Department of Obstetrics & Gynecology, the Department of Community Health Sciences, the Division of Urology, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, the Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, British Columbia, the Department of Obstetrics & Gynecology, University of Manitoba, Winnipeg, Manitoba, the Department of Obstetrics & Gynecology, University of Toronto, Toronto, Ontario, the Department of Obstetrics & Gynecology, University of Alberta, Edmonton, Alberta, Canada; and the Department of Obstetrics & Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.
Obstet Gynecol. 2020 Sep;136(3):471-481. doi: 10.1097/AOG.0000000000004027.
To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery.
The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome.
From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery.
Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique.
ClinicalTrials.gov, NCT02480231.
Boston Scientific.
评估与尿道下使用巴氏夹保持的胶带环相比，使用梅奥剪刀作为尿道下的间隔物是否会导致耻骨后尿道中段吊带手术后 12 个月出现不同的膀胱异常结果。
MUST（尿道中段吊带张力）试验是一项随机、双盲、多中心临床试验，将女性分配为使用剪刀或巴氏夹技术对其耻骨后尿道中段吊带进行张力。主要结局（膀胱异常）是持续性压力性尿失禁（SUI）、膀胱过度活动症和尿潴留的综合指标。次要结局包括综合结局、术后导尿、尿失禁相关问卷、重复尿失禁治疗和尿流率。每个臂（N=318）计划纳入 159 例的样本量（N=318），用于假设主要结局有 10%差异的优效性试验。
2015 年 9 月至 2017 年 12 月，共筛选了 506 名女性，其中 318 名被随机分配。每个臂的基线特征相似。12 个月时，253 名（79.6%）女性提供了主要结局信息：128 名接受剪刀张力的尿道中段吊带患者中有 40 名（31.3%）出现膀胱异常，而 125 名接受巴氏夹张力的患者中有 23 名（18.4%）出现膀胱异常（P=.018，相对差异 12.9%）。二次分析显示，在导尿时间中位数和需要吊带松解的尿潴留女性比例方面，巴氏夹更具优势。尿流率参数表明剪刀技术更具限制性。剪刀臂的网片侵蚀率较低。手术后患者报告持续 SUI 的女性比例没有差异。
使用巴氏夹张力的女性膀胱异常结果的发生率低 12.9%。两种技术在 12 个月时均为 SUI 提供了相似的患者报告治愈率。使用剪刀张力的女性发生梗阻的干预措施更多，而使用巴氏夹张力的女性网片侵蚀率更高。这些关于术后过程差异的信息使外科医生能够在术前更好地为患者提供咨询或调整他们的技术选择。
ClinicalTrials.gov，NCT02480231。
波士顿科学公司。
