Melendez-Munoz Joan, Braverman Meirav, Rosamilia Anna, Young Natharnia, Leitch Alison, Lee Joseph K-S
Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.
Monash Medical Centre, Moorabbin, Melbourne 3165 VIC, Australia.
Eur J Obstet Gynecol Reprod Biol. 2018 Nov;230:141-146. doi: 10.1016/j.ejogrb.2018.09.032. Epub 2018 Sep 27.
Single incision slings (SIS) were introduced in an attempt to decrease the complications associated with retropubic and transobturator slings. The TVT Abbrevo is a modification of the TVT-O with a reduced length and less immediate postoperative pain. The Miniarc SIS has been shown to be equivalent to outside-in transobturator sling, Monarc at 12 month follow-up.
To evaluate objective and subjective outcomes of MiniArc SIS and TVT Abbrevo midurethral sling (MUS) in women with stress urinary incontinence.
Female subjects who were assessed and referred for stress urinary incontinence surgery were eligible to participate in this study. Exclusion criteria included women with intrinsic sphincter deficiency previous failed midurethral or fascial sling, untreated detrusor overactivity or significant voiding dysfunction. Patients' randomisation was performed with computer-generated blocks of 4-8, with concealed allocation. Assuming an objective cure rate of 90% for TVT AbbrevoTMwith a power of 80%, a sample size of 79 in each arm was required to detect a clinical difference of 15%, using a one sided alpha of 0.05. The target recruitment number was 220 allowing for an attrition rate of 15%. Institution ethics approval (11261B) was obtained and the trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611001151921). Routine preoperative assessment was conducted for objective data, whilst patient reported outcome tools (PRO) were utilised for subjective outcomes. These include ICIQ UI SF, ICIQ OAB, IIQ7, EQ5D, PISQ12, PGIs & PGII. TVT AbbrevoTM or MiniarcTMwere performed in a standardized fashion, together with any concomitant prolapse surgery. Review was conducted at 6 weeks and at 6 and 12 months. Objective cure was defined as a negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with physical exertion. All Data was collected and outcomes were analysed statistically.
Between February 2011 and January 2016,a total of 246 women were randomized to receive MiniArc (121) or TVT Abbrevo (125). Baseline characteristics were clinically balanced in both groups. At 6 months subjective (94.4% vs 95.7% p=0.74) and Objective (92.9% vs 95.9% p=0.49) cure rates were high and not statistically different. At 12 months there were also no differences in subjective (73.6% vs 76.9% p=0.73) or objective (90.5% vs 96.0% p=0.21) cure rates. No differences were found in functional outcomes or when adjusted for potential confounding factors such as age, parity, BMI or menopausal status.
We found no significant differences in subjective and objective cure rates at 6 and 12months between MiniArc and TVT Abbrevo.
单切口吊带术（SIS）被引入以试图减少与耻骨后吊带术和经闭孔吊带术相关的并发症。TVT Abbrevo是TVT-O的一种改良术式，长度缩短且术后即刻疼痛较轻。在12个月的随访中，Miniarc SIS已被证明与由外向内经闭孔吊带术Monarc等效。
评估Miniarc SIS和TVT Abbrevo中尿道吊带术（MUS）治疗女性压力性尿失禁的客观和主观疗效。
经评估并被转诊接受压力性尿失禁手术的女性受试者有资格参与本研究。排除标准包括存在内在括约肌缺陷、既往中尿道或筋膜吊带手术失败、未治疗的逼尿肌过度活动或严重排尿功能障碍的女性。患者通过计算机生成的4 - 8人一组的区组进行随机分组，并采用隐蔽分配。假设TVT Abbrevo的客观治愈率为90%，检验效能为80%，使用单侧α = 0.05，每组需要79例样本量以检测15%的临床差异。目标招募人数为220例，允许15%的损耗率。获得了机构伦理批准（11261B），该试验在澳大利亚新西兰临床试验注册中心注册（ACTRN12611001151921）。进行常规术前评估以获取客观数据，同时使用患者报告结局工具（PRO）来评估主观结局。这些工具包括国际尿失禁咨询委员会尿失禁问卷简表（ICIQ UI SF）、国际尿失禁咨询委员会膀胱过度活动症问卷（ICIQ OAB）、IIQ7、欧洲五维度健康量表（EQ5D）、盆腔器官脱垂/尿失禁性功能问卷简表（PISQ12）、患者总体印象量表（PGIs）和患者总体印象变化量表（PGII）。TVT Abbrevo或Miniarc以标准化方式进行，同时进行任何伴随的盆底器官脱垂手术。在术后6周以及6个月和12个月进行复查。客观治愈定义为膀胱适度充盈时咳嗽压力试验阴性。主观治愈定义为体力活动时无漏尿报告。收集所有数据并对结局进行统计学分析。
在2011年2月至2016年1月期间，共有246名女性被随机分组，接受Miniarc（121例）或TVT Abbrevo（125例）治疗。两组的基线特征在临床上具有平衡性。在6个月时，主观治愈率（94.4%对95.7%，p = 0.74）和客观治愈率（92.9%对95.9%，p = 0.49）都很高且无统计学差异。在12个月时，主观治愈率（73.6%对76.9%，p = 0.73）或客观治愈率（90.5%对96.0%，p = 0.21）也没有差异。在功能结局方面或在调整年龄、产次、体重指数或绝经状态等潜在混杂因素后未发现差异。
我们发现Miniarc和TVT Abbrevo在6个月和12个月时的主观和客观治愈率没有显著差异。
