中段尿道悬吊手术研究：患者尿道控制力下降，第5年患者满意度仍较高

奥兰多——耶鲁大学泌尿科专家Leslie M. Rickey博士在美国泌尿外科学会年会的最佳研究摘要议会上报告了一项中段尿道悬吊手术的随访研究，研究发现，经闭孔中段尿道悬吊手术以及经耻骨后中段尿道悬吊手术治疗女性尿失禁患者的第5年成功率相当，但经闭孔的患者的症状缓解更明显。但两组患者的总体满意度比例相近。

中段尿道悬吊手术研究（TOMUS）中共597例患者中的404例患者完成了延长随访（E-TOMUS），经闭孔组与经耻骨后组患者间成功率无显著差异（43% vs. 51%），且随时间推移而降低。虽然经耻骨后中段尿道悬吊手术的成功率高出近8%，但在第1年或第5年并没有达到预设的治疗标准。

两组受试者的压力性尿失禁症状随着时间的推移持续增加，第5年时组间没有差异；经耻骨后组中急性症状随时间推移而增加的情况更加显著。

“虽然从基线来看，尿急症状和性功能障碍得以改善，但总体上还是随时间推移不断恶化，”Rickey博士指出，经耻骨后组的情况恶化更为显著。

然而，两组中表示完全或大部分满意的患者比例仍保持相似（虽然随着时间推移满意度比例分别从92%和93%下降至80%和85%中）。按照患者总体印象-改善量表（PGI-I）评分，经闭孔组患者报告改善尿路症状的数量几乎是经耻骨后组的两倍，Rickey博士说。

共有10%的女性报告了不良事件（主要是尿路感染或网带暴露）或严重不良事件；两组间无差异。共6例需要干预治疗的严重不良事件，包括每组各1例的网带侵蚀和经耻骨后组的4例尿路感染。

“重要的是，在术后3～5年内又出现7例新发的网带暴露病例，”Rickey博士说报告，经耻骨后组3例和经闭孔组的4例。

参与延长随访的TOMUS受试者在接受初始手术后均未再次接受压力性尿失禁手术治疗，每年完成面对面的临床随访，包括接受盆腔检查、报告症状、网带情况，以及生活质量问卷调查。

治疗成功定义为无复诊压力性尿失禁，同时使用医学、流行病学和老龄化社会方面问卷量表（MESA）评估判断无压力性尿失禁症状。

“总之，无论是经耻骨后还是经闭孔的中段尿道悬吊手术，5年后患者的尿道控制能力确实下降，并没有达到预先设定的标准。但两组满意度均维持较高比例。但经闭孔中段尿道悬吊手术后患者的泌尿系统症状和生活质量在第5年时得到更多的改善，网带侵蚀率仅为1.7%，”Rickey博士说。

该研究由糖尿病、消化和肾脏疾病国家研究所资助。作者报告无利益冲突。

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By: SHARON WORCESTER, Ob.Gyn. News Digital Network

AT THE AUA ANNUAL MEETING

VITALS

Key clinical point: The benefits of midurethral slings persisted 5 years in the majority of women.

Major finding: Overall rates of satisfaction at 5 years were 79% and 85% with retropubic midurethral and transobturator midurethral slings, respectively.

Data source: Extended follow-up of 404 patients from the TOMUS trial (E-TOMUS).

Disclosures: This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.

ORLANDO – Success rates at 5 years were similar in women treated with a transobturator midurethral sling and women treated with a retropubic midurethral sling, but the transobturator patients were more likely to report an easing of symptoms, according to an extension of the Trial of Mid-Urethral Slings.

Overall satisfaction was similar in the two groups, Dr. Leslie M. Rickey reported during a Best Abstract session at the annual meeting of the American Urological Association.

Of 597 subjects in the Trial of Midurethral Slings (TOMUS), 404 participated in the extension phase (E-TOMUS). There was no significant difference in success rates – which declined over time – between those in the transobturator group and those in the retropubic group (43% vs. 51%).

However, treatment success for retropubic midurethral slings was nearly 8% higher and did not meet equivalency criteria at 1 or 5 years, said Dr. Rickey, a urologist at Yale University, New Haven, Conn., who presented on behalf of Dr. Kimberly S. Kenton and the Urinary Incontinence Treatment Network.

Stress incontinence symptoms continued to increase over time in both groups but did not differ between the groups at 5 years; urge symptoms also increased over time but were reported significantly more often in the retropubic midurethral sling group.

"Overall urgency symptoms and sexual dysfunction, although still improved from baseline, did worsen over time," Dr. Rickey said, noting that they worsened significantly more overall in the retropubic group.

However, the proportion of patients who were completely or mostly satisfied remained similar in the groups (although it decreased from 92% and 93% to 80% and 85% in the groups, respectively, over time). Those in the transobturator group were almost twice as likely to report improvement in their urinary condition as measured by the Patient Global Impression of Improvement scale (odds ratio, 1.94), Dr. Rickey said.

With respect to adverse events, 10% of women overall experienced an adverse event (mainly urinary tract infections or mesh exposure) or serious adverse event; the rate did not differ between the groups. There were six serious adverse events requiring intervention, including one case of mesh erosion in each group and four urinary tract infections in the retropubic midurethral sling group.

"Importantly, there were seven new mesh exposures in years 3-5 after surgery," Dr. Rickey said, noting that three occurred in the retropubic midurethral sling group and four occurred in the transobturator midurethral sling group.

Women included in the extension phase were TOMUS participants who did not undergo surgical retreatment for stress urinary incontinence after the initial procedure. Participants completed annual in-person visits, including pelvic examination, symptom, mesh, and quality of life questionnaires.

Treatment success was defined as no retreatment for stress urinary incontinence, and no self-reported stress urinary incontinence symptoms using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, she said.

"In conclusion, the 5-year continence rates did decline after either retropubic midurethral sling or transobturator sling, and did not meet prespecified criteria for equivalency. Satisfaction does remain high in both groups. In general, urinary symptoms and quality of life were more improved at 5 years after the transobturator approach, and mesh erosion rates remain low at 1.7%," she said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The authors reported having no disclosures.