University of Aberdeen, Aberdeen, Scotland, UK.
Urology. 2013 Sep;82(3):552-9. doi: 10.1016/j.urology.2013.02.080. Epub 2013 Jul 9.
To compare an adjustable anchored single incision mini-sling (SIMS-Ajust) vs tension-free vaginal tape-obturator (TVT-O) in the management of female stress urinary incontinence (SUI) with a minimum of 1-year follow-up.
We conducted a multicenter prospective randomized control trial (RCT) performed in 6 United Kingdom centers in the period between October 2009 and October 2011. Women were randomized to either SIMS-Ajust (C. R. Bard) performed under local anesthesia or TVT-O (Ethicon Inc.) performed under general anesthesia. Women completed validated symptom-severity and quality of life (QOL) questionnaires preoperatively and at 1 year. In addition, women completed the Patient Global Impression of Improvement (PGI-I) and underwent the Cough Stress Test (CST) at 1 year. The primary outcome at 12 months was the patient-reported success rate. Secondary outcomes included objective cure, reoperation rate, impact on women's urinary symptoms, QOL, and sexual function. Data was analyzed using SPSS-19 with significance level set at 5%.
One hundred thirty-seven women were randomized into 2 groups: the SIMS-Ajust group (n = 69) and the TVT-O group (n = 68). At 1 year, there were no significant differences in the patient-reported success rate (odds ratio [OR] 0.895, 95% confidence interval [CI] 0.344-2.330, P = 1.000), objectives success rate (OR 0.929, 95% CI 0.382-2.258, P = 1.00), and reoperation rates (OR 0.591, 95% CI 0.136-2.576, P = .721) between the SIMS-Ajust and the TVT-O groups, respectively. A comparable number of women reported cure/improvement of urgency (P = .658), significant improvement in QOL (P = .190), and sexual function (P = .699) in both groups.
Adjustable-anchored SIMS (Ajust) is associated with comparable patient-reported and objective success rates when compared to standard midurethral sling (SMUS, TVT-O) at a minimum of 1-year follow-up. The results should be interpreted with caution due to the relatively small cohort size. Long-term follow-up of this RCT is required to ascertain the durability of these results.
比较可调节锚定单切口吊带（SIMS-Ajust）与经阴道无张力吊带-闭孔器（TVT-O）在女性压力性尿失禁（SUI）管理中的效果，随访时间至少 1 年。
我们在 2009 年 10 月至 2011 年 10 月期间在英国的 6 个中心进行了一项多中心前瞻性随机对照试验（RCT）。患者随机分配至 SIMS-Ajust（C.R. Bard）组（局部麻醉）或 TVT-O（Ethicon Inc.）组（全身麻醉）。患者在术前和 1 年时完成了经过验证的症状严重程度和生活质量（QOL）问卷。此外，患者在 1 年时完成了患者总体印象改善（PGI-I）和咳嗽压力测试（CST）。12 个月时的主要结局是患者报告的成功率。次要结局包括客观治愈率、再次手术率、对女性尿失禁症状、QOL 和性功能的影响。使用 SPSS-19 进行数据分析，显著性水平设为 5%。
137 名患者被随机分为 2 组：SIMS-Ajust 组（n=69）和 TVT-O 组（n=68）。1 年后，患者报告的成功率（优势比 [OR] 0.895，95%置信区间 [CI] 0.344-2.330，P=1.000）、客观成功率（OR 0.929，95%CI 0.382-2.258，P=1.00）和再手术率（OR 0.591，95%CI 0.136-2.576，P=0.721）在 SIMS-Ajust 和 TVT-O 组之间均无显著差异。两组均有相当数量的女性报告尿失禁和急迫性症状得到缓解（P=0.658）、QOL 显著改善（P=0.190）和性功能改善（P=0.699）。
在至少 1 年的随访中，可调节锚定 SIMS（Ajust）与标准中尿道吊带（SMUS，TVT-O）相比，患者报告的成功率和客观成功率相当。由于队列规模相对较小，结果应谨慎解释。需要对这项 RCT 进行长期随访，以确定这些结果的持久性。
