Lord H Elizabeth, Taylor John D, Finn Judith C, Tsokos Nicolas, Jeffery J Timothy, Atherton Michelle J, Evans Sharon F, Bremner Alexandra P, Elder Gillian O, Holman C D'Arcy J
Faculty of Medicine and Dentistry, School of Population Health, University of Western Australia, Western Australia, Australia.
BJU Int. 2006 Aug;98(2):367-76. doi: 10.1111/j.1464-410X.2006.06333.x.
To establish the equivalence between the tension-free vaginal tape (TVT) and the suprapubic urethral support sling (SPARC). Approximately 35% of women have stress urinary incontinence (SUI), and although TVT is now perceived as the standard treatment, the SPARC is a very similar procedure and is thought to have fewer peri-operative complications.
Patients with clinical SUI were recruited from public and private urology/urogynaecology clinics, and participated in the trial of TVT vs SPARC. The primary outcome was bladder perforation; secondary outcomes were blood loss, voiding difficulty, urgency, and cure of SUI symptoms. Sample size calculations, based on an estimated 2% perforation rate, showed that 290 patients would be needed to detect a clinically significant difference of 5%. Stratification was by previous incontinence surgery and the experience of the surgeon.
There were 301 operations; the difference in bladder perforations was not statistically significant, at one/147 TVT (0.7%), and three/154 SPARC (1.9%), with the difference in rate of 0.013 (95% confidence interval (CI) - 0.01 to 0.04; odds ratio 2.89, 95% CI 0.30-28.21; P = 0.62), and nor were differences in estimated blood loss of >100 mL (TVT, 32/147, 21.8%; SPARC 28/154, 18.2%); de novo urgency (TVT 15/37, 40.5%; SPARC 14/33, 42.4%), objective cure (TVT 143/147, 97.3%; SPARC 148/152, 97.4%) or vaginal mesh erosion (TVT 7/147, 4.8%; SPARC 16/152, 10.5%). Acute urinary retention (TVT none of 147; SPARC 10/154, 6.5%; odds ratio infinity, 95% CI 2.2-infinity; P = 0.002) and subjective cure (TVT 128/147, 87.1%; SPARC 117/153, 76.5%; odds ratio 2.07, 95% CI 1.13-3.81; P = 0.03) were statistically significantly different.
These results are consistent with clinical equivalence between TVT and SPARC for bladder perforation. There was no statistically significant difference between TVT and SPARC in blood loss, urgency or objective cure of SUI symptoms at 6 weeks. However, SPARC was more difficult to adjust correctly, and a statistically significant number of patients required loosening of the tape in theatre (P = 0.002). TVT had a lower rate of vaginal erosion and a statistically significantly higher cure rate of subjective SUI symptoms than SPARC. Overall, voiding difficulty (loosening of the tape), urgency and vaginal mesh erosion were the most important clinical problems. This trial showed the importance of testing new devices which appear to be similar, but which might have relevant differences. There was no financial assistance for this study, and a long-term follow up is planned.
确立无张力阴道吊带术（TVT）与耻骨上尿道支撑吊带术（SPARC）之间的等效性。约35%的女性患有压力性尿失禁（SUI），尽管TVT目前被视为标准治疗方法，但SPARC是一种非常相似的手术，且被认为围手术期并发症较少。
从公立和私立泌尿外科/泌尿妇科诊所招募临床诊断为SUI的患者，参与TVT与SPARC对比试验。主要结局为膀胱穿孔；次要结局为失血量、排尿困难、尿急及SUI症状的治愈情况。基于估计2%的穿孔率进行样本量计算，结果显示需要290例患者才能检测出5%的具有临床意义的差异。分层依据既往尿失禁手术情况及外科医生的经验。
共进行了301例手术；膀胱穿孔差异无统计学意义，TVT组1/147例（0.7%），SPARC组3/154例（1.9%），发生率差异为0.013（95%置信区间（CI）-0.01至0.04；优势比2.89，95%CI 0.30 - 28.21；P = 0.62），估计失血量>100 mL的差异也无统计学意义（TVT组32/147例，21.8%；SPARC组28/154例，18.2%）；新发尿急（TVT组15/37例，40.5%；SPARC组14/33例，42.4%）、客观治愈率（TVT组143/147例，97.3%；SPARC组148/152例，97.4%）或阴道网片侵蚀（TVT组7/147例，4.8%；SPARC组16/152例，10.5%）方面也无差异。急性尿潴留（TVT组147例中无；SPARC组10/154例，6.5%；优势比无穷大，95%CI 2.2 - 无穷大；P = 0.002）和主观治愈率（TVT组128/147例，87.1%；SPARC组117/153例，76.5%；优势比2.07，95%CI 1.13 - 3.81；P = 0.03）差异有统计学意义。
这些结果表明TVT与SPARC在膀胱穿孔方面具有临床等效性。在6周时，TVT与SPARC在失血量、尿急或SUI症状的客观治愈率方面无统计学显著差异。然而，SPARC更难正确调整，且有统计学意义数量的患者需要在手术室松开吊带（P = 0.002）。TVT的阴道侵蚀发生率较低，主观SUI症状的治愈率在统计学上显著高于SPARC。总体而言，排尿困难（吊带松动）、尿急和阴道网片侵蚀是最重要的临床问题。该试验表明了对看似相似但可能存在相关差异的新器械进行测试的重要性。本研究无资金资助，计划进行长期随访。
