Urinary Catheters

This study aims to systematically evaluate the safety and efficacy of different early urinary catheter removal strategies following radical resection of mid-low rectal cancer. Current clinical practice faces controversy regarding the optimal timing of catheter removal (24 hours vs. 48 hours) and lacks precise preventive measures for patients at high risk of postoperative acute urinary retention (AUR). To address these issues, this study is designed as a three-arm randomized controlled trial, directly comparing three management protocols: catheter removal at 24 hours postoperatively, catheter removal at 48 hours postoperatively, and urinary catheter removal within 24 hours combined with prophylactic tamsulosin. The primary endpoint is the rate of recatheterization within 7 days after the initial removal, with secondary endpoints comprehensively assessing urinary tract infections, voiding function, and postoperative complications. The ultimate goal is to provide high-quality evidence-based medical evidence to establish a precise and standardized clinical pathway for postoperative catheter management.

People who rely on long-term indwelling urinary (Foley) catheters often experience recurrent urinary tract infections and catheter blockages that require unscheduled catheter changes, additional antibiotics, and emergency visits. These complications reduce quality of life and increase healthcare use. The NowCath Foley is an all-silicone indwelling urinary catheter with two additional drainage eyelets positioned below the retention balloon. A thin silicone skirt covers the eyelets to reduce suction against the bladder wall. The design is intended to improve bladder emptying and reduce mucosal contact, which may in turn lower the rate of catheter-associated urinary tract infections (CAUTIs) and blockages compared with a conventional all-silicone Foley catheter. The REDUCE study is a multi-centre, randomized, blinded, controlled crossover clinical investigation conducted in Denmark. The primary goal is to determine whether the NowCath Foley catheter can reduce incidence of CAUTI over 12 weeks compared to a conventional long-term indwelling Foley catheter in an adult population using indwelling urethral or suprapubic Foley catheters . The participants (n=160) are cared for and enrolled by community nursing services in the Ikast-Brande and Holstebro municipalities in collaboration with the coordinating site at Regional Hospital Gødstrup. Each participant will use both the NowCath Foley and a conventional all-silicone Foley catheter (Rüsch Brillant, Teleflex Medical) in a randomized sequence, for 12 weeks each (24 weeks total). The primary outcome is the rate of catheter changes per 100 catheter days. Secondary outcomes include CAUTI incidence, blockage incidence, residual urine volume, encrustation, antibiotic use, quality of life, patient comfort, safety, and cost-effectiveness. During phase 1, participants will be randomised to either NowCath or the conventional Foley catheter and will be seen at weeks 0 and 12. At week 12 participants will be crossed-over to phase 2, where they will receive the other catheter not allocated in phase 1 and will be seen at weeks 12 and 24. As the participants would default to the comparator catheter as part of standard of care, the wash-out period is minimal.