Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.
Department of Urology, China-Japan Friendship Hospital, Yinghuadong Road, Beijing, 100029, Chaoyang District, China.
BMC Urol. 2020 May 6;20(1):51. doi: 10.1186/s12894-020-00622-5.
To assess the current evidence on the effectiveness and safety of Contasure-Needleless (C-NDL) versus transobturator slings (TOT/TVT-O) in the management of female stress urinary incontinence (SUI).
A comprehensive literature review of articles that investigated the efficacy and safety of C-NDL and TOT/TVT-O was performed based on studies published before June 2019 and retrieved from PubMed, Embase, CNKI and the Cochrane Library. Two reviewers searched the literature, independently extracted the data and evaluated the quality of the data according to the inclusion and exclusion criteria. A meta-analysis was performed by using Review Manager 5.3 software.
Seven studies with 1188 SUI female patients without intrinsic sphincter deficiency (ISD) or mixed urinary incontinence were included. Our meta-analysis showed that the clinical efficacy of C-NDL is statistically non-inferior to that of TOT / TVT-O in terms of subjective cure rate [OR = 0.77, 95% confidence interval (CI) (0.53 to 1.10), p = 0.15] and objective cure rate [OR = 0.78, 95% CI (0.53 to 1.13), p = 0.19]. In addition, operating times were statistically shorter with C-NDL compared to TOT / TVT-O [mean difference (MD) = - 7.38, 95% CI (- 10.73 to - 4.04), p < 0.0001]. In terms of the postoperative visual analogue scale (VAS) and the incidence of postoperative pain, C-NDL has a greater advantage [MD = - 1.71, 95% CI (- 2.91 to - 0.50), p = 0.005]; [OR = 0.21, 95% CI (0.05 to 0.96), p = 0.04]. Complication rates were statistically similar between the groups, except for groin pain which was higher in TOT / TVT-O.
Our data suggest that C-NDL slings have similar short-term efficacy as TOT/TVT-O in curing SUI patients. Compared with TOT/TVT-O, C-NDL is associated with a shorter operative time, and the incidence of postoperative pain is decreased. Nevertheless, these findings should be further confirmed through large-volume, well-designed prospective randomized controlled trials (RCTs) with long-term follow-up.
评估 Contasure-Needleless(C-NDL)与经闭孔吊带(TOT/TVT-O)治疗女性压力性尿失禁(SUI)的有效性和安全性的当前证据。
根据 2019 年 6 月之前发表的研究,对 C-NDL 和 TOT/TVT-O 疗效和安全性的研究进行了全面的文献综述,并从 PubMed、Embase、CNKI 和 Cochrane Library 中检索到。两名审查员搜索文献,独立提取数据,并根据纳入和排除标准评估数据质量。使用 Review Manager 5.3 软件进行荟萃分析。
纳入了 7 项研究,共 1188 例无内括约肌缺陷(ISD)或混合性尿失禁的 SUI 女性患者。我们的荟萃分析表明,C-NDL 的临床疗效在主观治愈率方面与 TOT/TVT-O 无统计学差异[OR=0.77,95%置信区间(CI)(0.53 至 1.10),p=0.15]和客观治愈率[OR=0.78,95%CI(0.53 至 1.13),p=0.19]。此外,与 TOT/TVT-O 相比,C-NDL 的手术时间更短[均数差(MD)=-7.38,95%CI(-10.73 至-4.04),p<0.0001]。在术后视觉模拟评分(VAS)和术后疼痛发生率方面,C-NDL 具有更大的优势[MD=-1.71,95%CI(-2.91 至-0.50),p=0.005];[OR=0.21,95%CI(0.05 至 0.96),p=0.04]。除了腹股沟疼痛发生率更高外,两组的并发症发生率无统计学差异。
我们的数据表明,C-NDL 吊带在治疗 SUI 患者方面与 TOT/TVT-O 具有相似的短期疗效。与 TOT/TVT-O 相比,C-NDL 手术时间更短,术后疼痛发生率降低。然而,这些发现需要通过具有长期随访的大样本、精心设计的前瞻性随机对照试验(RCT)进一步证实。