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尿妇科手术后患者自行拔除导尿管:一项随机对照试验

Patient Removal of Urinary Catheters After Urogynecologic Surgery: A Randomized Controlled Trial.

作者信息

Askew Amy L, Margulies Samantha L, Agu Ijeoma, LeCroy Katie M, Geller Elizabeth, Wu Jennifer M

机构信息

Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics & Gynecology, University of North Carolina at Chapel Hill, and the University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina.

出版信息

Obstet Gynecol. 2024 Feb 1;143(2):165-172. doi: 10.1097/AOG.0000000000005454. Epub 2023 Nov 14.

Abstract

OBJECTIVE

To compare postoperative urinary retention rates in the early postoperative period between home and office catheter removal. Secondary outcomes included pain, difficulty, satisfaction, likelihood to use again, and health care utilization.

METHODS

We conducted a nonblinded, randomized controlled, noninferiority trial of women undergoing surgery for stress incontinence and prolapse from March 2021 to June 2022. Exclusion criteria were preoperative voiding dysfunction (need for self-catheterization or postvoid residual [PVR] greater than 150 mL), urethral bulking, and need for prolonged postoperative catheterization. Participants discharged with indwelling catheters because of an initial failed void trial were randomized 1:1 to home compared with office removal on postoperative day 3-4. For home removal, participants were instructed to remove the catheter at 7 am and to drink two glasses of water. If they had difficulty voiding 5 hours after catheter removal, they came to the office for a void trial. For office removal, participants returned for a backfill void trial with PVR assessment. Our primary outcome was rate of early postoperative urinary retention , defined as confirmed retention (PVR greater than half the voided volume) after catheter removal. Secondary outcomes were assessed at a 2-week call. Health care utilization (telephone calls and office visits) related to catheter issues was also assessed. At 80% power and α=0.05, we needed 100 participants (50/group) to detect a noninferiority margin of 11%.

RESULTS

Among 117 participants, the home (n=59) and office (n=58) removal groups were similar in mean age (60 years vs 61 years), mean body mass index (29 vs 30), pelvic organ prolapse quantification system stage 3 or 4, and proportion who underwent hysterectomy or apical suspension. Sling procedures were more common in the office group (45.8% vs 77.6%). For our primary outcome, the rate of early postoperative retention was 11.9% in the home group and 22.4% in the office group ( P =.13). Our predetermined noninferiority margin was greater than the upper bound of our 95% CI; thus, we conclude noninferiority of home removal. For secondary outcomes, the home removal group was more likely to report "no pain" ( P =.02) and "very likely" to use this method again ( P =.004). There were no differences in difficulty or satisfaction between groups. Number of nursing calls was not different ( P =.66); however, number of office visits was higher in the office group (median 0 [interquartile range 0-1] vs 1 [1-1], P <.001).

CONCLUSION

Postoperative urinary catheter removal by the patient at home was noninferior to office removal when early urinary retention rates were compared. Participants in the home removal group had fewer office visits and reported low pain, low difficulty, and high satisfaction.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov , NCT04783012.

摘要

目的

比较术后早期在家拔除导尿管和在办公室拔除导尿管后的尿潴留发生率。次要结局包括疼痛、困难程度、满意度、再次使用的可能性以及医疗保健利用情况。

方法

我们于2021年3月至2022年6月对接受压力性尿失禁和盆腔器官脱垂手术的女性进行了一项非盲、随机对照、非劣效性试验。排除标准为术前排尿功能障碍(需要自我导尿或残余尿量[PVR]大于150 mL)、尿道填充以及术后需要长期留置导尿管。因初始排尿试验失败而留置导尿管出院的参与者在术后第3 - 4天按1:1随机分为在家拔除导尿管组和在办公室拔除导尿管组。对于在家拔除导尿管,指导参与者在上午7点拔除导尿管并饮用两杯水。如果他们在拔除导尿管5小时后排尿困难,就到办公室进行排尿试验。对于在办公室拔除导尿管,参与者返回进行回填排尿试验并评估PVR。我们的主要结局是术后早期尿潴留发生率,定义为拔除导尿管后确诊的尿潴留(PVR大于排尿量的一半)。在术后2周的随访电话中评估次要结局。还评估了与导尿管问题相关的医疗保健利用情况(电话咨询和门诊就诊)。在检验效能为80%和α = 0.05的情况下,我们需要100名参与者(每组50名)来检测11%的非劣效性界值。

结果

在117名参与者中,在家拔除导尿管组(n = 59)和在办公室拔除导尿管组(n = 58)在平均年龄(60岁对61岁)、平均体重指数(29对30)、盆腔器官脱垂量化系统3期或4期以及接受子宫切除术或顶端悬吊术的比例方面相似。吊带手术在办公室组更常见(45.8%对77.6%)。对于我们的主要结局,在家拔除导尿管组术后早期尿潴留发生率为11.9%,在办公室拔除导尿管组为22.4%(P = 0.13)。我们预先设定的非劣效性界值大于我们95%置信区间的上限;因此,我们得出在家拔除导尿管非劣效的结论。对于次要结局,在家拔除导尿管组更有可能报告“无疼痛”(P = 0.02)且“非常有可能”再次使用这种方法(P = 0.004)。两组在困难程度或满意度方面没有差异。护理电话数量没有差异(P = 0.66);然而,办公室组的门诊就诊次数更高(中位数0[四分位间距0 - 1]对1[1 - 1],P < 0.001)。

结论

在比较早期尿潴留发生率时,患者在家自行拔除术后导尿管并不劣于在办公室拔除。在家拔除导尿管组的门诊就诊次数更少,且报告疼痛程度低、困难程度低和满意度高。

临床试验注册

ClinicalTrials.gov,NCT04783012。

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