Efficacy and safety of an improved Xiao-Xu-Ming-Tang traditional Chinese medicine hot compress for preventing catheter-related bladder discomfort: a multicenter, randomized, double-blind, controlled trial

Objectives Catheter-related bladder discomfort (CRBD) occurs in 47–95% of patients recovering from general anesthesia, causing discomfort and increasing the risk of postoperative delirium. Xiao-Xu-Ming-Tang is a traditional Chinese medicine (TCM) concoction that has demonstrated efficacy in relieving urinary symptoms. Thus, we propose the use of this improved traditional Chinese medicine concoction in the form of a hot compress as an inexpensive, effective, and simple intervention for preventing postoperative CRBD. Methods This was a multicenter, randomized, double-blind, controlled study. Ninety patients who underwent transurethral ureteral laser lithotripsy at three centers were included. Patients were randomly divided into two groups: the Chinese medicine (CM) group and the control group (salt packet (SP) group), at a ratio of 1:1. In the CM group, a hot compress (40–45 °C) of improved Xiao-Xu-Ming-Tang mixed with salt was placed above the pubic symphysis immediately after intubation. In the control group, one-tenth of the improved Xiao-Xu-Ming-Tang and salt mixture was used. Results The primary endpoint is the incidence of moderate or severe CRBD at 30 min after surgery. The secondary endpoints are the incidence of moderate-to-severe CRBD, the Numerical Rating Scale (NRS) Pain score, the incidence of skin discomfort above the pubic symphysis, and the vital signs (the blood pressure, heart rate, and oxygen saturation), and patient satisfaction after surgery. Discussion The aim of this trial was to evaluate the effect and safety of a hot compress of an improved Xiao-Xu-Ming-Tang powder and salt mixture for moderate and severe CRBD. These findings may provide a basis for the prevention of CRBD in clinical practice. Clinical trial registration http://itmctr.ccebtcm.org.cn/ , Identifier: ITMCTR2025000321.