Efficacy of Levocetirizine in Reducing Double-J Stent-Related Symptoms: A Double-Blind Pilot Randomized Controlled Trial.

Abstract

Purpose: The aim of this study is to evaluate the safety and efficacy of levocetirizine in reducing ureteral stent-related symptoms.

Methods: In this single-center randomized controlled trial, 85 patients requiring double-J stent placement, 3 patients were excluded and 82 were allocated to start preoperatively levocetirizine 5 mg daily (Group B n = 41) or placebo (Group A n = 41) from stent insertion until stone removal. Primary outcomes were assessed using the Ureteral Stent Symptom Questionnaire (USSQ) and visual analog scale (VAS) for pain. Secondary outcomes included macroscopic assessment of ureteral inflammation and stent calcification during ureteroscopy for stone removal within 20 days.

Results: Out of 82 participants included, three patients were excluded before analysis due to loss to follow-up or hospitalized for UTI that mimics stent-related symptoms. 79 patients were considered for final analysis. Group B showed a statistically significant reduction in stent-related morbidity USSQ across all subgroups compared to the placebo group and a lower VAS pain score (p < 0.05). Macroscopic assessment during stent removal also demonstrated statistically significantly less ureteral inflammation in Group B (17.07%) vs. 82.93% in Group A (p < 0.005).

Conclusion: This pilot study indicates that levocetirizine effectively reduces stent-related symptoms and maintains a good safety profile. These findings suggest that levocetirizine may be a well-tolerated adjunct therapy for managing stent discomfort. Trial registration: Clinical trial.gov.identifier: LBCTR2025075754.