OBJECTIVE To evaluate whether a single preoperative dose of tamsulosin reduces the time to postoperative void and time to discharge in patients who are undergoing minimally invasive hysterectomy. METHODS This single-center, block-randomized, placebo-controlled, double-blind superiority trial evaluated the effect of 0.4 mg tamsulosin compared with placebo on the time to void after hysterectomy. Patients who underwent outpatient minimally invasive hysterectomy were randomized to a single dose of tamsulosin or placebo 1 hour before surgery. All participants underwent a standardized backfill void trial to eliminate discrepancies in bladder volume that would otherwise affect the time to void. For our primary aim, we planned to enroll 150 participants to show a 30-minute reduction in the time to postoperative void (80% power, α<0.05). The secondary aim was to compare the time to discharge from the postanesthesia care unit. RESULTS From June 2021 through January 2023, 344 patients were screened, and 150 were included in the final data analysis: 77 in the tamsulosin group and 73 in the placebo group. The time to spontaneous void was not different between the tamsulosin and placebo groups (106 minutes vs 100 minutes, P=.5). In addition, there was no statistical difference in time to discharge from the postanesthesia care unit (144 minutes vs 156 minutes, P=.4). Demographics and surgical details were not different between each group. CONCLUSION A single dose of tamsulosin preoperatively does not lead to a decrease in postoperative time to void or time to discharge in patients undergoing minimally invasive hysterectomy for benign conditions. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT04859660.

中文翻译：

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坦索罗辛和子宫切除术后自发排空的时间：随机对照试验。


目的 评估术前单剂量坦索罗辛是否可以缩短接受微创子宫切除术的患者术后排尿时间和出院时间。方法 这项单中心、分组随机、安慰剂对照、双盲优效性试验评估了 0.4 mg 坦索罗辛与安慰剂相比对子宫切除术后排尿时间的影响。接受门诊微创子宫切除术的患者在术前 1 小时随机接受单剂量坦索罗辛或安慰剂。所有参与者都接受了标准化的回填排尿试验，以消除膀胱容量的差异，否则会影响排尿时间。对于我们的主要目标，我们计划招募 150 名参与者，以展示术后排尿时间缩短 30 分钟（80% 功效，α<0.05）。第二个目的是比较从麻醉后护理室出院的时间。结果从2021年6月至2023年1月，筛选了344名患者，150名患者纳入最终数据分析：坦索罗辛组77名，安慰剂组73名。坦索罗辛组和安慰剂组之间的自发排尿时间没有差异（106 分钟 vs 100 分钟，P=0.5）。此外，从麻醉后护理室出院的时间没有统计学差异（144 分钟 vs 156 分钟，P=0.4）。每组之间的人口统计学和手术细节没有差异。结论 对于因良性疾病接受微创子宫切除术的患者，术前单剂量坦索罗辛不会导致术后排尿时间或出院时间缩短。临床试验注册 ClinicalTrials.gov，NCT04859660。