Division of Urogynecology, Northwell System, Great Neck, the Biostatistics Unit, Feinstein Institute for Medical Research at Northwell System, Manhasset, and the Department of Molecular Medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.
Obstet Gynecol. 2019 Apr;133(4):675-682. doi: 10.1097/AOG.0000000000003159.
To estimate whether the urinary force of stream method is noninferior to a standard fill voiding trial for rate of catheterization within 6 weeks after apical prolapse surgery in those discharged without a catheter.
A noninferiority randomized controlled trial was conducted in postoperative women comparing force of stream with standard fill voiding trials after vaginal, abdominal, or laparoscopic-robotic apical pelvic organ prolapse (POP) surgery. Before discharge, women in both groups were backfilled with 300 mL normal saline. Successful voiding criteria in the force of stream group was subjective force of stream of at least 50 using a visual analog scale; reporting less than 50 prompted a bladder scan. Successful voiding was defined as a postvoid residual volume of less than 500 mL. For the standard fill voiding trial group, voiding two thirds of the instilled amount indicated success. The primary outcome was the rate of catheterization within the 6-week postoperative period after surgical repair of apical prolapse among those discharged without a urinary catheter. Secondary endpoints included trial of void failure rates. A sample size of 59 patients per group who passed trial of void at discharge was needed to achieve 80% power using a noninferiority margin (delta of 10%). Total enrollment of 169 patients was necessary to account for an estimated 30% trial of void failure rate.
From April 2016 and April 2017, 184 patients were enrolled (six enrolled before the trial registration date), with the first patient enrolled on April 1, 2016. One hundred seventy-four patients were randomized (86 in the force of stream group and 88 in the standard fill voiding trial group). No differences were observed in demographic or perioperative characteristics, except for stage 2 apical prolapse (52% in the force of stream group vs 36% in the standard fill voiding trial group). For the primary outcome, similar rates were found in those patients who passed their trial of void but subsequently needed catheterization for voiding dysfunction (force of stream 2.8% [2/71] vs standard fill voiding trial 3.1% [2/64]; difference -0.3%, 95% CI -8.69% to 8.08%). The incidence of trial of void failures at discharge was similar (force of stream 17.4% [15/86] vs standard fill voiding trial 26.4% [23/87]; risk ratio 0.65, 95% CI 0.37-1.18, P=nonsignificant).
Force of stream was noninferior to standard fill voiding trial when comparing the rate of catheter insertion during the 6-week postoperative period after apical POP surgery in those discharged without a catheter.
ClinicalTrials.gov, NCT02753920.
评估在无导尿管出院的患者中，与标准充盈性排尿试验相比，尿流力法在 apical prolapse 手术后 6 周内导尿率的非劣效性。
对接受阴道、腹部或腹腔镜机器人 apical pelvic organ prolapse (POP) 手术后的患者进行了一项尿流力法与标准充盈性排尿试验的非劣效性随机对照试验。在两组患者出院前，均使用 300ml 生理盐水进行回灌。在尿流力组中，成功排尿的标准是使用视觉模拟量表主观评估至少 50 的尿流强度；报告少于 50 则提示需要进行膀胱扫描。成功排尿定义为残余尿量小于 500ml。对于标准充盈性排尿试验组，排空三分之二的注入量表示成功。主要结局是在无导尿管出院的 apical prolapse 手术后 6 周内的导尿率。次要终点包括排尿失败率。每组需要 59 例通过出院时的排尿试验才能使用非劣效性边界（10%的差值）实现 80%的效能。总共有 169 名患者入组，以应对预计 30%的排尿试验失败率。
2016 年 4 月至 2017 年 4 月，共纳入 184 名患者（其中 6 名在试验注册日期前入组），首位患者于 2016 年 4 月 1 日入组。174 名患者被随机分组（尿流力组 86 例，标准充盈性排尿试验组 88 例）。除了 2 期 apical prolapse（尿流力组 52%，标准充盈性排尿试验组 36%），两组在人口统计学和围手术期特征方面没有差异。对于主要结局，虽然通过了试验但随后因排尿功能障碍需要导尿的患者中，两组的导尿率相似（尿流力组 2.8%[2/71]vs标准充盈性排尿试验组 3.1%[2/64]；差值-0.3%，95%CI-8.69%至 8.08%）。出院时的排尿试验失败发生率也相似（尿流力组 17.4%[15/86]vs标准充盈性排尿试验组 26.4%[23/87]；风险比 0.65，95%CI 0.37-1.18，P=非显著）。
在无导尿管出院的 apical POP 手术后 6 周内，与标准充盈性排尿试验相比，尿流力法在导尿率方面无劣效性。
ClinicalTrials.gov，NCT02753920。
