Rudnicki Martin, von Bothmer-Ostling Katarina, Holstad Anja, Magnusson Claes, Majida Memona, Merkel Constanze, Prien Jens, Jakobsson Ulf, Teleman Pia
Department of Obstetrics and Gynecology, Odense University Hospital, Odense, Denmark.
Department of Obstetrics and Gynecology, Halmstad Hospital, Halmstad, Sweden.
Acta Obstet Gynecol Scand. 2017 Nov;96(11):1347-1356. doi: 10.1111/aogs.13205. Epub 2017 Sep 15.
The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable single-incision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the one-year follow up.
The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust ; n = 155) or SMUS (TVT, TVT-O or TOT; n = 150) and were evaluated by stress test and bladder diary before and after surgery and symptoms related to incontinence using ICIQ-SF, PISQ-12 and PGI-S and PGI-I. Objective cure was defined as no leakage during a stress test and subjective cure defined as no leakage stated in the bladder diary or no indication of urinary leakage in the ICIQ-SF. Furthermore, mesh exposure and dyspareunia were recorded.
In total, 280 women [141 (91%) in the SIMS and 139 (94%) in the SMUS groups] participated in the one-year follow up. No difference between the groups was observed regarding objective and subjective outcomes. VAS score disclosed a lower postoperative pain perception in the SIMS group than in the SMUS group.
Ajust appears to be as efficient as SMUS regarding objective and subjective outcomes and was associated with less pain perception during the postoperative period.
本研究的主要目的是比较可调节单切口迷你吊带（SIMS）与标准中尿道吊带（SMUS）的客观和主观结果以及短期并发症发生率。次要目的是报告一年随访时的疼痛感知和并发症情况。
本研究设计为一项多中心前瞻性随机试验，纳入了来自丹麦、挪威和瑞典八个中心的女性。该试验已在ClinicalTrials.gov注册：NCT01754558。共纳入305名年龄小于60岁且确诊为压力性尿失禁的女性。所有女性被随机分为SIMS组（Ajust；n = 155）或SMUS组（TVT、TVT - O或TOT；n = 150），并在手术前后通过压力测试和膀胱日记进行评估，同时使用ICIQ - SF、PISQ - 12以及PGI - S和PGI - I评估与尿失禁相关的症状。客观治愈定义为压力测试时无漏尿，主观治愈定义为膀胱日记中无漏尿记录或ICIQ - SF中无尿漏迹象。此外，记录网片暴露和性交困难情况。
共有280名女性[SIMS组141名（91%），SMUS组139名（94%）]参与了一年随访。两组在客观和主观结果方面未观察到差异。视觉模拟评分（VAS）显示，SIMS组术后疼痛感知低于SMUS组。
在客观和主观结果方面，Ajust似乎与SMUS一样有效，且术后疼痛感知较少。
