Department of Obstetrics and Gynecology, EOC - Beata Vergine Hospital, Mendrisio, Switzerland.
Department of Obstetrics and Gynecology, G. Fornaroli Hospital, Magenta, Italy.
BJU Int. 2018 Jul;122(1):113-117. doi: 10.1111/bju.14136. Epub 2018 Feb 22.
To assess the efficacy and safety of retropubic tension-free vaginal tape (TVT) 17 years after implantation for the treatment of female pure stress urinary incontinence (SUI).
A prospective study was conducted in two urogynaecological units in two countries. All consecutive women with urodynamically proven pure SUI treated by TVT were included. Patients with mixed incontinence and/or anatomical evidence of pelvic organ prolapse were excluded. Data regarding subjective outcomes (International Consultation on Incontinence Questionnaire-Short Form, Patient Global Impression of Improvement, and patient satisfaction scores), objective cure (stress test) rates, and adverse events were collected during follow-up. Univariable analysis was performed to investigate outcomes.
A total of 52 women underwent TVT implantation. At 17-year follow-up, 46 women (88.4%) were available for the evaluation. We did not find any significant change in surgical outcomes during this time. At 17 years after surgery, 41 of 46 women (89.1%) declared themselves cured (P = 0.98). Similarly, at 17-year evaluation, 42 of 46 women (91.4%) were objectively cured. No significant deterioration in objective cure rates was observed over time (P for trend 0.50). The univariate analysis did not find any risk factor statistically associated with the recurrence of SUI. Of the 46 women, 15 (32.6%) reported the onset of de novo overactive bladder at 17-year follow-up. No other late complications were reported.
The 17-year results of this study showed that TVT is a highly effective and safe option for the treatment of SUI.
评估经阴道耻骨后无张力悬吊带（TVT）植入 17 年后治疗女性单纯性压力性尿失禁（SUI）的疗效和安全性。
在两个国家的两个泌尿科单位进行了一项前瞻性研究。所有经尿动力学证实为单纯性 SUI 且接受 TVT 治疗的连续女性患者均被纳入研究。排除混合性尿失禁和/或盆腔器官脱垂解剖证据的患者。在随访期间收集了关于主观结局（国际尿失禁咨询问卷-简短表、患者总体改善印象和患者满意度评分）、客观治愈率（压力测试）和不良事件的数据。采用单变量分析来探讨结局。
共有 52 名女性接受了 TVT 植入术。在 17 年的随访中，46 名女性（88.4%）可进行评估。在此期间，我们未发现手术结局有任何显著变化。在术后 17 年，46 名女性中有 41 名（89.1%）自述治愈（P=0.98）。同样，在 17 年的评估中，46 名女性中有 42 名（91.4%）在客观上被治愈。随着时间的推移，客观治愈率没有明显恶化（趋势 P 值为 0.50）。单变量分析未发现任何与 SUI 复发有统计学关联的风险因素。在这 46 名女性中，有 15 名（32.6%）在 17 年随访时报告新发过度活动膀胱。未报告其他迟发性并发症。
本研究的 17 年结果表明，TVT 是治疗 SUI 的一种高度有效和安全的选择。
