INTRODUCTION: Active void trials (AVT) are the standard of care following reconstructive pelvic surgery. However, there is little evidence on optimal AVT performance. Data are lacking to guide the time allotted after removal of the Foley catheter postoperatively. OBJECTIVE: The primary aim of this trial is to compare day of surgery AVT pass rates between patients who are given up to 30 minutes versus up to 60 minutes to void following pelvic reconstructive surgery. Secondary objectives include time spent in the Post-Anesthesia Care Unit (PACU) before discharge, rate of urinary retention after initial pass, and rate of urinary tract infection (UTI) between study arms. METHODS: This study is a randomized controlled trial performed at a tertiary care center and included patients undergoing pelvic reconstructive surgery to treat pelvic organ prolapse or stress urinary incontinence where an AVT was indicated postoperatively. Participants were randomized to one of two arms: an immediate arm, in which patients were given up to 30 minutes to void, or a delayed arm, in which patients were given up to 60 minutes to void after removal of the Foley catheter. Participants were required to void at least two-thirds of their bladder volume to pass. We assumed a pass rate of 50% for the immediate arm group and a 70% pass rate for the delayed arm group. A sample size of 91 per group (n=182) was needed to achieve 80% power to detect a 20% difference in the voiding pass rate with a 0.05 significance level. RESULTS: Between July 7, 2023, and August 21, 2024, 266 participants were screened, and 231 participants were randomized. 194 patients underwent surgical procedures, and 185 patients were included in the primary outcome: 94 in the immediate arm and 91 in the delayed arm (Figure 1). The two arms were similar in baseline demographics, extent of prolapse, and surgeries performed (Table 1). The overall AVT pass rate was 55.7%. There was no difference in rates of passing the AVT, urinary retention, or UTI between arms. Time spent in the PACU was significantly shorter in the immediate arm (203.8±62.6 vs 234.6±78.1 minutes, p=0.005) (Table 2a). The overall pass rate after the first failed AVT was highly reassuring (90%) when performed at a median of 3 days (IQR 3.4) postoperatively. Patients who voided within 30 minutes during their AVT had a higher likelihood to pass, regardless of study arm assignment (81.4% vs 47.1%, p<0.001) and spent significantly less time in the PACU (199.8±71.0 vs 242.7±54.0 minutes, p=0.002) (Table 2b). CONCLUSIONS: The pass rate for AVT after reconstructive pelvic surgery is lower than expected in our sample. Allowing patients up to 60 minutes to void as part of an AVT does not increase pass rates compared to up to 30 minutes. Thirty-minute AVT decreases time spent in PACU before hospital discharge. There is no difference between UTI and urinary retention rates between the two arms.Figure 1Table 1Table 2
Fertel et al. (Fri,) studied this question.