Efficacy and safety of analgesic-eluting urethral catheter after urogynecological surgery: a prospective randomized controlled trial

Catheter-related bladder discomfort (CRBD) and urethral pain are frequent issues following urethral catheterization, particularly after urogynecological procedures. This study evaluates the efficacy and safety of a ropivacaine-eluting urethral catheter in reducing CRBD. Sixty female patients undergoing urogynecological surgery were randomized into three groups: Control arm, 0.5% ropivacaine 1 mL/hr (Study arm 1), and 0.5% ropivacaine 2 mL/hr (Study arm 2), with 20 patients each. CRBD incidence and severity at 24 h postoperatively were assessed. Adverse events and patient discomfort were evaluated as secondary outcomes. Baseline demographics including age, ASA score, body mass index, and surgery type were not significantly different among groups (all p > 0.05). CRBD incidence was 65.0% (Control arm), 36.8% (Study arm 1), and 21.1% (Study arm 2) (p = 0.018). CRBD severity was significantly lower in both study arms compared to control (p < 0.001). No significant differences in adverse events were observed among groups. Catheter-related discomfort(p = 0.008) and patient preference for future reuse of catheter (p = 0.004) differed significantly. An appropriate dose of ropivacaine eluting urethral catheter significantly reduced the incidence and severity of CRBD and the discomfort with catheter usage in patients undergoing urogynecological surgery without significant adverse events while achieving preference for future reuse of analgesic-eluting catheters.Registry: The Clinical Research Information Service (CRIS), Number: KCT0010934, Registration date: 22nd August 2025. (Direct link: https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=L&pageSize=10&page=undefined&seq=31096&status=5&seq_group=31066).