Lee Joseph K-S, Rosamilia Anna, Dwyer Peter L, Lim Yik N, Muller Reinhold
Department of Urogynecology, Mercy Hospital for Women, Heidelberg, VIC, Australia; Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, University of Melbourne, Melbourne, VIC, Australia.
Pelvic Floor Clinic, Monash Medical Center, Moorabbin, VIC, Australia; Faculty of Medicine, Monash University, Melbourne, VIC, Australia.
Am J Obstet Gynecol. 2015 Jul;213(1):35.e1-35.e9. doi: 10.1016/j.ajog.2015.01.040. Epub 2015 Jan 28.
The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc (American Medical Systems, Minnetonka, MN) midurethral sling (MUS) in women with stress incontinence at 12 months.
A total of 225 women were randomized to receive MiniArc or Monarc. Women with intrinsic sphincter deficiency, previous MUS, or untreated detrusor overactivity were excluded. Objective cure was defined as negative cough stress test with a comfortably full bladder. Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire. Validated questionnaires, together with urodynamic and clinical cough stress test, were used to evaluate the objective and subjective outcomes following surgery. Participants and clinicians were not masked to treatment allocation. Outcomes were compared with exact binomial tests (eg, Fisher exact test for dichotomous data) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate.
There was no statistically significant difference in the subjective (92.2% vs 94.2%; P = .78; difference, 2.0%; 95% confidence interval, -2.7% to +6.7%) or objective (94.4% vs 96.7%; P = .50; difference, 2.3%; 95% confidence interval, -1.5% to +6.1%) cure rates between MiniArc and Monarc at 12 m, respectively, with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms.
MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months' follow-up in women without intrinsic sphincter deficiency.
本研究的目的是评估MiniArc和Monarc（美国美敦力公司，明尼通卡，明尼苏达州）两种经阴道无张力尿道中段吊带术（MUS）治疗压力性尿失禁女性患者12个月时的客观和主观疗效。
总共225名女性被随机分配接受MiniArc或Monarc治疗。排除存在固有括约肌缺陷、既往接受过MUS治疗或未治疗的逼尿肌过度活动的女性。客观治愈定义为膀胱适度充盈时咳嗽压力试验阴性。主观治愈定义为问卷调查中无咳嗽或运动时漏尿的报告。采用经过验证的问卷，结合尿动力学检查和临床咳嗽压力试验，评估术后的客观和主观疗效。参与者和临床医生未对治疗分配情况设盲。分类数据采用精确二项式检验（如二分数据的Fisher精确检验）进行结果比较，数值数据则根据情况采用Student t检验或Wilcoxon检验的精确版本进行比较。
在12个月时，MiniArc和Monarc的主观治愈率（分别为92.2%和94.2%；P = 0.78；差异为2.0%；95%置信区间为-2.7%至+6.7%）或客观治愈率（分别为94.4%和96.7%；P = 0.50；差异为2.3%；95%置信区间为-1.5%至+6.1%）均无统计学显著差异，且两组患者的膀胱过度活动症结局和失禁影响较基线均有显著改善。
在无固有括约肌缺陷的女性患者中，随访12个月时，MiniArc的疗效不劣于Monarc MUS的疗效。
