University of Melbourne, Department of Surgery, Western Hospital, Victoria, Australia.
BJU Int. 2011 Apr;107 Suppl 3:43-6. doi: 10.1111/j.1464-410X.2011.10044.x.
• To ascertain if filling the bladder with warm normal saline before trial of void (TOV) reduces time to decision of outcome of TOV and time to discharge compared with standard in-dwelling catheter (IDC) removal in the outpatient setting.
• A prospective randomized controlled trial (not blinded) was carried out in the day procedure unit. Randomization was done using computer-generated random numbers. The sample size was calculated based on initial pilot data using α= 0.05 and β= 0.2 and a clinically important reduction of ≥60 min for time to decision of outcome of TOV (primary outcome measure). • In all, 60 consecutive patients were recruited from two referral sources: presentations of acute urinary retention to the emergency department and patients discharged home after failing TOV postoperatively. • The infusion method group (32 patients) had 300-500 mL warm normal saline infused into the bladder before removing their IDC and the control group (28) had standard IDC removal. • Data were collected and analysed using the two-tailed Mann-Whitney U-test. Statistical significance was set at P < 0.05.
• The median time to decision was 135.0 (95% confidence interval CI 95.0-190.0) min in the infusion group and 247.5 (95% CI 189.6-294.1) min in the control group. • Patients undergoing a bladder infusion had a shorter discharge time [180.0 (95% CI 126.0-226.9) min] than patients in the standard-IDC-removal group [262.5 (95% CI 233.8-315.0) min]. • The infusion arm shortened time to decision by 112.5 min (P < 0.001) and time to discharge by 82.5 min (P < 0.001). • Furthermore, patients in the infusion group were 1.56 times more likely to achieve catheter-free state after TOV (risk ratio 1.56, 95% CI 1.03-2.36; P= 0.03).
• The infusion method for TOV is safe and expeditious, making it ideal for the outpatient setting. This randomized study shows that the infusion method enables a rapid determination of outcome of TOV with a greater chance of success and shortened discharge times.
在日间手术病房进行了一项前瞻性随机对照试验(未设盲)。使用计算机生成的随机数进行随机分组。根据初步的试点数据,使用 α=0.05 和 β=0.2 计算样本量,并假设 TOV 结果的决定时间(主要观察指标)有≥60 分钟的临床重要减少。
共有 60 名连续患者从两个转诊来源招募:急诊科急性尿潴留的表现和术后失败 TOV 后出院回家的患者。
灌注组(32 名患者)在拔除 IDC 前给膀胱灌注 300-500 毫升温生理盐水,对照组(28 名)则采用标准 IDC 拔除。
使用双侧曼-惠特尼 U 检验收集和分析数据。统计学意义设为 P<0.05。
灌注组的中位决定时间为 135.0(95%置信区间 95.0-190.0)分钟,对照组为 247.5(95%置信区间 189.6-294.1)分钟。
接受膀胱灌注的患者出院时间更短[180.0(95%置信区间 126.0-226.9)分钟],而标准 IDC 拔除组为[262.5(95%置信区间 233.8-315.0)分钟]。
灌注组缩短了 112.5 分钟的决定时间(P<0.001)和 82.5 分钟的出院时间(P<0.001)。
此外,TOV 后,灌注组患者达到无导管状态的可能性增加了 1.56 倍(风险比 1.56,95%置信区间 1.03-2.36;P=0.03)。