单切口Needleless无针吊带与TOT治疗女性压力性尿失禁临床疗效的比较研究

Clinical efficacy of Needleless sling technique and TOT in the treatment of female stress urinary incontinence:aproactive randomized controlled trial

目的：通过与经闭孔无张力尿道中段吊带术（TOT）的比较,评估单切口Needleless无针吊带治疗女性压力性尿失禁的疗效和安全性。方法：将2014年9月-2015年9月期间收治的压力性尿失禁患者采用信封抽取方式随机分为Needleless组和TOT组,比较两组手术时间、术中出血量、住院时间、手术治愈率、手术并发症、术后疼痛等围手术期指标及随访后手术治愈率、压力性尿失禁评分、腹股沟/大腿内侧疼痛等指标。结果：共计164例患者入组本研究,Needleless组78例,TOT组86例,两组患者术前一般资料差异无统计学意义。围手术期比较,Needleless组在手术时间、术中出血量、术后24h疼痛及住院时间方面均明显优于TOT组,差异有统计学意义（P〈0.01）。术后2周手术治愈率及围手术期并发症两组间差异无统计学意义（P〉0.05）,Needleless组在腹股沟/大腿内侧疼痛评分方面优于TOT组（P〈0.01）;术后6、12个月手术治愈率、尿垫试验及ICIQ-SF评分两组差异均无统计学意义（P〉0.05）,腹股沟疼痛发生率Needleless组低于TOT组,但差异无统计学意义（P〉0.05）。两组患者术后生活质量评分较术前均有显著提高（P〈0.01）,但两组间比较差异无统计学意义（P〉0.05）。结论：单切口Needleless无针吊带治疗女性压力性尿失禁疗效与TOT手术相当,手术简便快捷,术中出血少,恢复快,可明显降低患者术后腹股沟区疼痛,缩短住院时间,是一种简便、安全、有效的微创吊带手术。

Objective：To compare the efficacy and safety between Needleless sling technique and trans-obturator vaginal tape（TOT）in the treatment of female stress urinary incontinence.Method：From Sep.2014 to Sep.2015,consecutive subjects were enrolled in the study which were randomized by envelope technique at the time of surgery to either TOT or Needleless anti-incontinence procedure.Surgery duration,blood loss,groin pain scores,operative complications,hospital stay and operation cure parameters were recorded for each patient.The follow-up visit included cure parameters,groin pain and incontinence questionnaire-short form（ICIQ-SF）.Result：A total of 164 patients assessed for eligibility were randomized into Needleless groups（n=78）and TOT（n=86）.There was no significant difference in age,body mass index,process,parity,pad test or preoperative quality of life assessment between the two comparative study groups.In the perioperative period,statistically significant difference between the two groups was found in operating time,blood loss,groin pain scores 24 hpostoperatively and hospital stays（P〈0.01）.Two weeks follow-up,a statistically significant difference between the two groups was found in groin pain scores,but there was no significant difference between Needleless technique and TOT groups in cure rates,pad test,complications or ICIQ-SF.After one year,there was no significant difference between Needleless technique and TOT groups in cure rates,pad test,groin pain or ICIQ-SF.Both groups registered a significant improvement in quality of life（P〈0.01）.Conclusion：The single incision Needleless sling technique is a safe,effective treatment with less side effects and less complications.