Effect of intermittent urethral catheter clamping combined with active urination training (ICCAUT) strategy on postoperative urinary retention after radical rectal cancer surgery: single- center randomized controlled trial (ICCAUT -2) study protocol

Abstract

Background Urinary catheter placement is routinely performed after proctectomy. However, there is uncertainty regarding the need for bladder training before catheter removal. This trial aims to examine the effect of intermittent catheter clamping combined with active urination training (ICCAUT) on urinary retention and secondary catheterization after proctectomy. Methods Eligible patients will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter combined with active urination training before its removal, whereas the patients in the free drainage group will not receive any specific training. The urinary catheter will be removed on postoperative day 2 in both groups after emptying the bladder. The primary endpoint is the incidence of secondary catheterization owing to urinary retention. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, residual urine volume after first urination, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, and urinary function within 30 days. Discussion This trial will investigate whether the ICCAUT strategy can affect the rate of secondary catheterization compared with direct catheter removal in patients undergoing rectal cancer surgery. The findings of this study will provide valuable evidence on the manipulation of urinary catheters and will help guide clinical practice. Trial registration The trial was registered at ClinicalTrials.gov website, NCT06217016. First posted on January 22, 2024. https://www.clinicaltrials.gov/study/NCT06217016?cond=NCT06217016&rank=1