Pilot study of a Foley catheter with micropore-delivered analgesia for reducing catheter-associated pain and discomfort in patients with repeated catheterizations

Dong Sup Lee; Yun-Hee Lee; Woo Bae Kim; Jong Jeong Kim; Sung Chul Lee; U Syn Ha

doi:10.1136/rapm-2025-107084

Pilot study of a Foley catheter with micropore-delivered analgesia for reducing catheter-associated pain and discomfort in patients with repeated catheterizations

Reg Anesth Pain Med. 2026 Feb 25:rapm-2025-107084. doi: 10.1136/rapm-2025-107084. Online ahead of print.

Authors

Dong Sup Lee¹, Yun-Hee Lee¹, Woo Bae Kim², Jong Jeong Kim³, Sung Chul Lee⁴, U Syn Ha⁵

Affiliations

¹ Department of Urology, The Catholic University of Korea College of Medicine, Seoul, The Republic of Korea.
² Songmin Medicare Co, Ltd, Seoul, The Republic of Korea.
³ AP MDS Co., Ltd, Incheon, The Republic of Korea.
⁴ TFRIENDS Co., Ltd, Incheon, The Republic of Korea.
⁵ Department of Urology, The Catholic University of Korea College of Medicine, Seoul, The Republic of Korea ushamd@catholic.ac.kr.

PMID: 41741173
DOI: 10.1136/rapm-2025-107084

Abstract

Objective: This study aimed to evaluate the effectiveness of the modified catheter in alleviating catheter-related pain.

Methods: This randomized controlled trial included 40 patients with similar characteristics scheduled for repeat transurethral resection of bladder tumor. At the end of surgery, a specially designed urethral catheter with multiple micropores enabling direct administration of local analgesic onto the urethral mucosa was inserted. In the treatment group, 0.5% ropivacaine was infused at 1 mL/hour (5 mg/hour), whereas the control group received normal saline. Visual Analogue Scale (VAS), Morphine Milligram Equivalents (MME), International Prostate Symptom Score (IPSS) and a 5-point Likert scale for willingness to reuse the catheter were assessed.

Results: During the first 6 postoperative hours, mean VAS increased by 1.80±1.06 in the treatment group and by 4.70±0.98 in the control group. The between-group mean difference was -2.90 (95% CI -3.55 to -2.25). From 6 to 24 hours, the change in VAS was -0.30±0.57 in the treatment group and -0.60±1.05 in the control group, with no meaningful between-group difference (mean difference, 0.30; 95% CI -0.24 to 0.84). At 24 hours, mean VAS was 1.75±1.12 in the treatment group and 4.25±0.97 in the control group. Cumulatively, VAS scores were lower in the treatment group compared with the control group (between-group mean difference -2.6, and 95% CI -3.22 to -1.97). The cumulative MME was significantly higher in the control group than in the treatment group (p<0.01), and MME was positively correlated with changes in VAS over 24 hours (R² for control and treatment groups were 0.33 and 0.31, respectively). Differences were also observed in the change of IPSS and its storage subscore between groups (p<0.01). The 5-Point Likert Scale for willingness to use the catheter was significantly higher in the treatment group than in the control group (p<0.01).

Conclusion: Our findings indicate that the novel catheter provides early pain control, reduces postoperative analgesic needs and lessens storage symptoms after catheter removal, improving patient satisfaction.

Keywords: Anesthesia, Regional; Pain, Postoperative; TECHNOLOGY.