Williams Kathryn S, Pilkinton Marjorie L, Shalom Dara F, Winkler Harvey A
Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Northwell Health at Hofstra North Shore-LIJ School of Medicine, Great Neck, NY, USA.
Int Urogynecol J. 2019 Aug;30(8):1247-1252. doi: 10.1007/s00192-018-3783-3. Epub 2018 Oct 6.
To compare the force of the stream (FOS) voiding trial with the standard voiding trial (SVT) after outpatient midurethral sling (MUS) whether or not colporrhaphy was performed.
This is a randomized controlled non-inferiority trial of patients scheduled for MUS or colporrhaphy. Sample size of 102 patients was calculated for 80% power. Patients were randomized to FOS or SVT. Primary outcome was the number of unexpected postoperative visits (UPOVs) for voiding dysfunction (VD) or urinary tract infection (UTI). Voiding dysfunction was defined as urinary retention or post-void residual (PVR) > 200 cc. Subjects rated FOS using a visual analog scale (VAS). Criterion for non-inferiority was an upper limit of < 10% for the 95% CI. Analyses were performed using SAS version 9.4 (SAS Institute. Cary, NC).
One hundred two subjects were included (49 FOS, 53 SVT). Immediate postoperative catheterization for FOS and SVT was 8.2% (n = 4) and 9.4% (n = 5), respectively. Recovery time was significantly less for FOS versus SVT (p = 0.0002). Total UPOVs were five (10.2%) and two (3.8%) for FOS and SVT, respectively. Two FOS subjects who had MUS + colporrhaphy passed their VT and had subsequent UPOVs for VD. No evidence of non-inferiority was noted when comparing FOS to SVT for total UPOVs: CI: 6.0% (-5.2, 17.2) for postoperative VD [CI: 6.1% (-4.0, 16.2)] or UTIs [CI: 0.3% (-9.4, 10.1)].
No evidence of non-inferiority was noted comparing FOS with SVT for unexpected postoperative visits for voiding dysfunction or UTI. This study shows the need for larger studies to assess the use of the FOS method in patients undergoing surgery for prolapse with or without MUS.
比较门诊尿道中段吊带术（MUS）后无论是否进行阴道壁修补术时，流水试验（FOS）排尿试验与标准排尿试验（SVT）的效果。
这是一项针对计划进行MUS或阴道壁修补术患者的随机对照非劣效性试验。计算得出样本量为102例患者时检验效能为80%。患者被随机分为FOS组或SVT组。主要结局指标是因排尿功能障碍（VD）或尿路感染（UTI）进行的意外术后复诊次数（UPOV）。排尿功能障碍定义为尿潴留或残余尿量（PVR）>200cc。受试者使用视觉模拟量表（VAS）对FOS进行评分。非劣效性标准为95%置信区间（CI）的上限<10%。使用SAS 9.4版软件（SAS Institute，北卡罗来纳州卡里）进行分析。
纳入102名受试者（49例FOS组，53例SVT组）。FOS组和SVT组术后即刻导尿率分别为8.2%（n = 4）和9.4%（n = 5）。FOS组的恢复时间显著短于SVT组（p = 0.0002）。FOS组和SVT组的总UPOV次数分别为5次（10.2%）和2次（3.8%）。两名接受MUS + 阴道壁修补术的FOS组受试者通过了排尿试验，但随后因VD进行了UPOV。在比较FOS组和SVT组的总UPOV次数时，未发现非劣效性证据：术后VD的CI为6.0%（-5.2，17.2）[CI：6.1%（-4.0，16.2）]或UTI的CI为0.3%（-9.4，10.1）。
在因排尿功能障碍或UTI进行的意外术后复诊方面，比较FOS与SVT未发现非劣效性证据。本研究表明需要开展更大规模的研究来评估FOS方法在接受或未接受MUS的脱垂手术患者中的应用。
