1441 - 29 Street NW, Calgary, AB, T2N 4J8, Canada.
Department of Community Health Sciences, University of Calgary, Calgary, Canada.
Int Urogynecol J. 2025 Feb;36(2):279-287. doi: 10.1007/s00192-024-05916-y. Epub 2024 Oct 1.
The objective was to determine if mid-urethral sling (MUS) tensioning with a Mayo Scissor as a sub-urethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in differences in patient-reported outcomes and rates of repeat surgery over a 5-year follow-up.
Follow-up 5 years after a randomized clinical trial, utilizing primary data collection linked to administrative health data, was carried out to create a longitudinal cohort. The primary outcome was participant-reported bothersome SUI symptoms, as defined by the Urogenital Distress Inventory (UDI-6) questionnaire. Secondary outcomes included participant-reported bothersome overactive bladder (OAB) scores, median scores of three validated urinary symptom questionnaires, and rates of subsequent surgery determined through patient report and administrative data.
Two hundred and sixty (81.8%) of the original study participants provided participant-reported data at 5 years. Administrative data linkage was completed for all of the original participants (n = 318). Demographic characteristics remained similar in the two groups at the 5-year follow-up mark. No differences existed in the primary outcome of reported bothersome SUI symptoms (30.8% Scissors vs 26.8% Babcock, p = 0.559), proportion of participants with bothersome OAB, the median scores of three validated bladder questionnaires, or in rates and cumulative incidence of recurrent MUS surgery or surgical revision of mesh-related complications.
Both the Scissor and Babcock tensioning techniques provided comparable outcomes at 5 years post-MUS surgery. The information from this study allows surgeons to better decide which technique to adopt in their practice, providing confidence in longer-term cure and safety.
目的是确定在5年随访期内,与使用巴布科克钳将一段吊带置于尿道下方相比,使用梅奥剪作为尿道下间隔物对中段尿道吊带(MUS)进行张紧,在患者报告的结局和再次手术率方面是否存在差异。
在一项随机临床试验5年后进行随访,利用与行政健康数据相关的原始数据收集来创建一个纵向队列。主要结局是参与者报告的令人烦恼的压力性尿失禁(SUI)症状,由泌尿生殖系统困扰量表(UDI-6)问卷定义。次要结局包括参与者报告的令人烦恼的膀胱过度活动症(OAB)评分、三份经过验证的泌尿症状问卷的中位数评分,以及通过患者报告和行政数据确定的后续手术率。
260名(81.8%)原始研究参与者在5年时提供了参与者报告的数据。所有原始参与者(n = 318)均完成了行政数据关联。在5年随访时,两组的人口统计学特征仍然相似。在报告的令人烦恼的SUI症状这一主要结局方面(梅奥剪组为30.8%,巴布科克钳组为26.8%,p = 0.559)、有令人烦恼的OAB的参与者比例、三份经过验证的膀胱问卷的中位数评分,或复发性MUS手术率及与网片相关并发症的手术修复率和累积发生率方面,均不存在差异。
梅奥剪和巴布科克钳张紧技术在MUS手术后5年时提供了相似的结局。本研究的信息使外科医生能够更好地决定在其临床实践中采用哪种技术,从而对长期治愈和安全性充满信心。