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阴道重建术后膀胱排空不全会女性行二次排尿试验的最佳时机:一项随机试验。

Optimal timing of a second postoperative voiding trial in women with incomplete bladder emptying after vaginal reconstructive surgery: a randomized trial.

机构信息

Female Pelvic Medicine and Reconstructive Surgery, the Departments of Urology and Obstetrics and Gynecology, Wake Forest Baptist Health, Winston-Salem, NC.

Female Pelvic Medicine and Reconstructive Surgery, the Department of Gynecology, Cleveland Clinic Florida, Weston, FL.

出版信息

Am J Obstet Gynecol. 2020 Aug;223(2):260.e1-260.e9. doi: 10.1016/j.ajog.2020.06.001. Epub 2020 Jun 3.

DOI:10.1016/j.ajog.2020.06.001
PMID:32502559
Abstract

BACKGROUND

Rates of postoperative incomplete bladder emptying vary significantly after pelvic reconstructive surgery. With enhanced recovery protocols the paradigm is shifting towards same-day discharge and the rates of incomplete bladder emptying are expected to increase. The optimal length of time for postoperative catheter drainage has not been clearly established. There are no current studies that assess the optimal timing of a repeat voiding trial in women who have unsuccessful same day voiding trials.

OBJECTIVE

This study aimed to compare the outcomes of a second voiding trial performed 2-4 days (earlier group) vs 7 days (later group) postoperatively in women with incomplete bladder emptying after vaginal prolapse surgery. Secondary aims included postoperative urinary tract infection rates, total days with a catheter, and patient-reported catheter bother between groups.

STUDY DESIGN

Across 2 sites, women undergoing multicompartment vaginal repair were enrolled. Within 6 hours postoperatively, subjects had an active retrograde voiding trial. Those who passed this voiding trial exited the study; those who had persistent incomplete bladder emptying (postvoid residual >100 mL) had a transurethral indwelling catheter placed and were randomized to return for an earlier (postoperative day 2-4) vs later (postoperative day 7) follow-up office voiding trial. Subjects were followed for 6 weeks after surgery. The primary outcome was the rate of unsuccessful repeat office voiding trial. Secondary outcomes included rates of urinary tract infection, total days with a catheter, and subjective catheter bother. A power calculation based on a projected 31% difference, a power of 0.8, and an alpha of 0.05 revealed that 30 subjects were needed in each group.

RESULTS

A total of 102 subjects were enrolled; 38 exited on postoperative day 0, leaving 64 subjects for randomization (4 of whom withdrew after randomization). A comparison of data revealed that randomization was effective, with no differences between the earlier and later groups in terms of demographic data or surgical procedures. Using an intention-to-treat analysis, women in the earlier group were more likely to be unsuccessful in their follow-up office voiding trial (23.3%) than the later group (3.3%), with a risk difference of 20% (95% confidence interval, 3.56-36.44) and a relative risk of 7.00 (95% confidence interval, 0.92-53.47; P=.02). A number-needed-to-treat calculation found that for every 5 patients using a catheter for 7 days postoperatively, 1 case of persistent postoperative incomplete bladder emptying was prevented. Rates of catheter bother did not differ between groups at the time of the follow-up office voiding trial or at 6 weeks (P=.09 and P=.20, respectively). Urinary tract infection rates were higher in the earlier group but did not reach statistical significance (23% vs 7%, P=.07). Regression analysis revealed that subjects who required additional pain medication refills were 9.6 times (95% confidence interval, 1.24-73.77) more likely to have persistent incomplete bladder emptying after the follow-up office voiding trial.

CONCLUSION

Women with incomplete bladder emptying after multicompartment prolapse repair had a 7-fold higher risk of an unsuccessful repeat office voiding trial if performed within 4 days of surgery than when performed within 7 days of surgery. In addition, requiring additional prescriptions for analgesia increased the risk of an unsuccessful follow-up office voiding trial.

摘要

背景

盆腔重建手术后,不完全排空膀胱的发生率差异很大。随着加速康复方案的实施,术后出院时间提前,预计不完全排空膀胱的发生率将会增加。术后留置导尿管的最佳时间尚未明确。目前尚无研究评估在同一天排尿试验失败的女性中,重复排尿试验的最佳时机。

目的

本研究旨在比较阴道脱垂手术后不完全排空膀胱的女性在术后 2-4 天(早期组)和 7 天(晚期组)进行第二次排尿试验的结果。次要目标包括术后尿路感染率、带管总天数和两组之间患者报告的导管不适。

研究设计

在两个地点,纳入接受多间隙阴道修复的女性。术后 6 小时内,患者进行主动逆行排尿试验。通过该排尿试验的患者退出研究;那些仍有不完全排空膀胱的患者(残余尿>100ml)放置经尿道留置导尿管,并随机分为早期(术后第 2-4 天)或晚期(术后第 7 天)门诊随访排尿试验组。患者在术后 6 周内进行随访。主要结局为重复门诊排尿试验不成功的发生率。次要结局包括尿路感染率、带管总天数和主观导管不适。根据预测 31%的差异、0.8 的功效和 0.05 的α值进行的功效计算表明,每组需要 30 名受试者。

结果

共纳入 102 名受试者;38 名受试者在术后第 0 天退出,64 名受试者接受随机分组(其中 4 名受试者在随机分组后退出)。数据比较显示,随机分组有效,早期组和晚期组在人口统计学数据或手术程序方面无差异。采用意向治疗分析,早期组女性在门诊随访排尿试验中更可能不成功(23.3%),而晚期组为 3.3%,风险差异为 20%(95%置信区间,3.56-36.44),相对风险为 7.00(95%置信区间,0.92-53.47;P=.02)。需要治疗的人数计算发现,每 5 名患者术后使用导尿管 7 天,就可以预防 1 例术后不完全排空膀胱。在门诊随访排尿试验时或 6 周时,两组的导管不适率无差异(P=.09 和 P=.20)。早期组的尿路感染率较高,但无统计学意义(23% vs 7%,P=.07)。回归分析显示,需要额外开具止痛药处方的患者在门诊随访排尿试验后持续存在不完全排空膀胱的可能性增加 9.6 倍(95%置信区间,1.24-73.77)。

结论

多间隙脱垂修复术后不完全排空膀胱的女性,如果在术后 4 天内进行第二次门诊排尿试验,其失败的风险比在术后 7 天内进行的风险高 7 倍。此外,需要额外开具镇痛药处方会增加门诊随访排尿试验失败的风险。

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Methods of postoperative void trial management after urogynecologic surgery: a systematic review and meta-analysis.妇科泌尿手术后的术后排尿试验管理方法:系统评价和荟萃分析。
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