Farhat F, Švabík K, Hubka P, Martan A, Mašata J
Ceska Gynekol. 2016 Fall;81(5):324-335.
The aim of this study was to compare fixation and mobility of adjustable single-incision (Ajust) and standard transobturator midurethral sling (TVT-O) tapes based on postoperative ultrasound monitoring of the position of the tape at rest and at maximal Valsava (tape descent). The hypothesis was that fixation of SIMS Ajust is comparable to that achieved by the standard transobturator midurethral sling.
Gynecology and Obstetrics Department, GUH and 1st Charles University Prague; Gynecology and Obstetrics Department Masarykova nemocnice Ústí nad Labem.
Randomized trial, secondary analysis of ultrasound follow-up.
Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial.All patients underwent a complete urogynecological investigation before the procedure (clinical examination, urodynamics, ultrasound examination), and they filled in the ICIQ and iQol questionnaires; after surgery, to evaluate their satisfaction with the procedure, VAS and Likert scales were added.Ultrasound examination as part of each post-operative check-up was performed the first day after surgery, two weeks, three months and one year after surgery. Ultrasound measurements were taken in a supine position at rest and during maximal Valsalva. Position of the bladder neck was assessed, and the position of the tape with respect to upper and lower tape margins.
At one-year follow up no differences in subjective cure rates and objective cure rates were observed. In all checks after surgery there was no difference between the position of the tape at rest and at maximal Valsalva between the Ajust and TVT-O groups.The length of the upper and lower tape descent was similar. In TVT-O patients the mean length of upper tape margin descent increased from 8.8 mm on the first day after surgery to 10.0 mm three months after surgery; afterwards it remained stable. For Ajust patients there was virtually the same development - from 9.1 to 12 mm - and there was no further increase in the tape descent following the three-month measurement.
The quality of the tape fixation after the Ajust procedure is as good as after standard transobturator midurethral sling. We did not observe any statistically significant differences in tape position and descent, indicating that the function is similar to obturator tape, which in turn suggests the same clinical efficacy. Ultrasound monitoring should be the part of post-operative monitoring whenever novel surgical techniques are introduced.
本研究旨在通过术后超声监测静息状态及最大瓦尔萨尔瓦动作（屏气用力动作，此时吊带下降）时吊带位置，比较可调节单切口（Ajust）吊带和标准经闭孔尿道中段吊带（TVT - O）的固定情况及移动性。假设是SIMS Ajust吊带的固定效果与标准经闭孔尿道中段吊带相当。
布拉格查理大学第一附属医院妇产科及妇产科；拉贝河畔乌斯季马萨里克医院妇产科。
随机试验，超声随访的二次分析。
2010年5月至2012年5月，100例经证实存在尿动力学压力性尿失禁的女性纳入该随机试验。所有患者在手术前均接受了完整的泌尿妇科检查（临床检查、尿动力学检查、超声检查），并填写了ICIQ和iQol问卷；手术后，为评估她们对手术的满意度，增加了视觉模拟评分（VAS）和李克特量表。术后每次复查时，在术后第1天、术后2周、3个月和1年进行超声检查。超声测量在仰卧位静息状态及最大瓦尔萨尔瓦动作时进行。评估膀胱颈位置以及吊带相对于上下吊带边缘的位置。
随访1年时，主观治愈率和客观治愈率均无差异。术后所有检查中，Ajust组和TVT - O组在静息状态及最大瓦尔萨尔瓦动作时吊带位置无差异。上下吊带下降长度相似。TVT - O组患者上吊带边缘下降的平均长度从术后第1天的8.8mm增加到术后3个月的10.0mm；此后保持稳定。Ajust组患者情况基本相同——从9.1mm增加到12mm——且在3个月测量后吊带下降未进一步增加。
Ajust手术后吊带固定质量与标准经闭孔尿道中段吊带术后相当。我们未观察到吊带位置和下降存在任何统计学显著差异，这表明其功能与闭孔吊带相似，进而提示临床疗效相同。每当引入新的手术技术时，超声监测都应作为术后监测的一部分。
