Effectiveness evaluation of Contasure Needleless~ needleless used in female patients with stress urinary incontinence
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摘要: 目的 探讨Contasure Needleless®无针吊带对女性压力性尿失禁(SUI)患者的临床治疗效果。 方法 筛选并纳入2014年3月—2016年2月浙江大学明州医院和宁波妇儿医院收治的女性SUI患者148例作为研究对象。应用随机数字表法将全部患者随机分为2组,观察组行Contasure Needleless®治疗,对照组行经闭孔无张力尿道中段悬吊术(TVT-O)治疗。评价2组患者的临床治疗效果、围手术期相关指标(手术时间、术中出血量、术后24 h疼痛、住院时间,术后感染、尿潴留、血肿)、术后生活质量的改善及并发症的发生率。 结果 ①治疗效果:观察组中85.7%治愈,8.6%缓解,5.7%无效,对照组分别为89.7%、5.9%、4.4%,2组总有效率比较差异无统计学意义(P>0.05)。②围术期相关指标:观察组手术时间、术中出血量及术后24 h疼痛评分均明显优于对照组(t=21.602、6.147、3.470,P<0.05)。③术后生活质量的改善:2组患者术后ICIQ-SF、IIQ-7、UDI-6等生活质量评分指标比较差异均无统计学意义(P>0.05)。④并发症的发生率:观察组并发症总发生率为8.11%(6/74);对照组为17.57%(13/74),2组比较差异有统计学意义(χ2=4.000,P=0.045)。 结论 Contasure Needleless®无针吊带治疗我国女性SUI疗效与TVT-O相当,但其具有手术时间短、术中出血少、腹股沟区疼痛发生率低的临床优势,值得在我国各级医院推广实施。
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关键词:
- 压力性尿失禁 /
- 无针吊带 /
- ContasureNeedleless /
- 经闭孔无张力尿道中段悬吊术
Abstract: Objective To investigate the clinical efficacy of Contasure Needleless® platinum needleless sling in the treatment of female stress urinary incontinence(SUI) in women. Methods Total 148 cases women with SUI in our hospital between March,2014 and February,2016 were enrolled and randomly divided into two groups by random number table method.The observation group was treated with Contasure-Needleless system,while the control group received the tension-free vaginal tape-obturator (TVT-O).The clinical effectiveness,perioperative indicators(operating time,blood loss,postoperative pain in 24 h,length of hospital stay,postoperative infections,urinary retention and hematoma),postoperative QOL of patients and incidence of complication were compared between the two groups. Results ①The curative effect:in the observation group,85.7% of patients were cured,8.6% were PR,5.7% were NR,while in the control group were 89.7%,5.9%,4.4%,respectively.There was no significant difference in the total effective rate between the two groups(P>0.05).②perioperative indexes:the operation time,intraoperative blood loss and postoperative 24 h pain scores in the observation group were significantly better than those of the control group(t=21.602,6.147,3.470,P<0.05).③postoperative quality of life:after the operation,the difference of ICIQ-SF,IIQ-7,UDI-6 and other quality of life scoring indicators in the two groups had not statistically significant (P>0.05).④The incidence of complications:the total incidence of complications in the observation group was 8.11%(6/74),and in the control group was 17.57%(13/74),the difference between the two groups was statistically significant(χ2=4.000,P=0.045). Conclusion The curative effect of Contasure-Needleless sling for female SUI patients in China was the same as the TVT-O,with the clinical advantages of shorter operative time,less bleeding in operation and pain postoperative in the groin area,it is worthy of popularization in hospitals of our country.
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