Efficacy of Open‐Ended Urinary Catheters in Preventing Catheter‐Related Bladder Discomfort: A Randomized Controlled Trial

Abstract

OBJECTIVE: Catheter-related bladder discomfort (CRBD) is a common postoperative complication following urological procedures, causing significant distress and reducing patient satisfaction. Although pharmacological interventions have been investigated, a more definitive approach is warranted. This study evaluated whether an open-ended Foley catheter (OEFC) reduces the incidence and severity of CRBD compared with a conventional Foley catheter (FC). MATERIALS: In this exploratory, parallel-group, single-blind, randomized controlled trial conducted at Hiroshima University Hospital, 100 patients undergoing transurethral resection of a bladder tumor or robot-assisted surgery for renal, renal pelvic, or ureteral malignancies were randomized 1:1 to receive either an OEFC or a standard FC. The primary endpoint was the incidence of CRBD at 6 h postoperatively. Secondary endpoints included the incidence and severity of CRBD and urethral pain, and the frequency of pharmacological intervention at predefined postoperative time points. RESULTS: Ninety-four patients were included in the full analysis set (47 per group). At 6 h postoperatively, CRBD incidence was significantly lower in the OEFC group than in the FC group (42.6% vs. 68.1%; p = 0.012). The OEFC group consistently demonstrated reduced CRBD incidence and severity compared with the FC group during the first 6 h. Urethral pain scores and analgesic use were comparable between groups. Subgroup analyses indicated that the preventive effect of OEFC was particularly notable in non-transurethral resection of bladder tumor patients. CONCLUSIONS: OEFC placement represents a broadly applicable and effective strategy to reduce CRBD following urological surgery. Catheter tip design appears to play a pivotal role in CRBD prevention.