Assessing safety and tolerability of super selective alpha-1 adrenergic blockers in infants under 3 years: Insights from a single-center study on lower urinary tract obstruction (LUTO).

ABSTRACT

BACKGROUND: Little is known about alpha blocker use in young children, particularly in those with lower urinary tract obstruction (LUTO). Therefore, we aimed to assess the safety and tolerability of selective alpha-blockers in children under 3 years of age with LUTO. METHODS: A prospectively-collected database captured 93 patients born between 12/2005 and 01/2023. Assessed data included baseline characteristics, ultrasound features, blood pressure (BP), side effects and creatinine values. Primary outcome was side effects or discontinuation of alpha-blockers. Secondary outcomes were BP parameters, growth, and kidney function. Data are shown as median with interquartile range (IQR), Odds Ratio (OR) with 95% CI and mean value with standard deviation (SD). RESULTS: A total of 33 patients less than 3 years of age were started on alpha-blockers at 16.8 ± 11.8 months and followed for 48.9 ± 40.5 months. At last follow-up, no significant effect on systolic/diastolic BP percentiles (p > 0.9 and p > 0.9), creatinine levels (p > 0.9). Weight percentiles increased to the last follow-up (37.8 ± 33.2 vs. 53.6 ± 32.9, p = 0.0133) while height percentiles increased from 28 to 100 days to last follow-up (12.9 ± 18.3 vs. 39.6 ± 35.2, p=0.001). Four patients discontinued alpha-blockers; however, no side-effects were reported during the study period. CONCLUSIONS: No severe clinical or systemic side effects were observed, demonstrating safety and tolerability in young children with LUTO. Although alpha-blockers did not significantly improve kidney function in short term follow-up, and failure to thrive was not observed in these children. Additional studies with more patients are required to assess the optimal dosing and timing leading to maximal benefits for these infants.