Department of Obstetrics and Gynecology, Ziekenhuis Oost-Limburg, Genk, Belgium.
J Urol. 2011 Apr;185(4):1356-62. doi: 10.1016/j.juro.2010.11.083. Epub 2011 Feb 22.
Mid urethral sling procedures have become the surgical treatment of choice for female stress urinary incontinence. Innovative modifications of mid urethral sling procedures were recently introduced with the claim of offering similar efficacy and decreased morbidity. We compared the efficacy and morbidity of an innovative single incision mid urethral tape and an established transobturator procedure.
We performed a prospective, randomized, controlled trial in 6 teaching hospitals in Belgium and The Netherlands between 2007 and 2009. A total of 96 patients received a TVT Secur™ single incision sling and 98 received a TVT™ Obturator System. We collected data on patient characteristics, surgery related parameters, adverse events, clinical followup, Urogenital Distress Inventory and SF-36® scores, validated questionnaires on daily life activities and visual analog scores objectifying pain. Followup was 1 year.
One-year followup was available for 75 single incision sling and 85 obturator system cases. Stress urinary incontinence could be objectified in 16.4% of the patients with a single incision sling and in 2.4% with an obturator system (p <0.05). Stress urinary incontinence was subjectively reported by 24% of single incision sling and 8% of obturator system patients (p <0.05). One year after surgery the mean ± SD UDI incontinence domain score in the single incision sling and obturator system groups was 21 ± 24 and 13 ± 21, respectively (p <0.01). Patients with a single incision sling experienced significantly less pain during the first 2 weeks after surgery (p <0.05) and returned significantly earlier to normal daily activity. The OR of re-intervention for stress urinary incontinence 1 year after receiving a single incision sling vs an obturator system was 2.3 (95% CI 1.9-2.7).
The single incision sling procedure is associated with less postoperative pain and a lower objective cure rate than the obturator system procedure.
尿道中段吊带术已成为女性压力性尿失禁的首选手术治疗方法。最近，创新性地对尿道中段吊带术进行了改良，据称其疗效相似，但发病率降低。我们比较了一种新型单切口尿道中段吊带术与一种成熟的经闭孔入路手术的疗效和发病率。
我们在 2007 年至 2009 年期间在比利时和荷兰的 6 所教学医院进行了一项前瞻性、随机、对照试验。共有 96 例患者接受了 TVT Secur™单切口吊带术，98 例患者接受了 TVT™经闭孔系统手术。我们收集了患者特征、手术相关参数、不良事件、临床随访、尿生殖窘迫量表和 SF-36®评分、日常生活活动验证问卷以及疼痛的视觉模拟评分。随访时间为 1 年。
96 例单切口吊带术和 98 例经闭孔系统手术的患者均完成了 1 年随访。16.4%的单切口吊带术患者和 2.4%的经闭孔系统患者的压力性尿失禁可以客观化（p<0.05）。24%的单切口吊带术患者和 8%的经闭孔系统患者主观报告有压力性尿失禁（p<0.05）。术后 1 年，单切口吊带术和经闭孔系统组的 UDI 失禁域评分分别为 21±24 和 13±21（p<0.01）。单切口吊带术患者术后前 2 周疼痛明显减轻（p<0.05），更早恢复正常日常活动。术后 1 年，因压力性尿失禁再次手术的 OR 为 2.3（95%CI 1.9-2.7）。
与经闭孔系统手术相比，单切口吊带术术后疼痛较轻，客观治愈率较低。
