两种术式治疗女性压力性尿失禁效果和安全性的随机对照研究

Curative efficacy and safety of 2 surgical approaches in management of female stress urinary incontinence: a prospective randomized controlled trial

目的通过与改良的经闭孔阴道无张力尿道中段悬吊术(modified tension-free vaginal tape-obturator,TVT-Abbrevo)对比,研究可调节单切口微小吊带(adjustable single-incision sling,TVTAjust)治疗女性压力性尿失禁的疗效和安全性。方法筛选2015年3月至2016年7月在我院泌尿外科明确诊断为压力性尿失禁的女性患者60例,年龄(50.5±7.6)岁,体质量指数(24.9±3.3),按随机数字表法分为TVT-Abbrevo组和TVT-Ajust组(n=30)。术前评估患者年龄、体质量指数、分娩次数、最大尿流率、腹压漏尿点压等一般情况;对比分析手术时间、术中出血量、是否合并有并发症、术后疼痛、主客观治愈率、生活质量等指标。结果 TVT-Ajust组术中出血量显著少于TVT-Abbrevo组(P<0.05);术后排尿困难有4例,每组各有2例,其中TVT-Ajust组合并有1例阴道吊带腐蚀;TVT-Ajust组术后4周疼痛程度显著小于TVT-Abbrevo组(P<0.05);TVT-Abbrevo组与TVT-Ajust组术后主观治愈率和客观治愈率差异无统计学意义(P>0.05);2组术后患者生活质量较前均有明显提升(P<0.05);2种手术方式均不能显著改善急迫性尿失禁症状。结论 TVT-Ajust治疗女性压力性尿失禁是安全、有效的,与TVT-Abbrevo相比,术中出血量小、术后疼痛程度及术后中重度疼痛发生率明显减小、术后恢复快,但长期疗效需进一步观察。

Objective To compare the effectiveness and complications of adjustable single-incision sling （TVTAjust） and modified tension-free vaginal tape-obturator （TVT-Abbrevo）for the treatment of female stress urinary incontinence（SUI）. MethodsA total of 60 female patients with SUI admitted in our institute from March 2015 to July 2016 were enrolled in this study, and then randomly assigned into TVT-Abbrevo and TVT-Ajust groups （n=30 for each group）.The patients were at an average age of 50.5±7.6 years and had a mean body mass index（BMI） of 24.9±3.3. Their age, BMI, parity, maximum flow rate, and abdominal leak point pressure （ALPP） were evaluated before operation. Operation time, intraoperative bleeding volume, operation-related complications, postoperative pain, objective and subjective cure rates, and quality of life were compared between the 2 groups. ResultsThe intraoperative bleeding volume was significantly less in the TVT-Ajust group than the TVT-Abbrevo （P〈0.05）. There were 4 cases of postoperative dysuria, with each group having 2 cases, and vaginal sling corrosion was found in 1 case from the TVT-Ajust group. The patients of TVTAjust group experienced obviously milder postoperative pain than those of the TVT-Abbrevo group at 4 weeks after surgery（P〈0.05）. There were no notable differences in objective and subjective cure rates between the 2 groups（P〉0.05）. The quality of life was obviously improved in all the 60 patients after surgery （P〈005）. However, both surgical approaches could not significantly improve the symptoms of urge incontinence. ConclusionTVT-Ajust procedure is safe and effective in treatment of female SUI. Compared with TVTAbbrevo, it has less amount of intraoperative bleeding, milder postoperative pain, reduced incidence of postoperative moderate to severe pain, and faster postoperative recovery. But long-term outcomes need to be further observed.