Amat I Tardiu Lluís, Martínez Franco Eva, Laïlla Vicens Josep Maria
Pelvic Floor Unit Obstetrics and Gynaecologic Department, Hospital Universitari Sant Joan de Déu, 08950 Esplugues de Llobregat, Barcelona, Spain.
Int Urogynecol J. 2011 Jul;22(7):827-33. doi: 10.1007/s00192-011-1380-9. Epub 2011 Mar 2.
Single-incision devices for the treatment of stress urinary incontinence (SUI) have been introduced in the last few years. We report a comparison between Obturator Tension-free vaginal tape (TVT-O) and Contasure-Needleless (C-NDL).
One hundred and fifty-eight women with primary SUI were scheduled to receive TVT-O or C-NDL and follow-up during the first year. Epidemiological information, complications, blood loss, and pain level were recorded. We also analyze stress test and quality of life.
Sixty-three (87.5%) C-NDL presented a negative stress test, compared with 54 (90%) of TVT-O (p value 0.015 for non-inferiority test). Sandvik Severity Index was 0 in 75.4% in the C-NDL group and 87.3% in the TVT-O (p < 0.015). Complication rate and degree of satisfaction were similar in both groups. Statistically, there were differences (p = 0.012) in postoperative pain in the TVT-O group.
C-NDL provides similar outcomes as TVT-O after 1-year follow-up. It is necessary that long-term data confirm our results.
过去几年中已推出用于治疗压力性尿失禁(SUI)的单切口装置。我们报告了闭孔无张力阴道吊带术(TVT - O)和Contasure - 无针装置(C - NDL)之间的比较。
158例原发性SUI女性患者计划接受TVT - O或C - NDL治疗,并在第一年进行随访。记录流行病学信息、并发症、失血量和疼痛程度。我们还分析了压力测试和生活质量。
63例(87.5%)接受C - NDL治疗的患者压力测试结果为阴性,而接受TVT - O治疗的患者中有54例(90%)(非劣效性测试的p值为0.015)。C - NDL组中75.4%的患者桑德维克严重程度指数为0,TVT - O组为87.3%(p < 0.015)。两组的并发症发生率和满意度相似。在统计学上,TVT - O组术后疼痛存在差异(p = 0.012)。
经过1年的随访,C - NDL与TVT - O的治疗效果相似。需要长期数据来证实我们的结果。