Hospital de São João, Serviço de Urologia, Porto, Portugal.
Eur Urol. 2011 Jun;59(6):940-4. doi: 10.1016/j.eururo.2011.01.018. Epub 2011 Jan 21.
Contemporary surgical treatment of female stress urinary incontinence (SUI) includes retropubic and transobturator (TO) midurethral slings (MUS). Case series of single-incision slings (SIS) have shown similar outcomes with lower morbidity.
Our aim was to assess the cure rates, complications, and quality-of-life impact of one standard TO MUS and two SIS.
DESIGN, SETTING, AND PARTICIPANTS: Ninety consecutive patients with clinically and urodynamically proven SUI were enrolled in an exploratory randomised phase 2 trial. Patients with previous SUI surgery, major pelvic organ prolapse, mixed incontinence, or detrusor overactivity were excluded.
Patients were treated randomly with TVT-O, TVT-Secur, or Mini-Arc.
Postoperative visits were scheduled at 6 and 12 mo. The King's Health Questionnaire (KHQ) was repeated at 6 mo. Cure was defined as the absence of urine leakage, no pad use, and a negative cough test at 12 mo. Pain and other complications were also investigated.
Cure rate was 83% after TVT-O, 67% after TVT-Secur, and 87% after Mini-Arc. Improvement was found in 10%, 13%, and 7% of the patients, respectively. Failures were 7% after TVT-O and Mini-Arc and 20% after TVT-Secur. TVT-O and Mini-Arc improved at least 15 points in >80% of the patients in six KHQ domains, whereas TVT-Secur could only achieve improvement in three of the nine domains. The pain score was lower in the Mini-Arc group. Complications were more numerous after TVT-O. This study has the limitations inherent in a phase 2 trial with a follow-up limited to 12 mo.
Mini-Arc offers cure and improvement rates similar to TVT-O, whereas TVT-Secur may yield an inferior outcome. These findings recommend the urgent launch of large randomised phase 3 studies comparing conventional MUS with SIS, with Mini-Arc the advised option.
女性压力性尿失禁（SUI）的当代手术治疗包括耻骨后和经闭孔（TO）尿道中段吊带（MUS）。单切口吊带（SIS）的病例系列研究显示，其具有相似的疗效，且发病率更低。
我们旨在评估一种标准的 TO-MUS 和两种 SIS 的治愈率、并发症和生活质量影响。
设计、设置和参与者：90 例经临床和尿动力学证实的 SUI 患者参加了一项探索性的 2 期随机试验。排除有 SUI 手术史、严重盆腔器官脱垂、混合性尿失禁或逼尿肌过度活动的患者。
患者随机接受 TVT-O、TVT-Secur 或 Mini-Arc 治疗。
术后随访分别在 6 个月和 12 个月进行。6 个月时重复使用 King's 健康问卷（KHQ）。治愈定义为 12 个月时无尿漏、无垫使用和咳嗽试验阴性。还调查了疼痛和其他并发症。
TVT-O 组的治愈率为 83%，TVT-Secur 组为 67%，Mini-Arc 组为 87%。分别有 10%、13%和 7%的患者得到改善。TVT-O 和 Mini-Arc 组的失败率为 7%，TVT-Secur 组为 20%。TVT-O 和 Mini-Arc 在六个 KHQ 领域中至少有 80%的患者改善了 15 分以上，而 TVT-Secur 只能在九个领域中的三个领域中改善。Mini-Arc 组的疼痛评分较低。TVT-O 组的并发症较多。这项研究具有 2 期试验固有的局限性，随访时间限于 12 个月。
Mini-Arc 的治愈率和改善率与 TVT-O 相似，而 TVT-Secur 的疗效可能较差。这些发现强烈建议尽快开展比较传统 MUS 与 SIS 的大型随机 3 期研究，建议使用 Mini-Arc。
