Objective To observe the efficacy and safety of Mirabelone in the treatment of distal ureteral calculi (stone length ≤10 mm).Methods The clinical data of 120 patients with distal ureteral calculi who were treated with Tamsulosin or a combination of Tamsulosin and Mirabelone at Xiamen Susong Hospital or Jiangning Hospital Affiliated to Nanjing Medical University from January 2022 to January 2023 were retrospectively analyzed. Patients were divided into an experimental group and a control group according to different treatment methods, with 60 cases in each group. Patients in the experimental group were orally administered mirabegron and tamsulosin. The control group patients were orally administered tamsulosin.The stone clearance rate (SFR) and the frequency of renal colic were compared between the two groups by imaging examination at the 1st, 2nd and 4th week.Results Through stratified analysis of stone size, the results showed that in the experimental group, in the patients with distal ureteral calculi with stone length≤5 mm, the first week after treatment (63.3% vs. 39.3%, P=0.036), the second week after treatment (83.3% vs. 57.1%, P=0.029) and the fourth week (93.3% vs. 67.9%, P=0.013), SFR was higher than that of control group, and the differences were statistically significant (all P<0.05). The daily frequency of renal colic in the experimental group was lower than that in the control group, and the differences were statistically significant [(1.3±0.5)% vs. (1.6±0.7)%, P=0.008].Conclusions Mirabelone can effectively improve SFR in patients with distal ureteral calculi with length diameter≤5 mm, but has no significant effect on distal ureteral calculi with length diameter>5 mm. At the same time, Mirabelone can reduce the frequency of distal ureteral stone colic with stone length≤10 mm, the use of analgesic drugs is less, and the overall incidence of adverse drug reactions is low.