Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, Helsinki, Finland.
Doctoral Programme in Clinical Research, Helsinki University, Helsinki, Finland.
J Urol. 2020 Feb;203(2):372-378. doi: 10.1097/JU.0000000000000517. Epub 2019 Sep 3.
We evaluated whether polyacrylamide hydrogel is noninferior to tension-free vaginal tape to treat women with primary stress urinary incontinence.
In this controlled noninferiority clinical trial patients with primary stress urinary incontinence were randomized to tension-free vaginal tape or polyacrylamide hydrogel treatment. The primary outcome was patient satisfaction and secondary outcomes were effectiveness in reducing urinary leakage and complications at 1-year followup. For statistical power significance was considered at 5%, power was set at 80% and the noninferiority limit was 20% with a 10% expected dropout rate.
A total of 224 women with primary stress urinary incontinence entered the study between September 28, 2015 and March 1, 2017. Of the women 111 were randomized to tension-free vaginal tape and 113 were randomized to polyacrylamide hydrogel. At 1 year a satisfaction score of 80 or greater on a visual analogue scale of 0 to 100 was reached in 95.0% and 59.8% of patients treated with tension-free vaginal tape and polyacrylamide hydrogel, respectively. Thus, polyacrylamide hydrogel did not meet the noninferiority criteria set in our study. As secondary outcomes, the cough stress test was negative in 95.0% of tension-free vaginal tape cases vs 66.4% of polyacrylamide hydrogel cases (difference 28.6%, 95% CI 18.4-38.5). However, most perioperative complications, including those in 19 tension-free vaginal tape cases vs 3 polyacrylamide hydrogel cases (difference 16.0%, 95% CI 7.8-24.9), and all 6 reoperations due to complications (difference 5.9%, 95% CI 1.2-12.4) were associated with tension-free vaginal tape.
Mid urethral tension-free vaginal tape slings were associated with better satisfaction and cure rates than polyacrylamide hydrogel in women with primary stress urinary incontinence. However, complications were mainly associated with tension-free vaginal tape. Thus, tension-free vaginal tape should be offered as first line treatment in women who expect to be completely cured by the initial treatment and are willing to accept the complication risks. Since polyacrylamide hydrogel treatment also provides high satisfaction and cure rates, women with primary stress urinary incontinence can be offered polyacrylamide hydrogel as an alternative treatment.
我们评估聚丙烯酰胺水凝胶是否不劣于经阴道无张力吊带治疗原发性压力性尿失禁的女性。
在这项对照非劣效性临床试验中，患有原发性压力性尿失禁的患者被随机分为经阴道无张力吊带或聚丙烯酰胺水凝胶治疗组。主要结局是患者满意度，次要结局是治疗 1 年后减少尿漏和并发症的效果。为了达到统计学意义，我们设定了 5%的显著性水平，设定了 80%的效能，非劣效性界限为 20%，预计脱落率为 10%。
2015 年 9 月 28 日至 2017 年 3 月 1 日期间，共有 224 名患有原发性压力性尿失禁的女性进入研究。其中 111 名女性被随机分配到经阴道无张力吊带组，113 名女性被随机分配到聚丙烯酰胺水凝胶组。治疗 1 年后，视觉模拟评分 0 到 100 分中得分 80 或以上的患者分别有 95.0%和 59.8%接受经阴道无张力吊带和聚丙烯酰胺水凝胶治疗。因此，聚丙烯酰胺水凝胶不符合我们研究设定的非劣效性标准。作为次要结局，在经阴道无张力吊带组中，咳嗽应激试验为阴性的比例为 95.0%，而在聚丙烯酰胺水凝胶组中为 66.4%（差异 28.6%，95%置信区间 18.4-38.5）。然而，大多数围手术期并发症，包括 19 例经阴道无张力吊带组和 3 例聚丙烯酰胺水凝胶组（差异 16.0%，95%置信区间 7.8-24.9），以及所有 6 例因并发症而进行的再次手术（差异 5.9%，95%置信区间 1.2-12.4）均与经阴道无张力吊带相关。
在患有原发性压力性尿失禁的女性中，尿道中段经阴道无张力吊带较聚丙烯酰胺水凝胶有更好的满意度和治愈率。然而，并发症主要与经阴道无张力吊带有关。因此，对于那些希望通过初次治疗完全治愈且愿意接受并发症风险的女性，经阴道无张力吊带应作为首选治疗方法。由于聚丙烯酰胺水凝胶治疗也提供了较高的满意度和治愈率，患有原发性压力性尿失禁的女性可选择聚丙烯酰胺水凝胶作为替代治疗方法。
