Kenton Kimberly, Stoddard Anne M, Zyczynski Halina, Albo Michael, Rickey Leslie, Norton Peggy, Wai Clifford, Kraus Stephen R, Sirls Larry T, Kusek John W, Litman Heather J, Chang Robert P, Richter Holly E
Northwestern University, Chicago, Illinois.
New England Research Institutes, Watertown, Massachusetts.
J Urol. 2015 Jan;193(1):203-10. doi: 10.1016/j.juro.2014.08.089. Epub 2014 Aug 23.
Few studies have characterized longer-term outcomes after retropubic and transobturator mid urethral slings.
Women completing 2-year participation in a randomized equivalence trial who had not undergone surgical re-treatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no re-treatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events.
Of 597 women 404 (68%) from the original trial enrolled in the study. Five years after surgical treatment success was 7.9% greater in women assigned to the retropubic sling compared to the transobturator sling (51.3% vs 43.4%, 95% CI -1.4, 17.2), not meeting prespecified criteria for equivalence. Satisfaction decreased during 5 years but remained high and similar between arms (retropubic sling 79% vs transobturator sling 85%, p=0.15). Urinary symptoms and quality of life worsened with time (p <0.001), and women with a retropubic sling reported greater urinary urgency (p=0.001), more negative impact on quality of life (p=0.02) and worse sexual function (p=0.001). There was no difference in the proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic sling 3, transobturator sling 4).
Treatment success decreased during 5 years for retropubic and transobturator slings, and did not meet the prespecified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing a transobturator sling procedure reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.
很少有研究对耻骨后和经闭孔尿道中段吊带术后的长期疗效进行描述。
完成一项随机等效性试验2年且未因压力性尿失禁接受手术再治疗的女性被邀请参加一项为期5年的观察性队列研究。主要结局指标治疗成功定义为无需再治疗或自我报告无压力性尿失禁症状。次要结局指标包括泌尿系统症状、生活质量、满意度、性功能及不良事件。
在原试验的597名女性中,404名(68%)参与了本研究。手术治疗5年后,耻骨后吊带组女性的治疗成功率比经闭孔吊带组高7.9%(51.3%对43.4%,95%可信区间为-1.4至17.2),未达到预先设定的等效标准。5年间满意度有所下降,但仍保持较高水平且两组间相似(耻骨后吊带组79%对经闭孔吊带组85%,p=0.15)。泌尿系统症状和生活质量随时间恶化(p<0.001),耻骨后吊带组女性报告有更强烈的尿急感(p=0.001)、对生活质量有更大的负面影响(p=0.02)以及更差的性功能(p=0.001)。至少经历1次不良事件的女性比例无差异(p=0.17)。发现7例新的网片侵蚀(耻骨后吊带组3例,经闭孔吊带组4例)。
耻骨后和经闭孔吊带术后5年治疗成功率下降,未达到预先设定的等效标准,耻骨后吊带显示出轻微优势。然而,两组满意度均保持较高。接受经闭孔吊带手术的女性报告泌尿系统症状和性功能有更持续的改善。随着时间推移,两组均出现新的网片侵蚀,尽管发生率同样较低。