Dogan Ozan, Basbug Alper, Kaya Aski Ellibes, Pulatoglu Cigdem, Yassa Murat
Department of Obstetrics and Gynecology, Health Sciences University, Sisli Hamidiye Etfal Research and Training Hospital, Binbasi Refikbey sk, No: 9/5 Sisli, Istanbul, Turkey.
Department of Obstetrics and Gynecology, Duzce University Faculty of Medicine, Duzce, Turkey.
Arch Gynecol Obstet. 2018 Jun;297(6):1483-1493. doi: 10.1007/s00404-018-4755-z. Epub 2018 Mar 19.
To compare the efficacy of needleless mini-sling placed either retropubic (U-shape) or trans-obturator (hammock-shape) to treat stress urinary incontinence.
One hundred and twenty six women were randomized in a 2:1 ratio to receive hammock-shaped or U-shaped of Contasure-NDL.
All surgical procedures were performed by one senior surgeon experienced in anti-incontinence surgery with mesh. Cough-stress test was considered for objective outcome. Subjective outcomes consisted of International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Patient Global Impression of Improvement (PGI-I) and three-item Likert scale to measure satisfaction. Assessments were performed preoperatively and at postoperative 6th, 12th and 18th month.
The objective cure rates at postoperative 6th and 12th month were significantly lower in U-shape group compared to hammock-shape group (85.4 vs. 96.4%; p = 0.034) and was comparable with hammock-shape group at 18 month postoperative (90.2 vs. 96.4%, respectively; p = 0.216). The subjective cure rates at postoperative 6th, 12th and 18th month were similar between groups (90.2/90.2/100% vs. 96.4/96.4/96.4%, respectively; p > 0.05). Median of total ICIQ-SF scores was significantly lower in hammock-shaped group (1.62 ± 2.92) compared to U-shape (3.80 ± 2.64) at 18th month (p < 0.001). The rate of patients reported as very satisfied or satisfied to the Likert scale was 90.2% in U-shape group and 96.4% in hammock group. Patients' responses to PGI-I were majorly distributed to "much better" and "very much better" with a mean score of 1.93 ± 2 in U-shape and 1.33 ± 1 in hammock group at 18th month of follow-up (p < 0.001).
U-shape placement of needleless single-incision mini-sling mimicking the retropubic route did not satisfy in achieving the patient's goal when compared to hammock-shape placement.
比较耻骨后（U形）或经闭孔（吊床形）放置无针迷你吊带治疗压力性尿失禁的疗效。
126名女性按2:1的比例随机分组，接受吊床形或U形的Contasure-NDL吊带。
所有手术均由一名有抗尿失禁手术网片经验的资深外科医生进行。以咳嗽压力试验作为客观疗效指标。主观疗效指标包括国际尿失禁咨询问卷简表（ICIQ-SF）、患者总体改善印象（PGI-I）以及用于衡量满意度的三项李克特量表。在术前以及术后第6、12和18个月进行评估。
术后第6个月和12个月时，U形组的客观治愈率显著低于吊床形组（分别为85.4%对96.4%；p = 0.034），术后18个月时与吊床形组相当（分别为90.2%对96.4%；p = 0.216）。术后第6、12和18个月时，两组的主观治愈率相似（分别为90.2/90.2/100%对96.4/96.4/96.4%；p > 0.05）。在第18个月时，吊床形组的ICIQ-SF总分中位数（1.62 ± 2.92）显著低于U形组（3.80 ± 2.64）（p < 0.001）。在李克特量表中，报告非常满意或满意的患者比例在U形组为90.2%，在吊床形组为96.4%。在随访的第18个月，患者对PGI-I的回答主要分布在“好多了”和“非常好多了”，U形组的平均评分为1.93 ± 2，吊床形组为1.33 ± 1（p < 0.001）。
与吊床形放置相比，模仿耻骨后路径的无针单切口迷你吊带U形放置在实现患者目标方面并不理想。
