Effect of Local Anesthetic-Eluting Foley Catheter (FreeFoley) on Urethral Pain and Discomfort After HoLEP: A Multicenter Prospective Controlled Study

Background and objective Benign prostatic hyperplasia (BPH) is common in middle-aged and older men and often requires surgical intervention. Postoperative Foley catheterization frequently causes urethral pain and catheter-related bladder discomfort (CRBD). Systemic analgesics may be insufficient and can be contraindicated in older patients. This study evaluated the efficacy and safety of a local anesthetic-eluting Foley catheter (FreeFoley) for reducing urethral pain and discomfort after holmium laser enucleation of the prostate (HoLEP). Methods In this prospective multicenter observational study, 108 male patients aged 50–79 yr undergoing HoLEP were allocated to either an experimental group (FreeFoley with 2% lidocaine solution, infused at 1 ml/h) or a control group (FreeFoley with normal saline, 1 ml/h). Pain and discomfort were assessed using the visual analog scale (VAS) during postoperative recovery and immediately before catheter removal. Primary outcomes were VAS scores and systemic analgesic use; secondary outcomes included catheter-related complications and patient satisfaction. Key findings and limitations VAS scores were significantly lower in the lidocaine group than in the control group on the day of surgery (3 [2–4] vs 4 [3–5], median difference [MD], −1.1, 95% CI, −1.7 to −0.4; p < 0.001) and at catheter removal (2 [1–3] vs 3 [2–4], MD, −0.6, 95% CI, −1.2 to −0.2, p < 0.001). Analgesic use was markedly reduced (5.6% vs 28%; risk ratio [RR], 0.20, 95% CI, 0.10–0.70, p < 0.001). Complications occurred in 11% of patients in both groups (RR, 1.00; 95% CI, 0.36–2.78). Limitations include nonrandomization, modest sample size, and short follow-up duration. Conclusions and clinical implications The lidocaine-eluting Foley catheter was associated with modest reductions in postoperative urethral pain, discomfort, and systemic analgesic requirements without an observed increase in complications. Further well-controlled studies are warranted to confirm the clinical benefit before routine adoption. Trial registration: Clinical Research Information Service (CRIS); KCT0011090.